Tafenoquine may decrease the time to clinical recovery for patients with mild to moderate COVID-19 infecton, according to results of a study published in New Microbes and New Infections.
This randomized, double-blind, placebo-controlled trial was conducted at 15 sites in the United States between March and September 2021. Patients (N=86) with mild to moderate COVID-19 infection were randomly assigned in a 1:1 fashion to receive either two 100-mg tablets of tafenoquine (n=45) or placebo (n=41), administered on days 1, 2, 3, and 10. Patients self-reported symptom severity and adverse events (AEs) throughout the 28-day follow-up period. The primary endpoint was clinical recovery by day 14, defined as mild or absent cough, a respiratory rate of more than 24/min, and the absence of dyspnea or fever.
Among patients in the tafenoquine (n=45) and placebo (n=41) groups, the mean age was 43 years, 53% and 51% were women, 96% and 100% were White, and 31% and 34% were vaccinated against COVID-19 infection, respectively.
At day 14, clinical recovery was observed among 17.8% of patients who received tafenoquine compared with 24.4% of those who received placebo. By day 24, 15.5% and 22% of patients in the tafenoquine and placebo groups had not experienced clinical recovery, respectively.
Further analysis performed at day 14 showed that self-reports of nonallergic rhinitis (88% vs 76%), dyspnea (84% vs 78%), cough (76% vs 61%), and fatigue (69% vs 51%) were more frequent among patients who received tafenoquine vs those who received placebo. Patients who received placebo, however, more frequently reported pharyngitis (90% vs 87%), body aches (81% vs 76%), headache (95% vs 93%), and fever (95% vs 91%).
The mean time to clinical recovery was 2.1 days in patients who received tafenoquine compared with 6.5 days among those who received placebo (P =.053).
The researchers noted that 1 patient in the tafenoquine group and 2 in the placebo group were hospitalized with COVID-19 pneumonia and subsequently lost to follow-up. In addition, mild adverse events related to treatment were reported by 4 patients who received tafenoquine and 1 who received placebo.
This study was limited by its small sample size and early termination.
“Assuming clinical benefit is confirmed in a larger study, tafenoquine has potential advantages and disadvantages over other oral COVID-19 therapeutics,” the researchers concluded.
Disclosure: Multiple authors declared affiliations with industry. Please see the original reference for a full list of disclosures.
Dow GS, Smith BL. A phase II, double blind, placebo-controlled, randomized evaluation of the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 disease. New Microbes New Infect. 2022;100986. doi:10.1016/j.nmni.2022.100986