Amino acid compositions and methods for the treatment of post-acute sequelae of COVID-19
This disclosure provides pharmaceutical compositions comprising amino acid entities and uses thereof. Methods for treating post-acute sequelae of COVID-19 comprising administering an effective amount of the compositions to a subject in need thereof are also disclosed.
1. A method of treating a subject having post-acute sequelae of COVID-19 (PASC), wherein the subject has one or more symptoms or signs selected from the group consisting of fatigue, myalgia, fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), idiopathic pulmonary fibrosis, confusion, muscle dysfunction, mitochondrial dysfunction, dyspnea after exertion, postural orthostatic tachycardia syndrome, tachycardia, mood disorders, and depression, comprising administering to the subject:
a) a leucine (L)-amino acid or salt thereof;
b) an arginine (R)-amino acid or salt thereof;
c) a glutamine (Q)-amino acid or salt thereof; and
d) N-acetylcysteine (NAC) or a salt thereof.
2. The method of claim 1 , wherein the subject experiences fatigue.
3. The method of claim 2 , wherein the fatigue comprises one or both of persistent fatigue and exertional fatigue.
4. The method of claim 2 , wherein the fatigue comprises one or both of mental fatigue and physical fatigue.
5. The method of claim 2 , wherein the subject experiences fatigue at at least 4 weeks after infection with SARS-Cov-2.
6. The method of claim 1 , wherein prior to administration of (a)-(d) the subject has a score of greater than or equal to 8 on a CFQ-11 test using bimodal scoring.
7. The method of claim 1 , wherein after administration of (a)-(d) the subject has a decrease of at least 1 point on a CFQ-11 test using bimodal scoring, relative to the subject's score before administration.
8. The method of claim 1 , wherein administration of (a)-(d) results in an increase in MOTS-c levels in the subject.
9. The method of claim 1 , wherein administration of (a)-(d) results in a decrease in bicarbonate levels or sVCAM-1 levels in the subject.
10. The method of claim 1 , wherein (a)-(d) are administered separately to the subject.
11. The method of claim 1 , which comprises administering a composition comprising (a)-(d) to the subject.
12. The method of claim 1 , wherein (a)-(d) are administered to the subject twice per day (BID) for at least 4 weeks.
13. The method of claim 1 , wherein at least 50 wt. % of the total wt. of components administered to the subject is one or more amino acid entities in free form.
14. The method of claim 11 , wherein the total wt. % of (a)-(d) is greater than the total wt. % of other amino acid entities in the composition.
15. The method of claim 1 , wherein at least one of (a)-(d) is in a salt form.
16. The method of claim 1 , wherein one, two, three, or more of methionine (M), tryptophan (W), or cysteine (C) is absent, or if present, is present at less than 10 weight (wt.) %.
17. The method of claim 1 , wherein a wt. ratio of the L-amino acid or salt thereof, the R-amino acid or salt thereof, the Q-amino acid or salt thereof, and the NAC or salt thereof administered to the subject is 0.5 to 3:0.5 to 4:1 to 4:0.1 to 2.5.
18. The method of claim 1 , further comprising administering one or both of:
(e) an isoleucine (I)-amino acid or salt thereof; and
(f) a valine (V)-amino acid or salt thereof.
19. The method of claim 18 , wherein the wt. ratio of the L-amino acid or salt thereof, the I-amino acid or salt thereof, the V-amino acid or salt thereof, the R-amino acid or salt thereof, the Q-amino acid or salt thereof, and the NAC or salt thereof administered is 0.5 to 2:0.1 to 1:0.1 to 1:0.5 to 3:0.5 to 4:0.1 to 0.5.
20. The method of claim 11 , wherein 25-40 g of the composition is administered to the subject BID, wherein weight includes amino acids or salts thereof and NAC but does not include excipients.
21. The method of claim 1 , wherein the subject has been hospitalized for acute COVID-19.
22. The method of claim 1 , wherein the subject had not been vaccinated for COVID-19 prior to contracting COVID-19.
23. The method of claim 1 , wherein the subject had been vaccinated for COVID-19 prior to contracting COVID-19.
24. The method of claim 1 , wherein the subject tested positive for SARS-COV-2 and developed symptoms consistent with infection.
25. The method of claim 1 , wherein the subject tested positive for SARS-COV-2 and was asymptomatic, but later developed symptoms consistent with PASC.