CA3175350A1 - Methods of preventing and treating covid-19 infection - Google Patents

Methods of preventing and treating covid-19 infection

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Publication number
CA3175350A1
CA3175350A1 CA3175350A CA3175350A CA3175350A1 CA 3175350 A1 CA3175350 A1 CA 3175350A1 CA 3175350 A CA3175350 A CA 3175350A CA 3175350 A CA3175350 A CA 3175350A CA 3175350 A1 CA3175350 A1 CA 3175350A1
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Prior art keywords
vitamin
administering
zinc
day
hydroxychloroquine
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French (fr)
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Sabine HAZAN
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Individual
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Individual
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Priority claimed from US17/026,051 external-priority patent/US11253534B2/en
Priority claimed from US16/953,674 external-priority patent/US20210290718A1/en
Priority claimed from US17/114,271 external-priority patent/US11278520B2/en
Application filed by Individual filed Critical Individual
Publication of CA3175350A1 publication Critical patent/CA3175350A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47064-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A method of preventing COVID-19 infection comprising the steps of: administering hydroxychloroquine; vitamin C; vitamin D; and zinc; and monitoring the individuals condition over a pre-determined amount of time to determine the individual does not become infected with COVID-19. A method of treating an individual infected with COVID-19 comprising the steps of: administering hydroxychloroquine; azithromycin; vitamin C; vitamin D; and zinc; and monitoring the individual's condition over a pre-determined period of time to determine whether the individual is no longer infected with COVID-19. The methods can further comprise administering ivermectin in and optionally doxycycline.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to United States Non-Provisional Patent Application =No. 17/114,271, titled "Method of Preventing COVID-19 Infection,"
filed December 7, 2020, United States Non-Provisional Patent Application No.
16/953,674, titled "Method of Preventing and Treating COV1D-19 Infection," filed November 20, 2020, United States Provisional Patent Application No. 63/110,877, titled "Methods of Preventing COVID-19 Infection with Ivermectin," filed November 6, 2020, United States Non-Provisional Patent Application No. 17/026,051, titled "Methods of Preventing and Treating COVID-Infection," filed September 18, 2020, United States Provisional Patent Application No.
63/022,371, titled "Method of Treating and Preventing COVID-19 infection,"
filed May 8, 2020, United States Provisional Patent Application No. 63/022,368, titled "Method of Using Vitamin C, Vitamin D, Zinc, and Optionally Hydroxychloroquine, to Prevent Infection," filed May 8, 2020, United States Provisional Patent Application No. 63/002,494, titled "Method of Using Vitamin C, Vitamin D, Zinc, and Optionally Hydroxychloroquine, to Prevent COVID-19 Infection," filed March 31, 2020, United States Provisional Patent Application No. 63/001,161, titled "Method of Using Aerosolized Hydroxychloroquine, Vitamin C, and Zinc to Treat Covid-19 Infection," filed March 27, 2020, United States Provisional Patent Application No. 62/993,345, titled "Method of Treating and Preventing COVID-19 Infection," filed March 23, 2020, United States Provisional Patent Application No. 62/993,159, titled "Method of Treating COVID-19 Infection with Antimicrobials," filed March 23, 2020, and United States Provisional Patent Application No.
62/993,370, titled "Method of Treating COVID-19 Infection with Antimicrobials," filed March 23, 2020, the contents of which are incorporated by reference in their entirety.

BACKGROUND

is a novel betacoronavinz that originated in bats in the city of Wuhan, China. This disease has rapidly spread to become a worldwide pandemic, as declared by the World Health Organization (WHO). Symptoms of COVID-19, including fever, myalgia, coughing and shortness of breath, may appear from 2 and 14 days after exposure. Approximately 20% of patients progress to severe illness, including pneumonia, respiratory distress, and even death. Cases in the US have increased five-fold over the last week, alone. The disease is spreading rapidly, and a cure is desperately needed.

Nucleotide analogues, protease inhibitors and altered cellular bonding due to pH
change will maximize host protection by: optimizing levels of gamma interferon and reducing the level of pathogenic microbes in the airways, especially in 'at risk' patients.
100041 It is known that single anti-viral agents work poorly when used alone in other chronic viral infections such as Hepatitis C or HIV infection. Therefore, the greater the number of anti-viral agents used in combination, the greater the cure rate.
100051 Thus, there is a significant unmet need for preventing and treating this viral infection. The present invention addresses this need.
SUMMARY
100061 In a first embodiment, the invention herein is directed to my method of preventing COVID-19 infection in an individual. The method of prevention comprises the steps of providing an individual that is not infected with COVID-19;
administering four antimicrobials to the individual, wherein the antimicrobials comprise:
chloroquine or hydroxychloroquine; vitamin C; vitamin D; and zinc; and monitoring the individual's condition over a pre-determined amount of time to determine the individual does not become infected with COVID-19.
2 100071 Optionally, the method of prevention comprises administering hydroxychloroquine in a daily dosage range of 20 mg to 2,000 mg; administering vitamin C
in a daily dosage range of 250 mg to 10,000 mg; administering vitamin D in a daily dosage range of 1,000 IU to 100,000 IU, and administering zinc in a daily dosage range of 5 mg to 100 mg.

Optionally, the method of prevention comprises administering, on day 1: 400 mg of hydroxychloroquine; 3,000 mg of vitamin C; 3,000 IU of vitamin D; and 50 mg of zinc;
and administering on day 2: 3,000 mg of vitamin C; 3,000 Ili of vitamin D; and 50 mg of zinc.

Optionally, the method of prevention comprises administering ivermectin in a daily dosage range of 12 mg to 18 mg and, optionally, administering doxycycline in a daily dosage amount of 400 mg.
100101 In a second embodiment, the invention herein is directed to my method of treating an individual infected with COVID-19. The method of treatment comprises the steps of providing an individual infected with COVID-19; administering five antimicrobials to the individual, wherein the antimicrobials comprise: chloroquine or hydroxychloroquine;
azithromycin; vitamin C; vitamin D; and zinc; and monitoring the individuals condition over a pre-determined period of time to determine whether the individual is no longer infected with COVID-19.

Optionally, the method of treatment comprises administering hydroxychloroquine in daily dosage range of 20 mg to 2,000 mg; administering azithromycin in a daily dosage range of 250 mg to 500 mg: administering vitamin C in a daily dosage range of 250 mg to 10,000 mg; administering vitamin D in a daily dosage range of 1,000 1U to 100,000 IU; and administering zinc in a daily dosage range of 5 mg to 100 mg.
3 100121 Optionally, the method of treatment comprises the steps of administering, on day 1: 400 mg of hydroxychloroquine; 500 mg of azithromycin; 3,000 mg of vitamin C; 3,000 1U
of vitamin D; and 50 mg of zinc; administering daily, on days 2 to 400 mg of hydroxychloroquine; 250 mg of azithromycin; 3,000 mg of vitamin C; 3,000 1U of vitamin D;
and 50 mg of zinc; and administering daily, on days 6 to 10: 400 mg of hydroxychloroquine;
3,000 mg of vitamin C; 3,000 1U of vitamin D; and 50 mg of zinc.
10013] The method of treatment can further comprise administering daily, on days 6 to 10, administering 250 mg of azithromycin.
100141 Optionally, the method of treatment comprises administering ivermectin in a daily dosage range of 12 mg to 18 mg and, optionally, administering doxycycline in a daily dosage amount of 400 mg.
BRIEF DESCRIPTION OF THE DRAWINGS
100151 Further advantages of the present invention may become apparent to those skilled in the art with the benefit of the following detailed description of the preferred embodiments and upon reference to the accompanying drawings in which:
100161 FIG. 1 is a flow chart depicting the steps of a first method of preventing infection of an individual with COVID-19;
100171 FIG. 2 is a flow chart depicting the steps of a second method of preventing infection of an individual with COVID-19;
pal FIG. 3 is a flow chart depicting the steps of a first method of treating an individual infected with COVTD-19;
4 100191 FIG. 4 is a flow chart depicting the steps of a second method of treating an individual infected with COVID-19;
100201 FIG. 5A is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 1 of Example 6;
100211 FIG. 5B is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 3 of Example 6;
100221 FIG. 5C is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 4 of Example 6;
[0023] FIG. 5D is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 6 of Example 6;
100241 FIG. 5E is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 8 of Example 6;
100251 FIG. 5F is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 10 of Example 6;
100261 FIG. 5G is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 11 of Example 6; and 100271 FIG. 5H is a graphical representation of whole genome alignment of SARS-CoV-2 in patient 12 of Example 6.

DETAILED DESCRIPTION
100281 As used herein, the following terms and variations thereof have the meanings given below, unless a different meaning is clearly intended by the context in which such term is used.
100291 The terms "a," "an," and "the" and similar referents used herein are to be construed to cover both the singular and the plural unless their usage in context indicates otherwise.
100301 As used in this disclosure, the term "comprise" and variations of the term, such as -comprising" and "comprises," are not intended to exclude other additives, components, integers ingredients or steps.

Referring now to the drawings, wherein like reference numerals designate identical or corresponding features throughout the several views. Further, described herein are certain non-limiting embodiments of my pipeline filter assembly for pool filtering and maintenance.
100321 The following discussion describes in detail multiple embodiments of the invention with several variations of those embodiments. This discussion should not be construed. however, as limiting the invention to those particular embodiments.
Practitioners skilled in the art will recognize numerous other embodiments as well.
100331 In a first embodiment, the present invention is directed to a first method of preventing COV1D-19 infection in an individual. The method involves administration of chloroquine or hydroxychloroquine, Vitamin C, Vitamin D. and Zinc. Both methods are discussed in greater detail below.

100341 Referring now to Figure 1, there is shown the first method of prevention. The method of prevention comprises administering four different antimicrobials.
The four antimicrobials comprise: chloroquine or hydroxychloroquine, vitamin C, vitamin D; and zinc.
100351 Day 1 the individual takes the following, ideal, regimen outlined in Table 1:
Drug AM Dose PM Dose Hydroxychloroquine 200mg 200mg Vitamin C 3000mg Vitamin D 30001U
Zinc 50mg Table I
100361 Optionally, the method of prevention can comprise administering on day 2: 3,000 mg of vitamin C; 3,000 IU of vitamin D; and 50 mg of zinc.
100371 Hydrovchloroquine is administered only on day 1. The half-life of hydroxychloroquine is up to 32 days, thus treatment with this drug for one day should be sufficient. However, should the need to prevent the infection or disease last longer than 32 days, repeat dosing can be considered. Accordingly, if necessary, the cycle of day 1 followed by day 2 can be repeated weekly, every 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, or 8 weeks.
100381 Vitamin C is administered at 3,000 rr12 per day ongoing. This 3,000 mg can be broken up into two 1500 mg doses, one taken in the morning and one taken at night.
100391 Vitamin D is administered at 3,000 1U per day ongoing. This 3,000 TU
can be broken up into two 1500 1U doses, one taken in the morning and one taken at night.

100401 Zinc is administered at 50 mg per day ongoing. This 50 mg can be broken up into two 25 mg doses, one taken in the morning and one taken at night.

Chloroquine or hydroxychloroquine can be administered in a daily dosage range of 20 mg to 2,000 mg. The above amounts recited in the tables are not limiting.
100421 Vitamin C can be administered in a daily dosage range of 250 mg to 10,000ing.
The above amounts recited in the tables are not limiting.
100431 Vitamin D can be administered in a daily dosage rage of 1,000 IIJ to 100,000 TU.
The above amounts recited in the tables are not limiting.
100441 Zinc can be administered in a daily dosage of 5 mg to 100 mg. The amount of Zinc can be reduced to 25 mg per day if gastrointestinal upset occurs.
100451 Zinc, Vitamin C and D help in numerous aspects of viral protection through cellular metabolism, including catalytic activity of enzymes, and play roles in immune function, protein synthesis.
100461 The chloroquine or hydroxychloroquine can come in various forms: as a pill, liquid solution, lozenges, topical treatment such as a cream. or oil, or any other means of delivery. Hydroxychloroquine prevents cytokine release, and cytokine release is what causes anaphylactic flush. Optionally, the hydroxychloroquine is sprayed directly on the users tongue.
100471 In a second embodiment, the present invention is directed to a second method of prevention that comprises administering three different supplements comprising vitamin C, vitamin D. and zinc, and mixtures thereof, to an individual.

