IP Library Granted Patent US 12,233,122
Granted Patent B2
US 12,233,122 · App. 18/649,981 · Granted Feb 25, 2025

Methods for treating, ameliorating or preventing infections using drug and vaccination combination treatment

Inventor: Thomas Julius Borody (Five Dock, AU)
Assignee: TOPELIA AUST LIMITED (652 771 670)
A61K39/12A61K31/166A61K45/06A61P31/14C12N7/00A61K2039/545
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Quick Facts
Patent No.
US 12,233,122
App. No.
18/649,981
Granted
Feb 25, 2025
Kind
B2
Abstract

In alternative embodiments, provided are methods for treating, ameliorating, decreasing the chances of having any adverse effects from, decreasing the severity of adverse effects from a coronavirus infection, comprising administering to a subject or an individual in need thereof: (a) an anti-viral drug combination capable of killing a causative agent of the infection, or completely or partially inhibiting the ability of the causative agent of the infection to replicate or become infectious or cause pathology in the subject or the individual in need thereof, wherein the anti-viral drug combination comprises: (i) 1R,2S,5S)—N-[(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide, and (ii) ritonavir; and, (b) an inactivated or attenuated agent of the infection, or a live, viable or infectious causative agent of the infection, or a live causative agent of the infection that is a completely or partially attenuated version of the causative agent, wherein at least one dosage of the anti-viral drug combination is administered to the subject or the individual in need thereof 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 or more days before, or on the day of, and/or is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 or more days after, a first dose of the inactivated or attenuated agent of the infection.

Claims (27)

1. A method for treating, ameliorating, decreasing the chances of having any adverse effects from, decreasing the severity of adverse effects from a coronavirus infection, comprising administering to a subject or an individual in need thereof:

(a) a drug combination comprising

ritonavir, hydroxychloroquine and azithromycin; and,

(b) an inactivated or attenuated agent of the coronavirus infection

wherein at least one dosage of the anti-viral drug combination is administered to the subject or the individual in need thereof 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 or more days before, or on the day of, and/or is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 or more days after, a first dose of the inactivated or attenuated agent of the infection, and

zinc or a zinc salt and/or an oral extended-release formulation of azithromycin.

2. The method of claim 1 , wherein the inactivated or attenuated agent of the infection is formulated for administration as an aerated dose or by inhalation.

3. The method of claim 1 , wherein a booster, or at least one second or first follow-up administration of: the inactivated or attenuated agent of the infection is given between about 1 week to one year after the first administration of the inactivated or attenuated agent of the infection.

4. The method of claim 1 , wherein a second booster, or at least one second follow-up administration of the inactivated or attenuated agent of the infection is administered at least one day, or about two days, or between about 1 week to one year after administration of the second booster or after administration of at least one second follow-up administration.

5. The method of claim 1 , wherein the inactivated or attenuated agent of the infection, or the anti-viral drug combination, is formulated in or on a nanoparticle, a liquid (optionally to be administered as a drink or in drops such as nasal drops or in a mist or as a powder), a tablet, a capsule, a gel, a geltab, a powder, a lozenge, an aerosol, spray, or mist formulation that is inhaled or administered nasally or orally, or the attenuated or inactivated infectious causative agent of the infection is formulated in a liquid solution which is ingested or gargled by the individual in need thereof.

6. The method of claim 1 , wherein the inactivated or attenuated agent of the infection is administered in unit dosages of between about 10 to 50 trillion infectious units or particles, or between about one infectious unit or particle to 10, 20 or 30 billion infection units or particles.

7. The method of claim 1 , wherein the individual in need thereof is a human or an animal.

8. The method of claim 1 , wherein the anti-viral drug combination is formulated to be administered orally, intramuscularly, subcutaneously, topically, by use of an enema, intravaginally, or intravenously, or formulated for subcutaneous administration, sublingual administration, inhalation or by aerosol, by absorbable patch, by use of an implant, or by use of an enema or a suppository.

9. The method of claim 1 , wherein the ritonavir

is administered a dosage of QD (once a day), bid (twice a day) or tid (three times a day) at a dosage of between about 100 to 600 mg per day or per dosage, or at about 100, 200, 300, 400, 500 or 600 mg per day or per dosage, or

at a dosage of between about 10 mg to 3 gm per dose, or between about 10 mg to 3 gm per day, or

is dosed either as a single dose or given one, two, three or four times a day, or

is dosage at 200 to 800 mg twice daily, or 200, 400, 600 or 800 mg twice daily, or at 200 to 800 mg three times a day, or at 200, 400, 600 or 800 mg three times a day, or is administered at 200 to 800 mg three times a day for between about 2 to 15 days, or for about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 days.

10. The method of claim 1 , wherein a booster, or at least one second or first follow-up administration of: the inactivated or attenuated agent of the infection is given between about two weeks to 9 months, or between about three weeks to 8 months, or between about one month to 7 months, or about 3, 4, 5, or 6 months after the first administration of the inactivated or attenuated agent of the infection.

11. The method of claim 1 , wherein a second booster, or at least one second follow-up administration of the inactivated or attenuated agent of the infection is administered between about two weeks to 9 months, or about 3, 4, 5, or 6 months after administration of the second booster or after administration of at least one second follow-up administration.

12. The method of claim 11 , wherein a second booster, or at least one second follow-up administration of the inactivated or attenuated agent of the infection is administered between about three weeks to 8 months, or between about one month to 7 months, after administration of the second booster or after administration of at least one second follow-up administration.

13. The method of claim 5 , wherein the nanoparticle comprises a nanosphere or nanocapsule.

14. The method of claim 5 , wherein the liquid is administered as a drink or in drops such as nasal drops or in a mist or as a powder.

15. The method of claim 5 , wherein the inactivated or attenuated agent of the infection, or the anti-viral drug combination, is inhaled or administered nasally or orally by a nasal inhaler, a puffer or a nebulizer.

16. The method of claim 6 , wherein the inactivated or attenuated agent of the infection is administered in unit dosages of between about 10 to 50 trillion infectious units of chemically inactivated virus.

17. The method of claim 15 , wherein the chemically inactivated virus comprises iodine-inactivated virus.

18. The method of claim 1 , wherein the coronavirus infection is a COVID-19 infection.

Continuity (9)
Continuation 17525775 · Nov 12, 2021
Provisional Application 63273069 · Oct 28, 2021
Provisional Application 63253813 · Oct 8, 2021
Provisional Application 63241485 · Sep 7, 2021
Provisional Application 63223427 · Jul 19, 2021
Provisional Application 63214997 · Jun 25, 2021
Provisional Application 63188311 · May 13, 2021
Provisional Application 63186660 · May 10, 2021
Related Publication 20240382578A1 · Nov 21, 2024
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