Compositions and methods for treatment of SARS-COV-2
Disclosed herein are formulations comprising recombinant human angiotensin converting enzyme 2 (rhACE-2) and a cellulose derivative for the prevention and treatment of a coronavirus infection. Methods and kits are also provided herein.
1. A method of treating a subject infected with or at risk of being infected with a coronavirus, the method comprising administering to the subject a therapeutically effective amount of a formulation comprising:
(a) a recombinant angiotensin converting enzyme 2 (rACE-2) protein that specifically binds to a coronavirus protein, wherein the rACE-2 protein comprises an amino acid sequence with at least 90% sequence identity to SEQ ID NO:2;
(b) a cellulose derivative selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), or a combination thereof; and
(c) an excipient selected from a glycol alcohol, a sugar alcohol, an acid, an ester, or any combination thereof, wherein the rACE-2 protein is at a concentration of about 2 percent weight/weight (w/w).
2. The method of claim 1 , wherein the administering is intranasally, orally, or topically.
3. The method of claim 1 , wherein the rACE-2 protein comprises the amino acid sequence of SEQ ID NO:2.
4. The method of claim 1 , wherein the rACE-2 protein consists of the amino acid sequence of SEQ ID NO: 2.
5. The method of claim 1 , wherein the coronavirus is an alphacoronavirus or a betacoronavirus.
6. The method of claim 5 , wherein the betacoronavirus is HCoV-NL63, SARS-CoV-1, or SARS-CoV-2.
7. The method of claim 1 , wherein the coronavirus is a SARS-CoV-2 coronavirus.
8. The method of claim 1 , wherein the subject is a human subject.
9. A method of treating a subject infected with or at risk of being infected with a coronavirus, the method comprising administering to the subject a therapeutically effective amount of a formulation comprising:
(a) a recombinant angiotensin converting enzyme 2 (rACE-2) protein that specifically binds to a coronavirus protein, wherein the rACE-2 protein comprises an amino acid sequence with at least 90% sequence identity to SEQ ID NO:2;
(b) a cellulose derivative selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), or a combination thereof; and
(c) a glycol alcohol at a concentration of about 1 percent w/w to about 10 percent w/w, wherein the glycol alcohol is an excipient.
10. A method of treating a subject infected with or at risk of being infected with a coronavirus, the method comprising administering to the subject a therapeutically effective amount of a formulation comprising:
(a) a recombinant angiotensin converting enzyme 2 (rACE-2) protein that specifically binds to a coronavirus protein, wherein the rACE-2 protein comprises an amino acid sequence with at least 90% sequence identity to SEQ ID NO:2;
(b) a cellulose derivative selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), or a combination thereof; and
(c) mannitol, wherein the mannitol is an excipient.
11. The method of claim 10 , wherein the mannitol is at a concentration of about 0.01 percent w/w to about 10 percent w/w.
12. A method of treating a subject infected with or at risk of being infected with a coronavirus, the method comprising administering to the subject a therapeutically effective amount of a formulation comprising:
(a) a recombinant angiotensin converting enzyme 2 (rACE-2) protein that specifically binds to a coronavirus protein, wherein the rACE-2 protein comprises an amino acid sequence with at least 90% sequence identity to SEQ ID NO:2;
(b) a cellulose derivative selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), or a combination thereof; and
(c) sorbic acid, wherein the sorbic acid is an excipient.
13. The method of claim 12 , wherein the sorbic acid is at a concentration of about 0.01 percent w/w to about 1 percent w/w.
14. A method of treating a subject infected with or at risk of being infected with a coronavirus, the method comprising administering to the subject a therapeutically effective amount of a formulation comprising:
(a) a recombinant angiotensin converting enzyme 2 (rACE-2) protein that specifically binds to a coronavirus protein, wherein the rACE-2 protein comprises an amino acid sequence with at least 90% sequence identity to SEQ ID NO:2;
(b) a cellulose derivative selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), or a combination thereof; and
(c) polysorbate 20, wherein the polysorbate 20 is an excipient.