Referring now to Figure 2, there is shown the second method of prevention. The length of preventative treatment of the present invention can be as long as necessary.
However, regardless of the length of treatment, Vitamin C is provided at 10,000mg daily for the first three days of treatment, and then 3000mg daily thereafter. This 10,000 mg of Vitamin C can be broken up into two doses, one taken in the morning and one taken at night.
100491 Vitamin D is provided at 40,000 1U one day every 4 weeks (or however many weeks the preventative treatment lasts). This 40,000 IU of Vitamin D can be broken up into two doses, one taken in the morning and one taken at night.
100501 Zinc is provided at 50mg per day ongoing, for the length of the preventative treatment. This 50 mg of Zinc can be broken up into two doses, one taken in the morning and one taken at night.
10051.1 On Day I (Week 1), the patient provides verbal informed consent, the patient reviews prior (previous 3 months) and concomitant medications and the patient receives the three different supplements: Vitamin C, Vitamin D, and Zinc. The patient takes 10,000 mg of Vitamin C, 40,000 III of Vitamin D, and 50 mg of zinc.
100521 On Days 2 and 3 (Week 1), the patient takes 10,000 mg of Vitamin C
and 50 mg of zinc daily. This 3,000 rr12 can be broken up into two 1500 mg doses, one taken in the morning and one taken at night. The patient is called on the phone for assessment for potential adverse events (AE) and serious adverse events (SAE), and any COVID-symptoms.
100531 On Days 4-7 (Week 1), the patient takes 3,000 mg of Vitamin C and 50 mg of zinc daily.
100541 On Day 8 (Week 2), the patient takes 3,000 mg of Vitamin C, 40,000 IU of Vitamin D, and 50 mg of zinc.
100551 On Days 9-14 (Week 2), the patient takes 3,000 mg of Vitamin C and 50 mg of zinc daily.
100561 Weeks 3-24 continue with the same protocol identified above for Week 2.

Treatment can be for one day or consecutive or repeated in 2 weeks, 1 month, 6 months or 1 year.
10058]
Optionally, Vitamin C dosage can range from 1000mg to 10,000mg per day, Vitamin D dosage can range from 1000 IU to 40000 IU per day, Zinc (the zinc can be any type or form of zinc) dosage can range from 25-75 mg per day. As noted above, all daily doses of Vitamin C, Vitamin D and Zinc can be broken up into two daily doses, wherein one dose is taken in the morning and one dose is taken in the evening. For all protocols provided in this application, when a dosage range is provided, any dosage amount that is included in that range can be administered. Accordingly, the invention is not limited to the dosage ranges disclosed, and includes all dosage amounts contained in those ranges.
100591 The protocols provided in this application can also include selenium, copper and other vitamins that are deemed appropriate supplements for Vitamin C, Vitamin D or Zinc or, to counteract the negative depletion of certain vitamins, like copper or selenium.
100601 The Vitamin C, Vitamin D and Zinc, and mixtures thereof, can be administered orally, in the form. pills/lozenges, an aerosolized spray, or a food substance such as a liquid drink or yogurt composition. Optionally, the Vitamin C. Vitamin D and Zinc can be administered in the form. of a nasal spray or a topical application, such a lotion or spray for administration on the individual's skin.
100611 In the methods of prevention described above, all, or any combination of, the antimicrobials/supplements disclosed above can be administered in the form of a single small atomizer. The patient sprays the atomizer towards the back of their throat.
The spray is administered at least once a day, but preferably twice a day when coughing starts. Use of the atomizer continues as directed by the supervising physician.
100621 In a second embodiment, the present invention is directed to a first method of treating an individual with infection or disease with five different antimicrobials. The five antimicrobials comprise: hydroxychloroquine, azithromõ,cin, vitamin C. vitamin D and zinc.
Referring now to Figure 3, there is shown the first method of treatment.
100631 Day 1 following positive test (isolation), the individual takes the following regimen outlined in Table 2:
Drug AM Dose PM Dose Hydroxychloroquine 200mg 200mg Azithromycin 500mg Vitamin C 3000mg Vitamin D 30001U
Zinc 50mg Table 2 100641 On Day 2-Day 5 the individual takes the following regimen outlined in Table 3:
Drug AM Dose PM Dose Hydroxychloroquine 200mg 200mg Azithromycin 25 Otno Vitamin C 3000mg Vitamin D 30001U
Zinc 50mg Table 3 100651 On Day 6-Day 10, the individual takes the following regimen outlined in Table 4:
Drug AM Dose PM Dose Hydroxychloroquine 200mg 200mg Vitamin C 3000 mg Vitamin D 3000W
Zinc 50mg Table 4 /00661 Hydroxychloroquine is administered daily, at 200 mg twice daily for days 1-10.
100671 Azithromycin is administered daily, at 500 mg on day 1, and 250 mg days 2-5.
Optionally, azithromycin can be administered at 250 mg per day for 5-10 days with a loading dose of 500 mg x day 1 or simply 250 mg on day 1. Azithromycin may be substituted with doxycycline at a daily dosage range of 25 mg to 800 mg, for those unable to take azithromycin. Alternatively, minocycline or antibiotics that inhibit bacterial 50S ribosomal RNA, and mixtures thereof, may be used.
100681 Optionally, natural products like quercetin and artemesia, and mixtures thereof, may be used, as well as any natural compounds that are used to make hydroxychloroquine or azithromycin, and mixtures thereof Accordingly, any mixture of any of the above recited compositions may be used.
100691 Vitamin C is administered at 3,000 mg per day ongoing. This 3,000 mg can be broken up into two 1500 mg doses, one taken in the morning and one taken at night.
100701 Vitamin D is administered at 3,000 1U per day ongoing. This 3,000 TU
can be broken up into two 15001U doses, one taken in the morning and one taken at night.
100711 Zinc is administered at 50 mg per day ongoing. This 50 mg can be broken up into two 25 mg doses, one taken in the morning and one taken at night.
100721 Chloroquine or hydroxychloroquine can be administered in a daily dosage range of 20 mg to 2,000 mg. The above amounts recited in the tables are not limiting. The chloroquine or hydroxychloroquine can come in various forms: as a pill, liquid solution, lozenges, topical treatment such as a cream or oil, or any other means of delivery.
Hydroxychloroquine prevents cytokine release, and cytoldne release is what causes anaphylactic flush. Optionally, the hydroxychloroquine is sprayed directly on the users tongue.
100731 Vitamin C can be administered in a daily dosage range of 250 mg to 10,000mg.
The above amounts recited in the tables are not limiting.
100741 Vitamin D can be administered in a daily dosage rage of 1,000 IU to 100,000 IU.
The above amounts recited in the tables are not limiting.
100751 Zinc can be administered in a daily dosage of 5 mg to 100 mg. The amount of Zinc can be reduced to 25 mg per day if gastrointestinal upset occurs.

Concurrently with the above treatment, the individual is self-quarantined per CDC
recommendations.

Optionally, for the method of treatment noted above, as the dosages of the hydroxychloroquine, vitamin C, vitamin D and zinc remain the same throughout treatment;
all four of those antimicrobials can be administered in the form of a single small atomizer.
The patient sprays the atomizer towards the back of their throat. The spray is administered at least once a day, but preferably twice a day when coughing starts. Use of the atomizer continues as directed by the supervising physician.
100781 For all protocols provided in this application, vitamin C dosage can range from 250 mg to 10,000 mg per day, vitamin D dosage can range from 1000 1U (mg) to 100,000 IU
(mg) per day, zinc (which can be any form or type of zinc) dosage can range from 5 mg to 100 In2 per day, and hydroxychloroquine dosage can range from 50 mg to 2,000 mg per day for a treatment period of 1 to 10 days treatment. Optionally, hydroxychloroquine can be administered once as single dose. For all protocols provided in this application, when a dosage range is provided, any dosage amount that is included in that range can be administered. Accordingly, the invention is not limited to the dosage ranges disclosed, and includes all dosage amounts contained in those ranges.

Optionally, the above protocols can include selenium, copper and other vitamins that are deemed acceptable supplements for vitamin C, vitamin D or zinc or to counteract the negative depletion of certain vitamins, which is why copper or selenium are typically used.

Treatment can be for one day or consecutive or repeated in 2 weeks, 1 month, 6 months or 1 year, or weekly for 6 months.
100811 In a third embodiment, the present invention is directed to a second method of treating COVID-19 infection. Referring now to Figure 4, there is shown the second method or treat ment 100821 The ivermectin can either be administered while the patient is undergoing the first method of treatment discussed above, or after the patient has undergone
5 to 7 days of the treatment of the method of treatment discussed above.
100831 The dosage amount for the ivermectin is 12-18 mg/day. The ivermectin can be administered daily, for up to 10 consecutive days, or alternatively, the ivermectin can be administered on day 1, day 3/day 4 and day 7/day 8 of a 10 day period. The 10 day period can either be in conjunction with administration of the treatment of the first method of treatment discussed above, or following the completion of the 5 to 7 days of treatment with the first method of treatment discussed above.

ivermectin can be administered in a pill/tablet, a nasal spray, an oral spray, or a topical ointment.

Optionally, natural products as well as any natural compounds, and mixtures thereof that are used to make ivermectin may be used as an alternative to ivermectin.

100861 Optionally, either the first or the second methods of treating COV1D-19 infection can also include administering doxycycline (or any other alternatives listed above and mixtures thereof) to the patient in a dosage amount of 200 mg, by mouth, twice a day, for up to 10 consecutive days.
10087] Accordingly, combining the first and second methods of treatment discussed above can result in a combined method of treatment that can include the use of hydroxychloroquine, azithromycin, ivermectin, doxycycline, vitamin C, vitamin D and zinc, taken all at the same time.
10088] The above protocols can be used to prevent and treat other viruses (not just COVID-19), including other flu and various respiratory viruses, including more benign coronaviruses and tfinovinises.
100891 The above protocols can also be used to prevent and treat Autism, Parkinson's, Alzheimer's and other neurological diseases.

