Prothione LLC, a U.S. based pharmaceutical company announced results from a Phase II trial of Prothione capsules for the treatment of mild to moderate COVID-19. The data show that patients assigned treatment with the drug had a reduction in time to clinical resolution as defined by the time to attain 3 consecutive negative RT-PCR tests and a statistically significant decrease in viral load of COVID-19. Prothione was also found to be safe and well tolerated.
Prothione is a pro-glutathione therapy that provides the precursors to help the body produce intracellular glutathione (GSH). The capsules contain three amino acids known to increase intracellular glutathione, reduce oxidative stress, and inhibit inflammatory reactions in patients with COVID-19
In the trial titled “A Phase 2, Proof of Concept, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ProthioneTM Capsules for Mild to Moderate COVID-19,” Prothione capsules showed a mean change in viral load of COVID-19 from baseline to day 14 of 43,337 c/mL vs 7,039.7 c/mL for placebo (P = .0347). Additionally, there was a marked increase in red blood cell GSH levels from baseline to day 29 in Prothione of 156.9 (N95) vs 107.3 (N83) for placebo.
Ongoing analysis also shows that moderately infected COVID-19 patients appear to have a greater response to Prothione capsules due to lower GSH levels at time of entry into the trial. During this pivotal trial, there was a significant reduction in hospitalizations among Prothione-treated patients, with only one hospitalization compared with four COVID-19 related hospitalizations in patients in the placebo group. This suggests that the drop in viral load helped reduce progression and severity of disease.