# US 2021/0330635 A1 · Therapeutic compositions, products of manufacture and methods for ameliorating or preventing coronavirus infection

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2021/0330635 A1
- Document ID: US20210330635A1
- Status: Published application
- Kind: A1
- Application number: 17/371,036
- Filed: 2021-07-08
- Published: 2021-10-28
- Earliest claimed: 2020-02-07
- Assignees: Centre for Digestive Diseases
- Applicants: Centre for Digestive Diseases
- Inventors: Thomas Julius BORODY
- Web page: https://patentgrep.com/patent/US20210330635A1

## CPC

- A61K 31/35: having six-membered rings with one oxygen as the only ring hetero atom
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/215: of carboxylic acids
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/426: 1,3-Thiazoles
- A61K 31/427: not condensed and containing further heterocyclic rings
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 31/4409: only substituted in position 4, e.g. isoniazid, iproniazid
- A61K 31/47: Quinolines; Isoquinolines
- A61K 31/4706: 4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/65: Tetracyclines
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 31/7052: having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K 31/706: containing six-membered rings with nitrogen as a ring hetero atom
- A61K 33/30: Zinc; Compounds thereof
- A61K 38/21: Interferons {[IFN]}
- A61K 39/215: Coronaviridae, e.g. avian infectious bronchitis virus
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61M 15/0045: {using multiple prepacked dosages on a same carrier, e.g. blisters}
- A61M 15/0068: {Indicating or counting the number of dispensed doses or of remaining doses}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 15/08: Inhaling devices inserted into the nose
- A61P 31/14: for RNA viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61M 2202/064: Powder
- C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

In alternative embodiments, provided are pharmaceutical compositions comprising combinations of drugs, including products of manufacture and kits, and methods for using them, for treating, preventing, ameliorating, slowing the progress of, decreasing the severity of or preventing a coronavirus infection, or a COVID-19 or a 2019-nCoV (or so-called Wuhan coronavirus) infection, or an infection caused by a virus in the subfamily Orthocoronavirinae, or a virus in the family Coronaviridae, or a virus in the order Nidovirales. In alternative embodiments, combinations, or cocktails, of a drug or drugs as provided herein are administered either enterally, parenterally and/or by inhalation. In alternative embodiments, combinations, or cocktails, of drugs as provided herein are used to block intracellular metabolic pathways and prevent progression of the infection to clinical illness and death. In alternative embodiments, novel aerosol, spray or mist or powder formulations for inhalation are provided. In alternative embodiments, provided are therapeutic combinations of drugs or a drug, a pharmaceutical dosage form, a drug delivery device, or a product of manufacture, comprising: opaganib or YELIVA™, or opaganib or YELIVA™ and oral and/or inhaled chloroquine (or ARALEN™) chloroquine phosphate, chloroquine diphosphate and/or hydroxychloroquine (optionally, PLAQUENIL™), with or without azithromycin, wherein optionally each or all of the opaganib, the chloroquine (or ARALEN™), chloroquine phosphate, chloroquine diphosphate and/or hydroxychloroquine (optionally, PLAQUENIL™) and/or azithromycin, and others, are in or formulated as a formulation for inhalation, for example, formulated as an aerosol, spray, mist, liquid or powder.

## Claims

### Claim 1

A method for treating, preventing, ameliorating, slowing the progress of, decreasing the severity of or preventing a coronavirus infection, or a COVID-19 infection, or an infection caused by a virus in the sub-family Orthocoronavirinae, or a virus in the family Coronaviridae, or a virus in the order Nidovirales, comprising administering to an individual in need thereof a therapeutic combination of drugs, a pharmaceutical dosage form, a drug delivery device, or a product of manufacture comprising: ivermectin; an antibiotic, and zinc.

### Claim 2 (depends on 1)

The method of claim 1, wherein the antibiotic in the therapeutic combination of drugs comprises a tetracycline class drug.

### Claim 3 (depends on 2)

The method of claim 2, wherein the tetracycline class drug comprises doxycycline.

### Claim 4 (depends on 3)

The method of claim 3, wherein the therapeutic combination of drugs comprises between about 25 mg to about 600 mg doxycycline.

### Claim 5 (depends on 1)

The method of claim 1, wherein the antibiotic in the therapeutic combination of drugs comprises azithromycin.

### Claim 6 (depends on 5)

The method of claim 5, wherein the therapeutic combination of drugs comprises between about 50 mg to about 2000 mg azithromycin.

### Claim 7 (depends on 5)

The method of claim 5, wherein the azithromycin comprise an oral extended-release formulation of azithromycin.

### Claim 8 (depends on 1)

The method of claim 1, wherein the zinc comprises a zinc sulphate, a zinc acetate, a zinc gluconate or a zinc picolinate.

### Claim 9 (depends on 1)

The method of claim 1, comprising between about 1 mg to about 250 mg zinc.

### Claim 10 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs further comprises a vitamin.

### Claim 11 (depends on 10)

The method of claim 10, wherein the vitamin comprises vitamin D or cholecalciferol.

### Claim 12 (depends on 11)

The method of claim 11, wherein the therapeutic combination of drugs comprises between about 3,000 to about 100,000 units vitamin D or cholecalciferol.

### Claim 13 (depends on 12)

The method of claim 12, comprising between about 10,000 to about 50,000 units vitamin D or cholecalciferol.

### Claim 14 (depends on 10)

The method of claim 10, wherein the vitamin comprises vitamin C.

### Claim 15 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs is formulated as a liquid or an aerosol.

### Claim 16 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs is formulated as a powder.

### Claim 17 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs is formulated as a tablet, capsule, tablet or geltab.

### Claim 18 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs is formulated as an injectable formulation, or an intramuscular (IM) or intravenous (IV) formulation.

### Claim 19 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs further comprises hydrocortisone, cortisol or dexamethasome.

### Claim 20 (depends on 1)

The method of claim 1, wherein the therapeutic combination of drugs further comprises hydroxychloroquine.