100911 Example 1: Hydroxychloroquine, Vitamin C. Vitamin D. and Zinc for Prevention of CM/ 19 Infection 100921 Objective: To determine whether treatment with hydroxychloroquine, vitamin C, vitamin D, and zinc in combination will prevent infection with COVID-19 and to assess the safety and tolerability of hydroxychloroquine, vitamin C, vitamin D, and zinc in healthy, high-risk individuals without hypertension, and no evidence of COVID-19 infection.
100931 Procedure: Day 1: Prescription of study drugs and home health monitoring equipment. The study drugs are hydroxychloroquine 200mg twice a day for 1 day only, vitamin C 3000mg per day ongoing, vitamin D 3000mg per day ongoing, and zinc 50mg per day ongoing per day. The home health monitoring equipment is an electrocardiogram (EKG) which synchs up with a smartphone 100941 Days 2-7: Patient collects the EKG once during this week using the home health equipment 10095] Weeks 1-23: Patient provides an assessment of any COV1D-19 symptoms and continues to collect EKG weekly throughout the remainder of the trial 100961 Week 24: Patient undergoes confirmatoiy COV1D-19 testing which consists of nasopharyngeal (NP) and oropharyngeal (OP) swabs collected according to CDC
(Center for Disease Control) protocol. The swabs consist of synthetic fiber swabs with plastic shafts. NP
swabs are collected by insertion of a swab into the nostril parallel to the palate. The swab is left in place a few seconds to allow it to absorb secretions. OP swabs are inserted into the oropharynx parallel to the palate, avoiding the tongue. The swab is left in place a few seconds to allow it to absorb secretions. The swabs are then immediately placed in sterile tubes with 2-3mL of viral transport media. The tubes are placed in biohazard bags then boxes and couriered to the local Public Health Lab.
100971 Table 5 provides a schedule of events for Example 1.
Screening Weeks Week Assessment Day 3 (Day 1) 1-23 24 Informed consent and demographics X
Review of prior and concomitant medications X
EKG at home X X
Prescription of Flydroxychloroquine, vitamin C, vitamin X
D. and zinc Provision of home health EKG and pulse oximeter X

Update list of prior and concomitant medications X X X
Ask about any adverse events and any serious adverse X
events Evaluation of COVID-19 symptoms X X
COV I D-19 testingX
X
Blood draw for future testing Vitals in-clinic X
Physical exam X
Table 5 Regarding Table 5: Vitals at home to include EK.G and 02Sat, future testing will require separate informed consent and could possibly include antibody or cytokine testing, and vitals in-clinic to include height, weight, blood pressure (following 5 minutes sitting) pulse, respiratory rate, temperature, and oxygen saturation.

Example 2: Randomized. Double-Blind. Placebo-Controlled Phase 11.A. Study of Hydroxychloroquine. Vitamin C. Vitamin D. and Zinc for the Prevention of COVID-Infection Objectives: Prevention of COV1D-19, Lack of COV1D-19 symptoms, and assessment of safety and tolerability Procedure: Screening Period (Days -5 to -1): Prescription of home health monitoring equipment that includes a thermometer, a pregnancy test if applicable, and a daily diary. There are two groups being studied: Arm 1 and Arm 2.
1001021 Arm 1 is prescribed the following antimicrobials: hydroxychloroquine 200mg twice a day for 1 day only, vitamin C 30001U per day for 12 weeks, vitamin D
30001U per day for 12 weeks, and zinc 50mg per day for 12 weeks. The zinc can be reduced to 25 mg if GI upset occurs.
1001031 Arm 2 is prescribed the following antimicrobials: Placebo twice a day for 1 day only, vitamin C 30001U per day for 12 weeks, vitamin D 3000IU per day for 12 weeks, and zinc 50mg per day for 12 weeks. The zinc can be reduced to 25 mg if GI upset occurs.
1001041 Day 1:
Patient is called to teach them how to use the diary in the EDC, discuss the medication regimen, and answer any questions they may have. Patient takes pregnancy test if applicable, collects a temperature reading, completes their diary, and takes the prescribed treatment regimen. Table 6 outlines the prescribed treatment regimen for Day 1.
Drug AM Dose PM Dose Hydroxychloroquine (or placebo) 200mg 200rng Vitamin C 3000mg Vitamin D 30001U
Zinc 50mg Table 6 1001051 Day 2:
Patient collects a temperature reading, completes their diary, and is called on the phone for assessment of any adverse events or serious adverse events, assessment of any COV1D-19 symptoms, the list of prior and concomitant medications is updated, any questions the patient has are answered, and the patient takes their prescribed treatment regimen. Table 7 outlines the prescribed treatment regimen for Day 2.
Drug AM Dose PM Dose Vitamin C 3000mg Vitamin D 3000W

Zinc 0mg Table 7 1001061 Days 3-10: Patient collects a temperature reading, completes their diary, and takes their prescribed treatment regimen. Table 8 outlines the prescribed treatment regimen for Days 3-10.
Drug AM Dose PM Dose Vitamin C 3000mg Vitamin D 30001U

Zinc 0mg Table 8 1001071 Day 14:
The patient is called for instruction on how to collect a nasal swab and package for shipping, assessment COVID-19 symptoms, updating their list of prior and concomitant medications, and answering any questions they may have.
100108j Weeks 3-11: The patient is called weekly for assessment of any adverse events or serious adverse events, assessment of any COVID-19 symptoms, updating their list of prior and concomitant medications, and answering any questions they may have. The patient takes weekly temperature readings, completes their diary, and takes the prescribed treatment regimen During Week 4 the patient is reminded to collect a nasal swab. The prescribed treatment regimen for Weeks 3-11 is shown in Table 9.
Drug AM Dose PM Dose 3000111g Vitamin C
Vitamin D 3000 1U

Zinc 0mg Table 9 1001091 Week 12: The patient presents to the clinic for evaluation that includes assessment for adverse events and serious adverse events, updating their list of prior and concomitant medications, a physical exam, nasal swab collection and COV1D-19 sample collection.
1001101 Samples for COV1D-19 testing are collected using synthetic swabs with plastic shafts. Nasal swabs are collected and immediately placed into a sterile vial with 2-3 mL of viral transport media. The vials are placed into biohazard bags, boxed up, the box sterilized, and picked up for shipment to the central laboratory. Samples are tested by RT-PCR.
1001111 Table 10 presents the schedule of events for Example 2.
tko tql tf) 5 (4 A 7 j = = = e . = :1 fr3 41t Assessment Informed Consent & Demographics X
Initial Review of Prior and Concomitant Medications X
Medical Records review, including baseline EKG X
Randomization X
Prescription of Hydroxychloroquine or placebo.
X
vitamin C, vitamin D. and zinc Provision of daily diary, thermometer and pregnancy X
test Pregnancy Test if applicable X
Temperature at home X X X X X X X X
Complete daily diary X X X X X X X X
Hydroxychloroquine 200ing X
Vitamin C 3000mg X X X X X X X X
Vitamin D 3000 It) X X X X X X X X
Zinc 50mga .X.X.X.X.X.X.X X
Phone/video call to patientb X X X X X X X
Update list of prior and concomitant medications X X X X X X X X
Ask about AE arid SAE X X X X X X X X
Assessment of COVID-I9 symptoms X X X X X X X X

Swabs for RT-PCR X X X
Vitals in.-clinic` X
Physical Exam X
Table 10 1001.121 Regarding Table 10: The Zinc may be reduced to 25mg if GI upset occurs, phone/video calls to the patient occur weekly during Weeks 2-11, and vitals in-clinic include height, weight, blood pressure (following 5 minutes sitting) pulse, respiratory rate, temperature, and oxygen saturation.

Statistical Analysis: The treated patients in this study are compared to the placebo group. Measurements include PCR test results, presence or absence of symptoms, and symptom severity.
1001141 The change of these measurements from the end to the baseline (post¨pre) are used as the primary outcome, for example, lie = ¨ tie , where ttel and 1.te0 are the outcome of patients from the treatment group at the end and at baseline, respectively.
1001151 Ho A<150 against 11õ A> 80 where 80 is a clinically meaningful threshold to measure the disease symptoms. In this study, that meaningful threshold is calculated as mean change in clinical symptoms as recorded in the diary, from baseline through week 12. Each category' in the diary is assigned a number. 0 for None, 1 for Mild, 2 for Moderate and 3 for severe. Each category is analyzed independently and as a group.

Categorical variables are summarized by presenting the number (n) and percent (%) of subjects in each category. All Statistical tests for the analysis are performed using the p<0.05 level of significance. All confidence intervals are one-sided.
1001171 Since these are healthcare workers who are exposed to COVID-19 at every shift, efficacy is determined by RT-PCR testing, as well as the presence or absence of symptoms as recorded in the patient diary via EDC.

1001181 Example 3: Use of Hydroxychloroquine, Azithromvcin, Vitamin C.
Vitamin D.
and Zinc to treat COVID-19 Infection (HAZDPAC) 1001191 Objectives: test the efficacy of hydroxychloroquine, azithromycin, vitamin C, vitamin D, and zinc in the treatment of patients with COVID-19 infection and to assess the safety and tolerability of this treatment in patients with COVID-19 infection.
1001201 Procedure: First, the patient is determined to have COVID-19.
1001211 Day 1 following positive test (isolation): The patient takes prescribed regimen outlined in Table 11.
Drug AM Dose PM Dose Hydroxychloroquine 200mg 200mg Azithromycin 500ing Vitamin C 3000mg Vitamin D 30001U
Zinc 50mg Table 11 1001221 Day 2-Day 5: The patient takes the prescribed regimen outlined in Table 12.
Drug AM Dose PM Dose Hydroxõ,chloroquine 200mg 200mg Azithromycin 250mg Vitamin C 3000mg Vitamin D 3000IU
Zinc 50mg Table 12 1001231 Day 6-Day10: The patient takes the prescribed regimen outlined in Table 13, Drug AM Dose PM Dose Hydroxychloroquine 200m 200mg Vitamin C 3000m2 Vitamin D 3000W
Zinc 50mg -----------------------Table 13 1001241 Follow-Up Period: Month 1 (outpatient only AFTER negative test):
vital signs are taken that include blood pressure, heart rate, respiratory rate, oxygen saturation, temperature), the patient is assessed for adverse events and serious adverse events, and swabs for PCR are taken.
1001251 Month 3 (outpatient): vital signs are taken that include blood pressure, heart rate, respiratory rate, oxygen saturation, temperature), the patient is assessed for adverse events and serious adverse events, and swabs for PCR are taken.
1001261 Month 6 (outpatient) vital signs are taken that includes blood pressure, heart rate, respiratory rate, oxygen saturation, temperature), the patient is assessed for adverse events and serious adverse events, and swabs for PCR are taken.
1001271 Month 9 (outpatient) vital signs are taken that includes blood pressure, heart rate, respiratory rate, oxygen saturation, temperature), the patient is assessed for adverse events and serious adverse events, and swabs for PCR are taken.
1001281 Month 12 (outpatient) vital signs are taken that includes blood pressure, heart rate, respiratory rate, oxygen saturation, temperature), the patient is assessed for adverse events and serious adverse events, and swabs for PCR are taken.

sample collection procedure is as follows: nasopharyngeal (NP) and orophwyngeal (OP) swabs are collected according to CDC protocol. The swabs comprise synthetic fiber swabs with plastic shafts. NP swabs are collected by insertion of a swab into the nostril parallel to the palate. The swab is left in place a few seconds to allow it to absorb secretions. OP swabs are inserted into the oropharynx parallel to the palate, avoiding the tongue. The swab is left in place a few seconds to allow it to absorb secretions. NP and OP
swabs are immediately placed in sterile tubes with 2-3mL of viral transport media. The tubes are placed in biohazard bags then boxes and couriered to the local Public Health Lab. Table 14 outlines the schedule of events for Example 3.

Table 14 CI-C3-' CI.C7 Ent En Ent Ent -H
+1 +1 +1 +1 .nrE
r-1 C.0 01 n¨E
-;:c C 4.4 4.4 a+
"40 0.0 .= C C C C
Assessment 0 0 0 o aa a 2 2 2 2 2 Informed Consent & Demographics X
Confirmation of Positive PCR for X

Review of Medical Records X
Vitals X X X X X
Prescription of Antimicrobialsb X
Ask about AE and SAE X X X X X X
1001301 Regarding Table 14: Vitals to include height (only at first visit), weight, blood pressure (following 5 minutes sitting) pulse, respiratoly rate, temperature;
and oxygen saturation. Dosage to be given as in section 8, below 1001311 Table 15 provides a summary of the antimicrobial dosage of Example 3.
Treatment Method Medication Dose Frequency Hydroxychloroguine Ming BID
=
Azithromycin 500mg \Day 14250mg Day 2-5 Daily =
Quintuple Therapy Vitamin C 3 000rog Daily Vitamin D 500011.3 Daily Zinc 50mg Daily Table 15 1001321 Example 4: Randomized. Double-Blind, Placebo-Controlled Phase 11A
Study of Hvdroxychloroquine, Azithronwcin. Vitamin C. Vitamin D. and Zinc to treat Infection 1001331 Objectives: Test the efficacy of hydroxychloroquine, azithromycin, vitamin C, vitamin D, and zinc in the treatment of patients with COVID-19 infection and to assess the safety and tolerability of this treatment in patients with COVID-19 infection.
1001341 Procedure: First, the patient's diagnosis of COVID-19 infection is confirmed.

