Abstract
The safety and efficacy of tafenoquine administered as a 200 mg dose once per day on days 1, 2, 3, and 10 was evaluated over a 28-day period in mild-moderate COVID-19 patients. The primary endpoint was Day 14 clinical recovery from COVID-19 symptoms, defined as cough mild or absent, respiratory rate < 24 bpm, and no shortness of breath or fever. Following a successful futility analysis after n = 86 patients out of a target n = 275 were randomized, the study was terminated and unblinded early to facilitate planning for confirmatory studies. The proportion of patients not recovered on Day 14 was numerically decreased by 27% in the ITT population [8/45 v 10/42 not recovered in the tafenoquine and placebo arms, P = 0.60] and 47% in the PP population [5/42 v 9/41, P = 0.25]. Amongst individuals who recorded responses in an electronic diary at Day 28, all tafenoquine patients were recovered, whereas up to 12% of placebo patients exhibited lingering dyspnea. Time to clinical recovery from COVID-19 symptoms was accelerated in the tafenoquine arm by about 2-2.5 days. There were two COVID-19 related hospitalizations in the placebo arm and one in the tafenoquine arm. Mild, drug related adverse events occurred in 8.4% of individuals in the tafenoquine arm [v 2.4% in the placebo]. Although this trial was underpowered for the primary endpoint due to its early termination, the data are suggestive of a therapeutic benefit associated with tafenoquine administration in outpatients with mild to moderate COVID-19 disease, and larger studies are planned.
【저자키워드】 COVID-19, clinical trial, outpatients, tafenoquine, FDA-Approved Regimen for Malaria Pophylaxis, 【초록키워드】 Efficacy, Trial, Hospitalization, cough, Moderate COVID-19, clinical recovery, Randomized, response, Fever, Dyspnea, adverse event, Patient, Mild, Placebo, disease, COVID-19 symptoms, COVID-19 patients, Outpatient, administration, primary endpoint, Analysis, dose, respiratory rate, COVID-19 symptom, Shortness of breath, ARMS, Therapeutic benefit, PP population, individual, Administered, time, ITT population, defined, occurred, proportion, evaluated, Day, facilitate, exhibited, per day, accelerated, recorded, bpm, the primary endpoint, 【제목키워드】 Efficacy, COVID-19 disease, Randomized, Patient, double blind, placebo-controlled,