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Ivermectin, Fluticasone, Fluvoxamine Can't Beat Placebo for Mild/Moderate COVID
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IDWeek 2022, October 19-23, 2022, Washington, DC
Mark Mascolini
Three drugs licensed for non-COVID conditions-ivermectin, inhaled fluticasone, and low-dose fluvoxamine-did no better than placebo in relieving mild to moderate COVID symptoms in the ongoing US ACTIV-6 trial [1-4]. Nor did any of the three drugs cut the number of hospital admissions or emergency room visits in this trial enrolling 4156 people with COVID symptoms.
ACTIV-6 is a direct-to-participant trial whose enrollees never make an in-person study visit. They report symptoms daily in an online session, and trial staff urges them to seek in-person care if their condition worsens. Aiming to study drugs already licensed for non-COVID conditions, ACTIV-6 has had five active arms so far; this presentation detailed findings in placebo-controlled comparisons of the antiparasitic ivermectin, the steroid fluticasone, and the selective serotonin reuptake inhibitor (SSRI) fluvoxamine.
When a person enters the trial, they may opt out of randomization to any active-drug arm but they may not opt out of randomization to placebo. If a person entered ACTIV-6 when ivermectin, fluticasone, and fluvoxamine were in active-drug arms and that person agreed to participate in the study of any of the three drugs, their chance of being assigned an active drug would be 75%. Neither participants nor researchers knew whether a person got randomized to an active drug or placebo.
Participants had to be 30 or older, have a positive COVID test within 10 days, and have at least two COVID symptoms for up to 7 days. After randomization, they reported symptoms and other information daily in an online survey every day for 14 days then completed follow-up surveys on days 21, 28, and 90. Active interventions covered in this analysis were (1) ivermectin dosed to attain 400 ug/kg daily for 3 days, (2) fluticasone furoate at a dose of 200 ug/day inhaled daily for 14 days, and (3) fluvoxamine maleate given as a 50-mg tablet twice daily for 10 days.
In the active and placebo arms, there were 817 and 774 people in the ivermectin study, 656 and 621 in the fluticasone study, and 674 and 614 in the fluvoxamine study. Across those six groups, median age ranged from 45 to 48, proportions under 50 years old from 56.2% to 61.7%, proportions of women from 54.8% to 62.2%, and proportions of blacks from 7.0% to 8.0%, whites from 79.7% to 81.0%, and Hispanics from 9.0% to 17.7%. Across these treatment groups, median body mass index lay at about 28 kg/m2 (overweight), about 4% had a history of heart disease, about 10% had diabetes, about 13% had asthma, and about 13% smoked. About 47% in the ivermectin study had 2 or more COVID vaccine doses, and about two thirds in the fluticasone and fluvoxamine studies had 2 or more vaccine doses. In none of these measures did the active drug arms differ much from the placebo arms.
Across the six study arms-that is, the active and placebo arms of the ivermectin, fluticasone, and fluvoxamine studies-the researchers recorded little difference in proportion with any adverse event (ranging from 1.98% to 5.05%) or proportion with a serious adverse event (ranging from 0.46% to 1.2%). Adverse event rates did not differ significantly between active-drug arms and placebo arms in any of the three studies.
Among people who did not die during follow-up, recovery defined as 3 consecutive participant-reported days without COVID symptoms differed little between active-drug arms and placebo arms of any of the three studies. Through 28 days of follow-up in each of the three studies, active-drug groups did not differ much from comparison placebo groups in (1) mortality, (2) death or hospitalization, (3) hospitalization, urgent or emergency care visit, or death or (4) WHO Clinical Progression Scale. There was a single difference between an active drug and placebo in these comparisons: People taking fluticasone versus placebo had about a twice higher rate of hospitalization, urgent or emergency care, or death (hazard ratio 1.9, P = 0.035).
ACTIV-6 investigators concluded that ivermectin, or fluticasone, or fluvoxamine did not differ from placebo in relief of mild to moderate COVID symptoms or number of hospital admissions or emergency room visits. ACTIV-6 is now studying a moderate dose of fluvoxamine (100 mg twice daily) and a higher dose of ivermectin (600 ug/kg daily for 6 days).
References
1. McCarthy MW. Results from ACTIV-6: a decentralized, double-blinded, randomized, placebo-controlled platform trial of repurposed drugs for the treatment of mild-to-moderate COVID-19. IDWeek 2022, October 19-23, 2022, Washington, DC. Abstract LB1528.
2. McCarthy MW. Fluvoxamine for outpatient treatment of COVID-19: a decentralized, placebo-controlled, randomized, platform clinical trial. IDWeek 2022, October 19-23, 2022, Washington, DC. Abstract LB1528A.
3. Boulware DR. Inhaled fluticasone for outpatient treatment of COVID-19: a decentralized, placebo-controlled, randomized, platform clinical trial. IDWeek 2022, October 19-23, 2022, Washington, DC. Abstract LB1528B.
4. Naggie S. Ivermectin for treatment of mild-to-moderate COVID-19 in the outpatient setting a decentralized, placebo-controlled, randomized, platform clinical trial. IDWeek 2022, October 19-23, 2022, Washington, DC. Abstract LB1528C.
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