1001351 Screening Period (Days -3 to -1): Prescription of home health monitoring equipment that includes a thermometer, a pulse oximeter, a pregnancy test if applicable, and a daily diary. There are two groups being studied: Arm 1 and Arm 2.
1001361 Arm 1 is prescribed the following antimicrobials:
Hydroxychloroquine 200MG
BID for 10 days; Azithromycin 500mg on day 1, 250mg day 2-5; Vitamin C 30001U
for 10 days, then 1500mg for 20 days; Vitamin D 3000IU for 10 days, then 15001U for 20 days;
and Zinc 50mg for 10 days, then 25mg for 20 days.
1001371 Arm 2 is prescribed the following antimicrobials: Placebo for Hydroxychloroquine BID for 10 days; Placebo for Azithromycin to be taken 2 the on Day 1, then 1 on Days 2-5; Vitamin C 3000mg for 10 days, then 1500mg for 20 days;
Vitamin D
30001U for 10 days, then 15001U for 20 days; and Zinc 50mg for 10 days, then 25mg for 20 days. Table 16 outlines the prescribed antimicrobials discussed above.
Treatment Medication Dose Frequency Method Hydroxychloroquine 200ing BID
Azithromycin 500ing \Day 14250mg Day 2-5 Daily Quintuple Vitamin C 3000mg 4- Daily Therapy Vitamin D 50001U I Daily Zinc 50mg i Daily Placebo I tablet BID
Placebo 2 tablets day 1, then 1 tablet day Dail Placebo Vitamin C 3000mg Vitamin D 3000 1U Daily Zinc 50ing Daily Table 16 Treatment Period: Day 1 following positive test (isolation), the patient is video called to ensure they have all study materials and the following is discussed:
Use of home health equipment. Subject will take baseline measurements at this time and record it in the diary. Diary and how to transmit its contents, Medication dosing, Subject will take pregnancy test if applicable, Subject will use provided equipment to measure vital signs such as EKG, Oxygen Saturation, and Temperature. The patient takes prescribed regimen outlined in Table 17.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg 500mg ---Azithromycin (or Placebo) ¨
Vitamin C 3000me ---Vitamin D 3000W
Zinc 0mg Table 17 1001391 Day 2:
The patient completes the AM and PM diary entries, the patient uses the provided equipment to measure vital signs such as EKG, Oxygen saturation, and temperature, and the patient takes the prescribed regimen outlined in Table 18.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Azithromycin (or Placebo) 250mo Vitamin C 3000mg ---Vitamin D 30001U ---Zinc 5 0 ml?, Table 18 [001.401 Day 3:
The patient is called and asked if they are experiencing any difficulties with swab collection, whether there have been any adverse events and/or serious adverse events, the list of prior and concomitant medications is updated, the patient is asked about symptom resolution or progression, the patient is instructed on how to collect nasal swabs, and the patient then collects the first nasal swab. The patient completes their AM and PM
diary entries, and collects their vital signs such as EKG, oxygen saturation and temperature.
The patient takes the prescribed regimen outlined in Table 19.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Azithromycin (or Placebo) 250mg ---Vitamin C 3000mg Vitamin D 30001U ¨
Zinc 50mg Table 19 1001411 Day 4:
The patient completes their AM and PM diary entries, collects their vital signs, and takes the prescribed regimen outlined in Table 20.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg ¨
Azithromycin (or Placebo) 250mg 3000mo ---Vitamin C
---Vitamin D 30001U
Zinc 0mg Table 20 1001421 Day 5:
The patient completes their AM and PM diary entries, collects their vital signs, collects a nasal swab, and takes the prescribed regimen outlined in Table 21.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Azithromycin (or Placebo) 250mg Vitamin C 3000mg ¨
Vitamin D 30001U ¨
Zinc 50mg Table 21 1001431 Day 6:
The patient completes their AM and PM diary entries, collects their vital signs, and takes the prescribed regimen outlined in Table 22.

Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg ¨
Vitamin C 3000mg Vitamin D
Zinc 0mg Table 22 100144j Day 7: The patient is called and asked whether there have been any adverse events and/or serious adverse events, the list of prior and concomitant medications is updated, the patient is asked about symptom resolution or progression, and the patient then collects a nasal swab. The patient also completes their AM and PM diary entries and collects their vital signs. The patient takes the prescribed regimen outlined in Table 23.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Vitamin C 3000m2 ---Vitamin D

Zinc 0mg Table 23 1001451 Day 8:
The patient completes their AM and PM diary entries, collects their vital signs, and takes the prescribed regimen outlined in Table 24.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg 3000mg ---Vitamin C
300011.1 ---Vitamin D
Zinc 0mg Table 24 1001461 Day 9:
The patient completes their AM and PM diary entries, collects their vital signs, and takes the prescribed regimen outlined in Table 25.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Vitamin C 3000mv. ¨
Vitamin D 30001U ---Zinc 50ing Table 25 1001471 Day 10:
The patient is called reminded to decrease dosage of vitamins C, vitamin D, and zinc tomorrow. The patient is asked whether there have been any adverse events and/or serious adverse events, the list of prior and concomitant medications is updated, and the patient is asked about symptom resolution or progression. The patient also completes their AM and PM diary entries and collects their vital signs. The patient takes the prescribed regimen outlined in Table 26.
Drug AM Dose PM Dose Hydroxychloroquine (or Placebo) 200mg 200mg Vitamin C 3000mg Vitamin D 30001U ---Zinc 50mg Table 26 1001481 Day 11 to Day 13: The patient completes their AM and PM diary entries and takes the prescribed regimen outlined in Table 27.
Drug AM Dose PM Dose Vitamin C 1500mg ---Vitamin D 15001U ¨
Zinc 25mg Table 27 1001491 Day 14:
The patient is called and asked whether there have been any adverse events and/or serious adverse events, the patient is asked about symptom resolution or progression, and the patient then collects a nasal swab. The patient also completes their AM
and PM diary entries and collects their vital signs. The patient takes the prescribed regimen outlined in Table 28.
Drug AM Dose PM Dose Vitamin C 1500mg Vitamin D 1500W

Zinc 5mg Table 28 1001501 Day 15 to Day 30: The patient completes their AM and PM diary entries and takes the prescribed regimen outlined in Table 29.
Drug AM Dose PM Dose Vitamin C 1500mg ¨
Vitamin D 15001U --Zinc Table 29 1001511 Follow-Up Period: Month 1 (outpatient only AFTER negative test): Vital signs are taken (BP, HR, RR, oxygen saturation, temperature), the patient is assessed for adverse events and/or serious adverse events, and EKG is administered as well as physical exam and a blood draw for CBC/Complete metabolic panel/C-Reactive Protein. The list of prior and concomitant medications is updated and a nasal swab is collected.
1001521 Month 2 (outpatient): Vital signs are collected (BP, HR, RR, oxygen saturation, temperature) the patient is assessed for adverse events and/or serious adverse events, and EKG is administered as well as physical exam and a blood draw for CBC/Complete metabolic panel/C-Reactive Protein. The list of prior and concomitant 'medications is updated.
1001531 Month 3 (outpatient): Vital signs are taken (BP, HR, RR, oxygen saturation, temperature), the patient is assessed for adverse events and/or serious adverse events, and EKG is administered as well as physical exam. and a blood draw for CBC/Complete metabolic panel/C-Reactive Protein. The list of prior and concomitant medications is updated and a nasal swab is collected.
100154j COVID-19 Sample Collection Procedure is the same as that outlined above in prior Examples. Table 30 outlines the schedule of events for Example 4.
=
Pe) ¨ .1! 1.1 =C
E 7- N 9:" !..`. 7. r E
ae as' as al ae ae aa' a as a' le g Assessment V) s===1 t CA CA t:4 CZ 1-s. 7 7 Informed Consent & X
Demographics Make list of x X X X
prior and X
concomitant medications Confirmation of Positive X
PCR for COW./ - 1 9 Review of Medical X
Records Prescription of Antimicrobials X
a Provide home health X
equipment' Pregnancy test' : X
Call Subject at X X X
X X
homed Vitals at home :X X X X X X X X X X
Subject will X x x x x x x x x complete x x x x x x AM/PM diary Hydroxychloro X X X X
quine 200ing X X X X X X
BED (or placebo Azithsoinycin X
500mg (2 tablets) once daily (or placebo) Azithromycin I
250mg (1 X X X X
tablet) once daily (or _placebo) Vitamin C X X X
3000mg (4 X X X X X X
capsules) once daily Vitamin D X X X
30001U(4 X X X X X X
capsules) once daily Zinc 50mg (4 X X
capsules) once X X X X X X X
daily Vitamin C X X X X X
1500mg (2 capsules) once daily õ
Vitamin D X X X'X X
15001U (2 capsules) once daily Zinc 25mg (2 X X X X X
capsules) once daily Ask about AE X X X X X
X X
and SAE
Vitals in- X X X
chine.
Physical exam X X X
EKG in-clinic ,X X X

