Treatment for coronavirus infection and associated cytokine toxicity
View Patent ↗The present invention relates to novel methods comprising the administration of pentosan polysulfate for treating or preventing coronavirus infection and cytokine-associated toxicity, including cytokine toxicity resulting from aberrant activation of the immune system in coronavirus disease or infection, such as those from SARS-CoV-2.
1. A method of treating or preventing coronavirus infection or a disease or condition caused by or associated with coronavirus infection, the method comprising
administering to an individual suspected of having, or of having had a coronavirus infection, a therapeutically effective amount of pentosan polysufate (PPS) or a pharmaceutically acceptable salt thereof;
thereby treating or preventing coronavirus infection or a disease or condition caused by or associated with coronavirus infection in the individual.
2. The method of claim 1 , wherein the disease or condition caused by or associated with coronavirus infection is a respiratory disease or condition, an inflammatory disease or condition, a cardiovascular disease or condition or a gastrointestinal disease or condition.
3. The method of claim 1 , wherein the disease or condition caused by or associated with coronavirus infection is cytokine-associated toxicity.
4. The method of claim 1 , wherein the disease or condition is characterised as a mild condition.
5. The method of claim 1 , wherein the disease or condition is characterised as severe.
6. The method of claim 1 , wherein the individual does not display symptoms of coronavirus infection.
7. A method of preventing cytokine-associated toxicity induced by coronavirus infection, the method comprising administering to an individual who had been exposed to, or has, or is recovering from a coronavirus infection a therapeutically effective amount of PPS or a pharmaceutically acceptable salt thereof;
thereby preventing cytokine-associated toxicity in the individual.
8. The method according to claim 7 , wherein the cytokine-associated toxicity is characterized by one or more of fever, hypotension, tachycardia, myalgia, headache and elevated levels of one or more cytokines selected from the group consisting of: IL-1B, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-13, IL-17 INFγ, TNF-α, and granulocyte macrophage colony-stimulating factor.
9. The method of claim 1 , wherein the method comprises treating one or more of fever, hypotension, tachycardia, myalgia, headache or inappropriate cytokine release induced by coronavirus infection.
10. The method of claim 1 , wherein the PPS is administered prior to or after the onset of coronavirus infection.
11. The method of claim 1 , wherein the PPS is administered prophylactically once the individual has recovered from an initial infection with coronavirus.
12. A method of preventing or reducing the likelihood of coronavirus infection in an individual, the method comprising administering to an individual who is at risk of infection with a coronavirus, a prophylactically effective amount of PPS, or a pharmaceutically acceptable salt thereof;
thereby preventing or reducing the likelihood of coronavirus infection in an individual.
13. The method of claim 12 , wherein the method reduces the likelihood of serious coronavirus infection.
14. The method of claim 12 , wherein the individual at risk is an immunocompromised individual.
15. The method of claim 1 , wherein the PPS is administered to the individual intravenously, subcutaneously, orally, intramuscularly, via gastric tube, intranasally or by inhalation.
16. The method of claim 1 , wherein the PPS is provided as a salt.
17. The method of claim 1 , wherein the coronavirus infection is an infection with SARS-COV-2 or variant or mutated form thereof.
18. The method of claim 1 , wherein the method includes further administering to the individual one or more of: a corticosteroid, an IL-6 inhibitor, a TNF-α inhibitor or a vasopressor.
19. The method of claim 3 , wherein the cytokine-associated toxicity is hypercytokinemia.
20. The method of claim 14 , wherein the immunocompromised individual is an individual who has primary or secondary immunodeficiency.
21. The method of claim 1 , wherein the disease or condition caused by or associated with coronavirus infection is long COVID.
22. The method of claim 1 , wherein the individual is selected from:
immunocompromised individuals (including an individual who has primary or secondary immunodeficiency), an adult more than 60 years of age, a child younger than 2 years of age, healthcare workers, adults or children in close contact with a person(s) with confirmed or suspected coronavirus infection, and people with underlying medical conditions such as pulmonary infection, heart disease, obesity or diabetes.
23. The method according to claim 3 , wherein the cytokine-associated toxicity is characterized by one or more of fever, hypotension, tachycardia, myalgia, headache and elevated levels of one or more cytokines selected from the group consisting of: IL-1B, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-13, IL-17 INFγ, TNF-α, and granulocyte macrophage colony-stimulating factor.
24. The method of claim 7 , wherein the PPS is administered prior to or after the onset of coronavirus infection.
25. The method of claim 7 , wherein the individual is selected from:
immunocompromised individuals (including an individual who has primary or secondary immunodeficiency), an adult more than 60 years of age, a child younger than 2 years of age, healthcare workers, adults or children in close contact with a person(s) with confirmed or suspected coronavirus infection, and people with underlying medical conditions such as pulmonary infection, heart disease, obesity or diabetes.
26. The method of claim 7 , wherein the PPS is provided as a salt.
27. The method of claim 7 , wherein the coronavirus infection is an infection with SARS-CoV-2 or variant or mutated form thereof.
28. The method of claim 7 , wherein the cytokine-associated toxicity is hypercytokinemia.
29. The method of claim 7 , wherein the method further prevents long COVID.
30. The method of claim 12 , wherein the individual does not display symptoms of coronavirus infection.
31. The method of claim 12 , wherein the PPS is administered to the individual intravenously, subcutaneously, orally, intramuscularly, via gastric tube, intranasally or by inhalation.
32. The method of claim 12 , wherein the PPS is provided as a salt.
33. The method of claim 12 , wherein the coronavirus infection is an infection with SARS-COV-2 or variant or mutated form thereof.
34. The method of claim 12 , wherein the PPS is administered prophylactically once the individual has recovered from an initial infection with coronavirus.