Swabs for RI- X X X
X X X
PCR
Bloodworkg X X X
Review list of X X X X X X X
X X X x X XX x prior and X X X
concomitant medications Table 30 [001551 Regarding Table 30: The antimicrobials include hydroxychloroquine 200mg tablets (#20), azithromycin 250mg tablets (#6), vitamin C 750mg capsules (#80), vitamin D
7501U capsules (#80), zinc 12.5mg capsules (#80); the home health equipment includes an EKG (worn continuously), pulse oximeter, and thermometer; the pregnancy test is administered if the patient is a woman of childbearing potential; the patients are called at home to remind them to collect swabs for RT-PCT, ask about AE/SAE, ask about symptoms;
and answer any questions; the vitals taken at home include an EKG, oxygen saturation, and temperature; the vitals in-clinic include height (only at first visit), weight, blood pressure (following 5 minutes sitting) pulse, respiratory rate, temperature, and oxygen saturation; and the bloodwork includes CBC, Complete Metabolic Panel, and CRP (details in section 9 Sample Collection).
1001561 Statistical Analysis: The treated patients in this study are compared to the placebo group. Measurements include PCR test results, presence or absence of symptoms, and symptom severity. PCR results will be compared between the groups as positive or negative 1001571 In this study, the meaningful threshold is calculated as mean change in clinical symptoms as recorded in the diary, from Day 1 through week 12. Each category in the diary is assigned a number, 0 for None, 1 for Mild, 2 for Moderate and 3 for severe.
Each category is analyzed independently and as a group. Ultimately, efficacy is determined based upon reduction and/or progression of symptomatic days, reduction of symptom severity, as well as analysis of the subject's RT-PCR testing per protocol. These data are compared to an existing database of de-identified Subject data.
1001581 The change of these measurements from the end to the baseline (post¨pre) are used as the primary outcome, for example, lie = le1 ¨ po, where pc' and to are the outcome of Subjects from the treatment group at the end and at baseline, respectively.
1001591 Categorical variables are summarized by presenting the number (n) and percent (%) of subjects in each category. All Statistical tests for the analysis are performed using the p<0.05 level of significance. All confidence intervals will be one-sided 1001601 Sample size was calculated as follows:
n= log /3 log p 1001611 Where /3 = the probability of a Type II error 1001621 p = the proportion of the population NOT affected 1001631 The proportion of the population affected by COV1D-19 is 0.005 percent, thus 0.995 percent aren't affected 1001641 The probability of a type 11 error is 0.05 1001651 Thus:
1001661 log 0.050 1001671 log 0.995 1001681 n=597.647 1001691 A sample size of 600 was used.
1001701 Example 5: Successful Treatment of COVID-19 Infected Outpatients and Prophylaxis of Immediate Associates 1001711 Objective: to successfully treat COVID-19 infected outpatients and prophylaxis of immediate associates.
1001.721 Procedure: Prospective COVID-19 infected individuals were diagnosed using a Pangea DNA/RNA ShieldTm Collection Tube to obtain a nasopharyngeal swab and PCR +ve patients were entered into the study. They were immediately commenced on a 10 day course of Hydroxychloroquine (200 mg, twice a day, for 10 days), Azithromycin extended release (500mg on day 1, then 250 M2 a day for days 9-10), zinc (50mg a day for days 1-10), Vitamin D (3000IU a day for days 1-10) and Vitamin C (3000mg a day for days 1-10). Some individuals lived alone; otherwise immediate partners and family deemed to be most exposed were given a prophylactic which comprised hydrox,chloroquine 200 mg twice a day on day 1 only with Zinc, Vitamin C and Vitamin D for given at the same doses as above for days 1-10.
1001731 Results: In 11 families a total of 21 family members were identified to be PCR
COVID-19 positive index cases and were treated with the above treatment protocol while 22 exposed associates with negative PCR were given the above prophylaxis protocol. This is shown below in Table 31. All 21 index cases were cured of COVID-19 infection as judged by the repeat swab PCR on day 10 and accompanying symptom resolution. None of the highly exposed associates developed COVID-19 infection when retested on day 10 (day 14 in Family 10) in spite of close co-habitation with the infected index cases.
Table 31 documents the results from families that received a 10-day course of daily HCQ (200mg bd), AZ
extended release (500mg day1, then 250 mg), zinc (50mg), Vitamin D (3000IU) and Vitamin C (3000mg) Family Patient/s Age (years)- Comorbidities of the After treating with After treating treated sex of the patients HAZDPAC Cured/ ZINCD+II family patient PCR test member positivelneg,ative/ prophylaxed other symptoms #1 1 23 male Asthma Negative PCR ¨ day s Parents overweight, diabetes, father with heart disease never got the disease 3 60- male All 3 patients cured Mother didn't get (father) the virus 18- male (son) Asthma 16- female (daughter) 43 1 40-female Avoided intubation Sever multiple Husband did not by leaving hospital symptoms resolved turn positive at home #4 2 78- male BCG+COPD, Both cured Daughter, son-in-diabetes, heart law and 2 grandkids disease (heart didn't catch the surgery month prior virus 77- female Pacemaker, BCG
3 56-male Unable to eat or Started treatment on Wife never got the drink day 10, Sever disease symptoms resolved Cured 27- male 24- female Asthma fi6 1 56- female Admitted to hospital Husband never got ¨sent home, as two the disease kids were sick with fever. All recovered with vitamins 47 1 44-female Cured, autoimmune Husband and 4 kids issues started never got the disease #8 3 52- female Lupus Cured Boyfriend (My) with Diabetes, son 53- male Cured (18) and daughter 19- male Severe asthma Cured (16) never got the disease 419 2 45-female Both cured from Husband and severe symptoms of daughter never got 16-male cough and fever the disease #10 2 44- male Cured from loss of Mother (50y) never smell, fever, cough got the disease Cured 25-female Partially treated with 21-female HAZDPAC ¨ slowly turned - ve #11 1 33-female No ICU nurse recovered Boyfriend never got the disease Table 31 1001741 Apart from the families a further 11 single infected individuals found to be swab PCR positive were treated with the above treatment protocol. This is shown below in Table 32. All were also successfully cured of the infection.
Patient Age (years)- sex of the Comorbidities/symptoms of the After treating with patient patients HAZDPAC Cured/not #1 44-female (no BCG in Asthma Cured childhood) 81- male Diarrhea Cured fi3 52-female Fever Cured #4 66-male Valve surgery Cured #5 29-female (no 13CG in Asthma Cured childhood) #6 50-female Auto immune thyroiditis, sever Cured cough and fever #7 43-male Cough, desaturation of oxygen Cured #8 53-male Diarrhea, cough, fever. Cured desaturation of oxygen #9 44- female Autoimmune history, fever, Cured increase heart rate ii10 44- female Pneumothorax discharged from Cured ICU with COVID-19 #11 43- male Fever +ve Covid-19 PCR Cured Table 32 1001751 A further 9 individuals recently closely exposed to Covid-19 infected persons were given the prophylaxis protocol outlined above. The prophylactic worked very well with no exposed person acquiring the infection. This is shown in Table 33.
Individual Age (years) & details of the individual After treating with ZINCD-FH
41 Mother of 16 year old child who had Prophylaxed and never got the disease #7 24- female, ICU nurse ¨ multiple Prophylaxed and never got the disease exposures #3 47- male, cardiologist eNposed to +ye ProphylaNcd and never got the disease patients #4 70- male medical director of a hospital Prophylaxed and never got the disease (exposed to numerous doctors with COVID-19) #5 55- male anaesthesiologist (intubates Prophylaxed and never got the disease COVID-19 patients) #6 55- ICU nurse (worked on COV1D-19 Prophylaxed and never got the disease floor) #7 40- ICU nurse main' Covid-19 patients Prophylaxed and never got the disease #8 53-Doctor with pancreatitis Prophylaxed and never got the disease #9 28-Paramedic - healthy Prophylaxed and never got the disease Table 33 1001761 Discussion: It was demonstrated that a 10 day combination of hydroxychloroquine, azithromycin (for 5 days only), zinc with vitamin D and vitamin C, can result in uniform cure of COVID-19 infection when used in an outpatient population. The prophylaxis treatment noted above for those closely exposed to proven, infected patients can completely prevent spread of COVID-19. This combination of test-and-treat permits abolishing of new outbreaks of infection such as a 'next wave' - by avoiding quarantine to treat the infected and give prophylactics to surrounding staff and family.
1001771 In conclusion, this is an effective anti-Covid-19 therapy as well as an effective prophylactic combination capable of arresting the spread of coronavirus infection throughout the community. This is achieved by treating the index case and the surrounding associates of the patient as early as possible after infection is identified and then treating the people they live with and close associates.
1001781 Example 6: Presence of the SARS-CoV-2 by NGS of Fecal Samples 1001791 Objective: In view of the large percentage of SARS-CoV-2 detectible by RT-PCR in stools of infected patients, the objective was to identify the presence of the SARS-CoV-2 by NGS of fecal samples from symptomatic study participants positive for SARS-CoV-2 by nasopharyngeal sample RT-PCR, in addition to asymptomatic individuals (with or without prior nasopharyngeal sample RT-PCR). The objective was also to execute whole genome analysis to characterize SARS-CoV-2 mutational variations to identify potentially significant nucleotide changes.

1001801 Procedure: Study participants (n = 14) underwent testing for SARS-CoV-2 from fecal samples by whole genome enrichment NGS. Following fecal collection (Zymo Research Shield Fecal Collection Tubes), RNA was extracted (Qiagen Al!prep Power Viral Kit), reverse transcribed (New England Biolabs NEBNext 1st and 2nd Strand Synthesis Modules), library prepped (IIlumina Nextera Flex for Enrichment), enriched (Ilumina Respiratory Virus Oligo Panel), and sequenced on Illumina's NextSeq 550 System.
Sequences were then mapped to the SARS-CoV-2 Wuhan-Hu-1 (MN90847.3) complete genome utilizing One Codex's SARS-CoV-2 bioinformatics analysis pipeline. SARS-CoV-2 positive samples were further analyzed for mutational variants that differed from the reference genome. Of the 14 study participants, 12 also had their nasopharyngeal swabs tested for SARS-CoV-2 by RT-PCR.
1001811 Results:
The results from patients that had their stool samples tested by whole genome enrichment NGS, and their nasopharyngeal swabs tested by RT-PCR for the presence of SAR.S-CoV-2 were evaluated. Of the 14 study participants, ten were symptomatic and tested positive for SARS-CoV-2 by RT-PCR, two asymptomatic individuals tested negative, and two other asymptomatic individuals did not undergo RT-PCR
testing (Table 34). Patients 5 and 7, which tested positive by RT-PCR from nasopharyngeal swabs, were treated with the protocol from Example 5 above (Hydroxychloroquine, Azithromycin, vitamin C, vitamin D, and zinc for 10 days prior to fecal collection).
Similarly, after positive nasopharyngeal swab, patient 13 was treated with vitamin C, vitamin D, and zinc for 10 days (the same protocol as noted above in Example 5) before fecal collection. The concordance of SARS-CoV-2 detection by enrichment NGS from stools among positive non-treated patients tested by RT-PCR nasopharyngeal analysis was 100% (7/7). Patient 8, who did not undergo nasopharyngeal analysis, tested positive for SARS-CoV-2 by NGS. The three patients (5, 7, 13) that received treatment prior to providing fecal samples, all tested negative by NGS.

Asymptomatic patients 2 and 9, who tested negative by nasophary, ngeal swab, were also negative by NGS, as was asymptomatic patient 14. Table 34 outlines the symptoms and SARS-CoV-2 testing results.
- __________________________________________________________________ Nasophalyngeal Fecal Patient Sample ID Symptoms Swab (RT- Treated (NGS) Location PCR) Patient 1 febrile, diarrhea, anosmia, 02 sat. <90% + no + PA
Patient 3 febrile, diarrhea, 02 sat. <90% + no + CA
Patient 4 febrile, diarrhea, anosinia, 02 sat. <90% + RO + AZ
Patient 6 febrile. cough, anosmia + RO + AZ
Patient 8 none nia no 1- CA
---------------------------------- _ ..........
Patient 10 febrile, cough. headache + no + GA
Patient 11 febrile. cough, headache + RO + GA
Patient 12 febrile, cough -F. no + GA
Patient 5 febrile, cough + yes ¨ CA
Patient 7 febrile, cough + yes ¨ GA
Patient 13 febrile, cough + yes ¨ GA
Patient 2 none ¨ no ¨ CA
Patient 9 none ¨ no ¨ CA
Patient 14 none nia RO - CA
:
Table 34 100182j All fecal samples analyzed by enrichment NGS from positive patients by RT-PCR, achieved 100% genome coverage of SARS-CoV-2 except for patient 3 which had 45%, and patient 10 which had 93% coverage. Table 35 outlines the enrichment NGS
metrics.
Genome /4 Variants Mapped Sample ID Mean Depth Coverage (over 10x) Reads Patient 1 100% Ii 465645 1129.8x Patient 3 45% 11 5984 31.7x Patient 4 100% 9 131582 318.6x Patient 6 100% 10 793603 1924.6x Patient 8 100% 10 496852 1206.7 Patient 10 93% 9 5929 15.6x Patient ii 100% 10 1270734 3075.3x Patient 12 100% 10 38256 92.7x Table 35 /00183j The total number of SARS-CoV-2 mapped reads for patients 1, 3, 4, 6, 8, 10, 11, and 12 were 465645, 5984, 131582, 793603, 496852, 5929, 1270734, and 38256 respectively. The mean read depths of SARS-CoV-2 for patients 1, 3, 4, 6, 8, 10, 11, and 12 were 1129.8x, 31.7x, 318.6x, 1924.6x, 1206.7x, I5.5x, 3075.3x, and 92.7x, and respectively.
The read depths at specific coordinates along the SARS-CoV-2 genome for each patient are captured in Figures 5A-5H. Whole genome alignment of SARS-CoV-2 in patients 1, 3, 4, 6, 8, 10, 11, and 12 (respectively) as identified by One Codex's SARS-CoV-2 analysis pipeline.
The x-axis depicts the genornic coordinates as aligned to the MN908947.3 reference genome, and the y-axis represents the read depth at specific loci.
100184j Following alignment and mapping of SARS-CoV-2, patient genomes were compared to the Wuhan-Hu-1 (MN90847.3) SARS-CoV-2 reference genome via One Codex's bioinformatics pipeline to identify mutational variations. This analysis identified nucleotide variants at positions nt241 (C T) and nt23403 (A G) across all positive patients, and variants at positions nt3037 (C T) and nt25563 (G T) in seven of the eight patients (Table 3). Interestingly, patients 8, 11, and 12 harbored the same set of variants, as did patients 4 and 6 (who were kindred). Unique variants not identified in any of the other individuals were detected in patients 1, 3, 6, and 10, with patient 3 harboring the most distinct SARS-CoV-2 genome with eight unique variants, followed by patient 1 with seven.

Collectively, there were thirty-three different mutations among the patients in which SARS-CoV-2 was detected by whole genome enrichment NGS. Table 36 outlines the SARS-CoV-2 genomic positions, variant changes, and frequencies across the positive patient cohort.
Patient Patient Patient Patient Patient Patient Patient Patient Region (ORF) Posit iiin Valiant , ______________________________________________________________________ ' AAR 241 C ¨1 100% 100% 100% 100% 100%
100% 100% 100%
la 833 T ---, C x x x x 100% x 100% 100%
la 1059 C ¨, T x x 100% 100% 99% 100%
100% 100%
la 1758 C --i I x x 100% 100% x x x x ; a 1973 C ---, T x x x 87% x x x x la 3037 C ---. T 100% x 100% 100% 100%
100% 100% 100%
la 3078 C ---, T x 89% x x x x x x la 4866 ' G ---.. T 75% x x x x x x x la 6720 C ---, `I* 93% x x x x x x x la 8102 ' G ¨ I x 100% x x x x x x ' la 9401 ' 1 ---, C x x x x x 64% x x ' _ ______________________________________________________________________ la 9403 ' T ---> A x x x x x 64% x x ' la 10870 ' G --. T x x 100% 100% x x x x ' =
la 11123 G ¨0 A x x 100% 100% x x x x lb 14408 C ¨ T 100% x 100% 100% 100% x 100% 100%
lb 14877 C ¨0T x 100% x x x ____ x x x lb i 66 i 6 C ¨ T x x x x 100% x 100% 100%
lb 16848 C-1- 100% x x x x x x x lb 18652 C --- A x x x x x 83% x x ' I 0 19989 T ¨+ G x 100% x x x x x x Spike 21576 T ¨+ G x 83% x x x x x x Spike 23264 G --.0 A x 75% x x x x x x Spike 21403 A -- G 100% 100% 100% 100%
100 4 100% i 100% 100%
Spike 23603 C-1- 82% x x x x x I
x x 3a 25563 G --4 T x 100% 100% 100% 100%
100% ' 100% 100%

3a 25976 C ¨* A x x x x 100% x 100% 100%
27964 C ---. T x x x x 100% x 100% 100%
, Nucleoprotein - 28881 G ¨, A 100% x x x x x x x Nucleopiote in 28882 G ¨* A 100% x x x x x x x Nucleoprotein 28883 G ¨ C 100% x x x x x x x Nucleopiotein 28997 C ¨ T x 100% x x x X :
X X
Nucleoprotein 29019 A ¨ T x 100% X X X X X
X
_ Nucleoprotein 29364 C ¨, G x ' x x X X 85%
x x Table 36 Discussion: Although previous studies have identified SARS-CoV-2 in fecal collections by RT-PCR, this study was able to report whole genome sequencing (WGS) of SARS-CoV-2 from stool samples. SARS-CoV-2 was identified in patients that tested positive by nasopharyngeal swab RT-PCR analysis and unique genomes in 62.5% of the NGS
positive patients was observed. The overall homology among the genomes was high (99.97%), with variations identified in the ORF regions la, lb, S, 3a, 8, and N. Of particular interest, was the adenine to guanine change in the S protein at position nt23403 which converts aspartic acid to glycine (D ---- G).

Conclusion: Next generation sequencing identified the SARS-CoV-2 whole genome sequence in 100% of patients with positive nasopharyngeal RT-PCR and did not detect it in treated patients, or those with negative rt-PCR. These results highlight the importance of metagenomic analysis of the SARS-CoV-2 viral genome.

Example 7: Randomized. Double-Blind. Placebo-Controlled Phase IIA Study of Hydroxychloroquine, Vitamin C. Vitamin D. and Zinc for the Prevention of COVID-Infection Objectives: Prevention of COVID-19. Lack of COVID-19 symptoms, and assessment of safety and tolerability Procedure: Screening Period (Days -7 to -1): Prescription of home health monitoring equipment that includes a thermometer, a pregnancy test if applicable, and a daily diary. There are two groups being studied: Arm 1 and Arm 2.
1001901 Arm 1 is prescribed the following antimicrobials: hydroxychloroquine 200mg twice a day for 1 day only, vitamin C 30001U per day for 12 weeks, vitamin D
30001U per day for 12 weeks, and zinc 50mg per day for 12 weeks. The zinc can be reduced to 25 mg if GI upset occurs. The hydroxychloroquine is to be taken first thing in the morning as soon as subject has eaten and again right before bed, and must be separated from vitamin dose by at least 2 hours.
1001911 Arm 2 is prescribed the following antimicrobials: Placebo twice a day for 1 day only, vitamin C 30001U per day for 12 weeks, vitamin D 30001U per day for 12 weeks, and zinc 50mg per day for 12 weeks. The zinc can be reduced to 25 mg if GI upset occurs.
1001921 Day 1:
Patient is called to teach them how to use the diary in the EDC, discuss the medication regimen, and answer any questions they may have. Patient takes pregnancy test if applicable, collects a temperature reading, completes their diary, and takes the prescribed treatment regimen.. Table 37 outlines the prescribed treatment regimen for Day 1.
Drug AM Dose PM Dose Hydroxychloroquine (or placebo) 200mg 200mg Vitamin C 1500mg 1500m Vitamin D 1500IU 1500W
Zinc 25mg 25 mg Table 37 1001931 Day 2:
Patient collects a temperature reading, completes their diary, and is called on the phone for assessment of any adverse events or serious adverse events, assessment of any COV1D-19 symptoms, the list of prior and concomitant medications is updated, any questions the patient has are answered, and the patient takes their prescribed treatment regimen Table 38 outlines the prescribed treatment regimen for Day 2.
Drug AM Dose PM Dose Vitamin C 1500mg 1500mg Vitamin D 15001U 1500TU
Zinc -25mg 25mo Table 38 1001941 Days 3-10: Patient collects a temperature reading, completes their diary, and takes their prescribed treatment regimen. Table 39 outlines the prescribed treatment regimen for Days 3-10.
Drug AM Dose PM Dose Vitamin C 1500mg 1500mg Vitamin D 15001U 15001U
Zinc lcmo 25ing Table 39 1001951 Day 14:
The patient is called for instruction on how to collect a nasal swab and package for shipping, assessment COVID-19 symptoms, updating their list of prior and concomitant medications, and answering any questions they may have.
1001961 Week 3:
The patient is called for assessment of any adverse events or serious adverse events, assessment of any COVID-19 symptoms, updating their list of prior and concomitant medications, and answering any questions they may have. The patient takes a temperature reading, completes their diary, and takes the prescribed treatment regimen.

1001971 Table 40 outlines the treatment regime for week 3.
Drug AM Dose PM Dose Vitamin C 1500mg 1500mg Vitamin D 1500IU .15001U
Zinc 25mg 25mo Table 40 1001981 Week 4: The patient is called for assessment of any adverse events or serious adverse events, assessment of any COVID-19 symptom, updating their list of prior and concomitant medications, and answering any questions they may have. The patient takes a temperature reading, completes their diary, and takes the prescribed treatment regimen. The patient also collects a nasal swab.
1001991 Table 41 outlines the treatment regime for week 4.
Drug AM Dose PM Dose C 1500mg 1500mg Vitamin Vitamin D 1500IU 1500IU
Zinc =
25mg 1.5mo Table 41 1002001 Weeks 5-11: The patient is called weekly for assessment of any adverse events or serious adverse events, assessment of any COVID-19 symptoms, updating their list of prior and concomitant medications, and answering any questions they may have. The patient takes a weekly temperature readily, completes their diary, and takes the prescribed treatment regimen.
100201.1 Table 42 outlines the treatment regime for weeks 5-11.

Drug AM Dose PM Dose Vitamin C 1500mg 1500mg Vitamin D I 5001U I 500IU
Zinc 25mg 25mo Table 42 1002021 Week 12:
The patient presents to the clinic (or video conference) for evaluation that includes assessment for adverse events and serious adverse events, updating their list of prior and concomitant medications, a physical exam, nasal swab collection and sample collection.
1002031 Samples for COV1D-19 testing are collected using synthetic swabs with plastic shafts. Nasal swabs are collected and immediately placed into a sterile vial with 2-3 mL of viral transport media. The vials are placed into biohazard bags, boxed up, the box sterilized, and picked up for shipment to the central laboratory. Samples are tested by RT-PCR.
1002041 Table 43 presents the schedule of events for Example 7.
ci p.

RO
ri ==4 Cr 1.11 N 0 0 4 v4 Si 8 8 Assessment 8 8 Informed Consent & Demographics X
Initial Review of Prior and Concomitant Medications X s =
=
Medical Records review, including baseline EKG X
=
Randomization X
Prescription of Hydroxychloroquine or placebo, vitamin x C, vitamin D, and zinc Provision of daily diary, thermometer and pregnancy X
test Pregnancy Test if applicable X
Temperature at home X X X XX X XIX X X X X X X
Complete daily diary X X XXX X X X X X X X X X

Hydroxychloroquine 200mg Vitamin C 3000mg X X
XXX X X X X X X X X X
Vitamin D 30001U X X
XXX X X X X X X X X X
Zinc 50mr X X
XXX X X X X X X X X X
Phone/video call to patientb X X X XX X X X
X X X X X
Update list of prior and concomitant medications X X
XXX X X X X X X X X X
Ask about AE and SAE X X X
XX X XIX X X X X X X
Assessment of COVID-19 symptoms X X
XXX X X X X X X X X X
Swabs for RT-PCR X X X _ X
Vitals in-clinicc X
Physical Exam Table 43 Regarding Table 43: The Zinc may be reduced to 25mg if GI upset occurs, phone/video calls to the patient occur weekly during Weeks 2-11, and vitals in-clinic include height, weight, blood pressure (following 5 minutes sitting) pulse, respirator), rate, temperature, and oxygen saturation.

Statistical Analysis: The treated patients in this study are compared to the placebo group. Measurements include PCR test results, presence or absence of symptoms, and symptom severity.
1002071 The change of these measurements from the end to the baseline (post--pre) are used as the primary outcome, for example, ge = tel Ile , where gel and tte0 are the outcome of patients from the treatment group at the end and at baseline, respectively.
1002081 Ho 80 against H where tio where 50 is a clinically meaningful threshold to measure the disease symptoms. In this study, that meaningful threshold is calculated as mean change in clinical symptoms as recorded in the diary, from baseline through week 12. Each category in the diary is assigned a number, 0 for None, 1 for Mild, 2 for Moderate and 3 for severe. Each category is analyzed independently and as a group.

Categorical variables are summarized by presenting the number (n) and percent (%) of subjects in each category. All Statistical tests for the analysis are performed using the p<0.05 level of significance. All confidence intervals are one-sided.

1002101 Since these are healthcare workers who are exposed to COVID-19 at every shift, efficacy is determined by RT-PCR testing, as well as the presence or absence of symptoms as recorded in the patient diary via EDC.
1002111 Example 8: Method of Treating COVID-19 Infection with Ivermectin (Z1VERDOX) 1002121 A total of 6 patients infected with COVID-19 were treated as follows:
1002131 Day 1: 12-18 mg/day Ivermectin, 200 mg, Doxycycline twice a day, 10,000mg/ day Vitamin C, 1,000-100,000 Ili/day Vitamin D, and 5mg-100mg/day Zinc 1002141 Days 2 and 3: 200 mg Doxycycline twice a day, 250-10,000mg/ day Vitamin C, 1,000-100,000 IUlday Vitamin D, and 5mg-1.00mg/day Zinc 1002151 Day 4: 12-18 mg/day Ivermectin, Doxycycline, Vitamin C, Vitamin D, and Zinc [00216] Days 5, 6 and 7: 200 mg Doxycycline twice a day, 250-10,000mg/day Vitamin C, 1,000-100,000 IU/day Vitamin D, and 5ing-100ing/day Zinc 1002171 Day 8: 12-18 mg/day Ivermectin, Doxycycline, Vitamin C, Vitamin D, and Zinc 1002181 Days 9 and 10: 200 M2 Doxycycline twice a day, 250-10,000mg/ day Vitamin C, 1.000-100,000 IU/day Vitamin D, and 5mg-1.00mg/day Zinc 1002191 All 6 patients tested positive for COVID-19 antibodies at day 5 1002201 All 6 patients tested negative PCR at days 5-7.
1100221j Basic information about the 6 patients is shown in Table 44.
11fttiont No,hex gregm 5-ithrittiort iSirotoom:
...................... 95IM 92% Coq h, iever, shortness of bteatti, chOs ,, 44fi, 1Cmkgh, few, chMs ....................... lgoch!!!!!migtigtotimititi!!0!*tio4.0:601! ... !!!.
!!!
Table 44 1002221 Example 9: Study evaluating method of prevention (ZINCD+H) 1002231 As of January 14, 2021, a total of 91 individuals have been treated with the method of prevention of the claimed invention. These 91 individuals were high risk either from potential exposure at work or from living with people who had tested positive for COVID-19. Of those 91 individuals, 59 individuals gave consent for the test information to be released. Of those 59 individuals, 56 individuals had negative test results, two individuals had positive test results but were asymptomatic, and one individual had an invalid test result after receiving the prevention protocol.
1002241 In view of the above, it can be said that 58 out of the 59 individuals were successfully treated with the prevention protocol. That is a success rate of about 98%.
1002251 Table 45 details the information presented above. In Table 45, the results are color coded as follows:
h. Negative test results. are colored Light Grev c. There was only one invalid test result for PRG42-070 on I I/Id/2020 d. PCR tests that were not submitted are not coded.
PRG
Number ARIVI NOTE DAY 1 Day 14 MONTH 1 ARM

ARM

ARM
R A PRG42-003 7/1/2020 7/14/2020 7/:30/2020 9/28/2020 ARM

ARM
J k PRG42-005 ARM

2003 =
ARM

SCREEN

FAILURE

PRG
Number ARM NOTE DAY 1 Day 14 MONTH 1 SCREEN

FAILURE

SCREEN

FAILURE
ARM

NO

CONSENT
NO

CONSENT
ARM

AM

ARM

ARM

ARM

SCREEN

FAILURE

ARM

ARM

NO

CONSENT

NO

CONSENT

PRG
Number ARM NOTE DAY 1 Day 14 MONTH 1 MO1s1TH 3 CONSENT
V G PRG42-036 Duplicate CONSENT

A

ARNI m PRG42-040 8/31/2020 9/13/2020 9/29/2020 11/28/202 ARM

ARM P Cu PRG42-043 8/28/2020 9/10/2020 9/26/2020 11/25/202 NO

CONSENT
NO

CONSENT

CONSENT

AM

NO

CONSENT

ARM

NO

CONSENT

NO
s b PRG42-057 CONSENT
ARM
Z 1< PRG42-058 11/2/2020 11/15/2020 12/1/2020 1/24/2021 ARM

PRG
Number ARM NOTE DAY 1 Day 14 MONTH 1 ARM

J Cl PRG42-061 NO
CONSENT
ARM

ARM

ARM

NO

CONSENT
ARM
0 B PRG42-066 11/10/2020 11/23/2020 &v.,0 2/1/2021 1025 .1k" \
R M PRG42-067 Cu 6 WD 11/12/2020 ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

ARM

1034 \

PRG
Number ARM NOTE DAY 1 Day 14 MONTH 1 ARNI

M
S E PRG42-089 036 =12/25/12020. 1/7/2021 ARM

ARNI

Table 45 1002261 As shown above, the prevention protocol of the claimed invention is extremely effective.
1002271 Example 10: Study Evaluating Methods of Treatment and Prevention 1002281 In a second selection of studies, 25 different households/infection events were monitored/treated, where at least one person tested positive for COVID-19, and at least one housemate/family member/attendee was treated with a prevention protocol of the claimed invention. Specifically, there were 155 individuals total in the 25 households/events, with 75 of those 155 individuals testing positive for COVID-19, and the remaining 80 individuals were given at least one of the prevention protocols of the claimed invention.
1002291 The treatment protocol was TIAZDPAC Hydroxychloroquine, azithromycin, vitamin C, vitamin D and zinc administered as noted above in Example 3.
1002301 The prevention protocols included:
1002311 ZIVERDOX = Ivermectin, doxycyclin, vitamin C, vitamin D, and zinc administered as discussed above in Example 8.
1002321 ZINCD = zinc, vitamin C, and vitamin D administered as noted above.
1002331 ZINCD+H = zinc, vitamin C. vitamin D, and hydroxychloroquine administered as noted above.

1002341 Table 46 documents all of the data summarized above.
PCR
COVLD Ti or HAZ ZIVER ZINC ZINC ab Group Sex repeat 3 +/- Prophy DpaC DOX D D + H
months presence girl 4- Tx X negative positive Mom Neg Prophy X negative negative Dad Neg Prophy X negative negative boy -i- Tx X Ikegalive posithv girl -4-- Tx: negative tm&itive Mora Neg Prephy X negative negative NEEMMEMEMEN:MMEHMMMMMMMgMMEE:NEE:NEE:NEE:Nmagnmamm:::::mm::::i:,..
+ X negative positive Husband Neg Prophy X negative negative Kid I Neg Prophy X negative negative Kid 2 Neg Prophy X negative negative Malg + Tx X nggotim pMit, iNv Female 4. Tx: X negative tm&itive Daughter Neg 1.3tuti1ly X negative negative Son. M Law Neg Prot* X negative negative Kid I Neg Prephy X negative negative Neg Prophy V
...,. iteMjve. negative Male + Tx X negative positive 5 Daugheter + Tx X negative positive Son + Tx X negative positive Wife Neg Prophy negative negative X negative rframtrm 1-lit3biand Neg Prephy X negative negative ii Kid I X Bggaiim pMit, iNv Kki 2 .X n.,mi.l)ve poOti$v Female 4- Tx X negative positive Male Neg Prophy X negative negative 7 Kid I Neg Prophy X negative negative Kid 2 Neg Prophy X negative negative Kid 3 Neg Prophy X negative negative Kid 4 Neg Prophy X negative negative Male + Tx X negative positive ? F? + Tx X negative positive 8 Male + Tx X negative positive Male + None negative positive Male Neg Prophy X negative negative Male 4- TN X negative positive 9 Female + liininignininigniMinininiMininii,' negative negi'iih.*,,,,,,,,,, 1s4aW Neg None itegative negative Fiatlak 4, '.1.7X X negative positive Female + Tx X negative posit ive Mom Neg Prophy X negative negative Dad + Tx X negative posit il e + Tx X negative positive Fermi le -}- Tx X negative positive Neg PropIty X iingativa negative Female .-i.- Tx X Ilgigativc: posithv ...................................................
...............................................................................
...............................................................................
...............................................................................
...............................................................................
..........................
+ Tx. X negative positive 2 Son + negative positive Sib I Neg Prophy negative negative Sib 2 Neg Prophy negative negative Husband Neg Prophy negative negative :II 1 -i- Tx X ng.gotivo potttµv Pt2 -4.-. Tx: X Itegattve pl.>Otii,v Itoawniate Neg Prophy X Reptive: negative i.
Itoa&tniate 2 No,,, Prophy X negative negative Hongxotote Neg prophy X ............aleglitiVt:,::::::::: negative .3 -Hongxotote 4 NO, Propity :X .::::::ilaitivo negave HOittioTtift No, Propitir :X ng.gotivo ttegat)ive S
11 ..
.iiaiminote ii.,... Twipily X negative. nagaiive
6 :1-lonw,ratft Ni...,... Tsixipitv X
negative. nagaiive :1-lonwratft Nng Pratilty X ia,,galivc,:. negative Una s'entak:
Nng Pratilty X ia,,galivc,:. negative Una s'entak: Nol. prophv X IlgigaiiVC% tnaiiNT
.Hottriraate Nm. Prophy X: nagativa negative Morn + Tx negative positive Daughter Neg Prophy X negative negative Son Neg Prophy X negative negative Husband Neg Prophy X negative negative ...
Frat BOAUMNIMM: ..rX X. nagativa positiW
Frat Boy = 2::::::::::::::::::::::::::: Tx: :x negative po0;hre X nmitiw pl.>Otii,v ..........................
Mom. 110-4111:Prop hY negative negative Dad Meg Propily E,013AiNM agUivt!
IN negative post tiVe -}- Tx negative posit iN c Neg Prophy X negative negative Neg Prophy X negative negative 17 11ngba Tx: negative tny&ii Is X negative negative tsba ncl + Tx negative positive Wife Neg Prophy X negatiN e negative Shaer mptiw Gay Shaer Meg Propily X negative negative Meg Shelter Propily X negative negative Shelter rso 4 Neg Pawky X Reptiva negative Pen Sileltet Neg Pawky X Reptiva negative Person. *5 Neg Prophy Sktgltecomõ X negatheltr ive negative Neg Propht'''.1:Ii#0*0#1.4M
negative Shelter Nog prwity mgooiw Perkin.
Shelter Person 9 Nog Propity X nogativo negat)iw Shelter Prcipity X negative. negaiive Person 10 -:19 StiOltr g No Propity X negative. negaiive Perm 11 -1iitiOltr Net.r, Prnpk,, X negative native Perm 1,2. -Shelter Net.r, Prnpk,, X negative negative Pwestot '--Stioriter Nett Propity X mgaiive nega-tive Pwestot 14 Shaer Nett Propity mgative nega-tive Ilermn Shaer Neg Priv hy oegative negative Ilermn Shaer Neg Prop by .X oegative negative Shaer Meg Propily X negative negative POIVII
Shelter Person 19 'Meg Propily X negative negative Shelter Pero 20 Neg Pawky X Reptiva negative n Shelter g Praphy X negative negative Person 2.1 ShkAtr Ni....µg isKipily X negative negative Peron 22.
ShkAtr 2 Neg Prephy X negative negative Peron 2 Shelidi11111111111:::. ,., nt Ni Ptephy X negative negative -Prophy X nel.,.ar live u.egative Prwitgli:..
Stidt41iiiiiiiiiiiiiiiiiiiiii: .,., PrOpkv X ni,1,.ar livC: u.egative Person 26 ...............................................................................
.......... ...............................
...............................................................................
...............................................................................
.................................................................õ:õ........õ
Male 4. 20 Dentist Tx. negative positive Mom Neg Prophy X negative negative Ilx:gair% positive ..............................................Mk...............................
..............Na..................Prophy ::::::::::::::::::::::::::::::::::::,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:, :,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,:,::::::::::;;K::::::::::::::::::::::::
AWMaii::...............MPIIIN..........
Patient .1-Son Neg X negative positive Daughter Neg X negative negative Wife Neg X negative negative timuw:::::::::::::::::::::::::::::::::tx:
...ivegnive.......wrcegatown:
Pallier 2 negative posit iirgm Partier 3 4. Ts: X negative positive Pallier 4 + Tx X negative positive Pfiltiet .z.i.c: 4, Tx X Reptive: pAtive Partic/=: :+: Tx X negative positive Putian: 4, Tx X Reptive: pAtive Panic" g::: .-i- Tx. X ea the pesitiv:e Palter 9 .4- Tx X negative poitive Pali*" I.() -i- TX X IR,.ar 'OW pesitiv:e Palter 1.1. .4- Tx X ntgativ:0::: 110iw Pirrtiw '12 'Is: X ItqptiNM pOMA,Vg::
Nr0gs 1.1 + Tx X Bati Pirrtiw 14 .s::x iimitiv ptiM0a4 Pa rtigs 13 + Tx X BggatiNV pQit,iNV
23 Pallier 16 4. Ts: X negative positive Pallier 1.7 + Tx X negative positive Pallier IN 4. Ts: X negative positive Pallier 19 + Tx X negative positive Pfiltia 20 4, Tx X Reptive: pAtive Pattie/ 21 :+: Tx X negative positive Pfiltia 22 4, Tx X Reptive: pAtive Pattie/ 23 :+: Tx X negative positive Palter 24 .4- Tx X ntgatiw 110itiw Pali*" 25 .-i.- Tx X negatigg pesithe Palter 26 .4- Tx >i,,,-, Pali*" 27 .-i.- Tx X
nin.zar tivt pesitiv:e Pa rtigs 28 + Tx X BggatiNV pQit,iNV
Pirrtiw 29 f Tx: X
N30gs 30 + Tx X Bgati gNV õõ..:VMANCH
Nritiet 31. Meg Prophy X nAtv egie 1111410:43g0:V11111 Patient ix X negative negative 24 Mom Neg Prophy X negative positive Dad Neg Proplky X negative negative ...........................Brother Neg Prophy X negative.........negative.....
MONMEgP4%.10:irMgEgtUMNINMEAMMMEMEMEMEMEMEgMiii&tiMiVitraMilitidikeN
...............................................................................
...............................................................................
..................................................................
NgMMMgNaiNMMMMMMMgniMiiiMggggggggggggggggggggggggnUng!.W...I.tq'PMEIV..P..gM
Table 46 1002351 In all 25 households/events, all 80 individuals who were treated with the prevention protocols tested negative for COVID-19 via PCR at 3 months post exposure and tested negative for the presence of antibodies. Accordingly, none of the housemateslattendees in all 25 households/events ever became infected with COVID-19, despite living with at least one, and some cases multiple, infected individuals.
1002361 Having thus described the invention, it should be apparent that numerous structural modifications and adaptations may be resorted to without departing from the scope and fair meaning of the instant invention as set forth herein above and described herein below by the claims.
1002371 While particular forms of the invention have been illustrated and described, it will also be apparent to those skilled in the art that various modifications can be made without departing from the spirit and scope of the invention.
100238j Although the present invention has been described in considerable detail with reference to certain preferred embodiments, other embodiments are possible.
The forgoing description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. The steps disclosed for the present methods, for example, are not intended to be limiting nor are they intended to indicate that each step is necessarily essential to the method, but instead are exemplary steps only. Therefore, the scope of the appended claims should not be limited to the description of preferred embodiments/methods contained in this disclosure.
All references cited herein are incorporated by reference. Insofar as the description above and the accompanying drawings disclose any additional subject matter that is not within the scope of the claims below, the inventions are not dedicated to the public and the right to file one or more applications to claim such additional inventions is reserved.

Claims (20)

WHAT IS CLAIMED IS:
1. A method of preventing COVID-19 infection in an individual, the method comprising the steps of a) providing an individual that is not infected with COVID-19;
b) administering four antimicrobials to the individual, wherein the antimicrobials comprise:
i) administering chloroquine or hydroxychloroquine in a daily dosage range of 20 mg to 2,000 mg;
ii) administering vitamin C in a daily dosage range of 250 mg to 10,000 mg;
iii) administering vitamin D in a daily dosage range of 1,000 IU to 100,000 IU; and iv) administering zinc in a daily dosage range of 5 mg to 100 mg.
v) monitoring the individuals condition over a pre-determined amount of time to determine the individual does not becorne infected with COVID-19.
2. The method of claim1, wherein step b) comprises:
a) administering, on day 1:
i) 400 mg of hydroxychloroquine;
ii) 3,000 mg of vitamin C;
iii) 3,000 IU of vitamin D; and iv) 50 mg of zinc; and b) adrninistering on day 2:
i) 3,000 mg of vitarnin C;
ii) 3,000 IU of vitamin D; and iii) 50 mg of zinc.
3. The method of claim 1, wherein step b) further comprises before step v), administering ivermectin in a daily dosage range of 12 mg to 18 mg.
4. The method of claim 1, wherein step b) further comprises before step v), administering doxycycline in a daily dosage amount of 400 rng.
5. A method of preventing COVID-19 infection in an individual, the method comprising the steps of a) providing an individual that is not infected with COVID-19;
b) administering four antimicrobials to the individual, wherein the antimicrobials comprise:

hydroxychloroquine;
ii) vitamin C;
iii) vitamin D; and iv) zinc; and c) monitoring the individuals condition over a pre-determined amount of time to determine the individual does not become infected with COV1D-19.
6. The method of claim 6, wherein step b) comprises:
a) administering hydroxychloroquine in a daily dosage range of 20 mg to 2,000 mg;
b) administering vitamin C in a daily dosage range of 250 mg to 10,000 mg;
c) administering vitamin D in a daily dosage range of 1,000 IU to 100,000 1U;
and d) administering zinc in a daily dosage range of 5 mg to 100 mg.
7. The method of claim 6, wherein step b) further comprises administering ivermectin in a daily dosage range of 12 M2 to 18 mg.
8. The method of claim 6; wherein step b) further comprises administering doxycycline in a daily dosage amount of 400 mg.
9. The method of claim 6, wherein step b) comprises:
a) administering, on day 1:
i) 400 mg of hydroxychloroquine;
ii) 3,000 mg of vitamin C;
iii) 3,000 1U of vitamin D; and iv) 50 mg of zinc; and b) administering on day 2:
i) 3,000 mg of vitamin C;
ii) 3,000 1U of vitamin D; and iii) 50 mg of zinc.
10. A method of treating an individual infected with COVID-19, the method comprising the steps of a) providing an individual infected with COV1D-19;
b) administering five antimicrobials to the individual, wherein the antimicrobials comprise:
i) administering hydroxychloroquine in a daily dosage range of 200 mg to 1,000 mg;

ii) administering azithromycin in a daily dosage range of 250 mg to 500 mg;
iii) administering vitamin C in a daily dosage range of 1,000 mg to 10,000 mg;
iv) administering vitamin D in a daily dosage range of 3,000 1U to 40,000 1U; and v) administering zinc in a daily dosage range of 25 mg to 75 mg.
c) monitoring the individuals condition over a pre-determined period of time to determine whether the individual is no longer infected with COV1D-19.
11. The method of claim 10, wherein step b) further comprises vi) administering ivermectin in a daily dosage range of 12 mg to 18 mg.
12. The method of claim 10, wherein step b) further comprises administering doxycycline in a daily dosage amount of 400 mg.
13. The method of claim 11, wherein step b) comprises:
a) administering, on day 1:
i) 400 mg of hydroxychloroquine;
ii) 500 mg of azithromycin;
iii) 3,000 mg of vitamin C;
iv) 3,000 1U of vitamin D; and v) 50 mg of zinc;
b) administering daily, on days 2 to 5:
i) 400 mg of hydroxychloroquine;
ii) 250 mg of azithromycin;
iii) 3,000 mg of vitamin C;
iv) 3,000 1U of vitamin D; and v) 50 mg of zinc; and c) administering daily, on days 6 to 10:
i) 400 mg of hydroxychloroquine;
ii) 3,000 mg of vitamin C;
iii) 3,000 1U of vitamin D; and iv) 50 mg of zinc.
14. The method of claim 15, wherein step c) of administering on days 6 to 10 further comprises administering 250 mg of azithromycin.
15. A method of treating an individual infected with COV1D-19, the method comprising the steps of.
a) providing an individual infected with COV1D-19;
b) administering live antimicrobials to the individual, wherein the antirnicrobials comprise:
i) hydroxychloroquine;
ii) azithromycin;
iii) vitamin C;
iv) vitamin D; and v) zinc; and c) monitoring the individuals condition over a pre-determined period of time to determine whether the individual is no longer infected with COVID-19.
16. The method of claim 15, wherein step b) further comprises step administering ivermectin in a daily dosage range of 12 mg to 18 mg.
17. The method of claim. 15, wherein step b) further comprises administering doxycycline in a daily dosage amount of 400 mg.
18. The method of claim 15, wherein step b) comprises:
a) administering hydroxychloroquine in a daily dosage range of 200 mg to 1,000 mg;
b) administering azithromycin in a daily dosage range of 250 mg to 500 mg;
c) administering vitamin C in a daily dosage range of 1,000 mg to 10,000 mg;
d) administering vitamin D in a daily dosage range of 3,000 1U to 40,000 1U;
and e) administering zinc in a daily dosage range of 25 mg to 75 mg.
19. The method of claim 13, wherein step b) comprises:
a) administering, on day 1:
i) 400 mg of hydroxychloroquine;
ii) 500 mg of azithromycin;
iii) 3,000 mg of vitamin C;
iv) 3,000 1U of vitamin D; and v) 50 mg of zinc;
b) administering daily, on days 2 to 5:
i) 400 mg of hydroxychloroquine;
ii) 250 mg of azithromycin;
iii) 3,000 mg of vitamin C;

iv) 3,000 1U of vitamin D; and v) 50 mg of zinc; and e) administering daily, on days 6 to 10:
i) 400 mg of hydroxychloroquine;
ii) 3,000 rng of vitamin C;
iii) 3,000 1U of vitamin D; and iv) 50 rng of zinc.
20. The method of claim 19, wherein step c) of administering daily, on days 6 to 10, further comprises administering one dose of 250 mg of azithromycin.
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US202062993159P 2020-03-23 2020-03-23
US202062993370P 2020-03-23 2020-03-23
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US62/993,370 2020-03-23
US62/993,345 2020-03-23
US202063001161P 2020-03-27 2020-03-27
US63/001,161 2020-03-27
US202063002494P 2020-03-31 2020-03-31
US63/002,494 2020-03-31
US202063022371P 2020-05-08 2020-05-08
US202063022368P 2020-05-08 2020-05-08
US63/022,371 2020-05-08
US63/022,368 2020-05-08
US17/026,051 2020-09-18
US17/026,051 US11253534B2 (en) 2020-03-23 2020-09-18 Method of preventing COVID-19 infection
US202063110877P 2020-11-06 2020-11-06
US63/110,877 2020-11-06
US16/953,674 2020-11-20
US16/953,674 US20210290718A1 (en) 2020-03-23 2020-11-20 Methods of preventing and treating covid-19 infection
US17/114,271 US11278520B2 (en) 2020-03-31 2020-12-07 Method of preventing COVID-19 infection
US17/114,271 2020-12-07
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