Effect of Ivermectin vs Placebo on Sustained Recovery in Outpatients with Mild to Moderate COVID-19
JAMA: The Journal of the American Medical Association: Published on
November, 2022
Despite advances in treatment of
COVID-19, additional therapies are needed, particularly in the outpatient
setting. Novel oral antivirals have been authorized for high-risk individuals. Numerous
repurposed drugs have been investigated for COVID-19.
Ivermectin, an antiparasitic drug
used worldwide for onchocerciasis and strongyloidiasis, emerged in 2020 as a
potential repurposed drug for COVID-19 due to an in vitro study suggesting
possible antiviral activity.
Although there are numerous
published studies reporting on the potential efficacy of ivermectin for the
treatment of COVID-19, many are in the inpatient setting and the majority are
small, variable in population and dosing, and some have been retracted.
The authors of this double-blind,
randomized, placebo-controlled platform trial evaluated the effect of
ivermectin on clinical outcomes in outpatients with mild to moderate COVID-19
infection.
TAKE-HOME MESSAGE
This article reports the effect of
ivermectin, 400 μg/kg, daily for 3 days, compared with placebo, for the
treatment of early mild to moderate COVID-19.
Authors determined that there was
no significant difference in the median time to recovery between the ivermectin
and placebo groups. The rate of hospitalizations and deaths did not differ
significantly between the two groups.
In the outpatient setting, larger
well-designed trials such as the current trial are emerging and do not support
a clinical benefit of ivermectin when used at a dose of 400 μg/kg daily for 3
days. Thus, this study adds to the growing evidence that there is not a
clinically relevant treatment effect of ivermectin at this dose and duration.
The results of this study add to
the body of evidence suggesting that the use of ivermectin does not confer any
clinical benefits in outpatients with mild to moderate COVID-19.
A lack of treatment effect was also
seen for secondary clinical outcomes including hospitalization, death, or acute
care visits. These findings do not support the use of ivermectin in patients
with mild to moderate COVID-19.
Conclusions
Among outpatients with mild to moderate COVID-19, treatment with
ivermectin, compared with placebo, did not significantly improve time to
recovery.
These findings do not support the use of ivermectin in patients with mild to moderate COVID-19.
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IMPORTANCE
The effectiveness of ivermectin to
shorten symptom duration or prevent hospitalization among outpatients in the US
with mild to moderate symptomatic COVID-19 is unknown.
OBJECTIVE
To evaluate the efficacy of
ivermectin, 400 μg/kg, daily for 3 days compared with placebo for the treatment
of early mild to moderate COVID-19.
DESIGN, SETTING, AND PARTICIPANTS
ACTIV-6, an ongoing, decentralized,
double-blind, randomized, placebo-controlled platform trial, was designed to
evaluate repurposed therapies in outpatients with mild to moderate COVID-19. A
total of 1591 participants aged 30 years and older with confirmed COVID-19,
experiencing 2 or more symptoms of acute infection for 7 days or less, were
enrolled from June 23, 2021, through February 4, 2022, with follow-up data
through May 31, 2022, at 93 sites in the US.
INTERVENTIONS
Participants were randomized to
receive ivermectin, 400 μg/kg (n = 817), daily for 3 days or placebo (n = 774).
MAIN OUTCOMES AND MEASURES
Time to sustained recovery, defined
as at least 3 consecutive days without symptoms. There were 7 secondary
outcomes, including a composite of hospitalization or death by day 28.
RESULTS
Among 1800 participants who were
randomized (mean [SD] age, 48 [12] years; 932 women [58.6%]; 753 [47.3%]
reported receiving at least 2 doses of a SARS-CoV-2 vaccine), 1591 completed
the trial. The hazard ratio (HR) for improvement in time to recovery was 1.07.
The median time to recovery was 12 days in the ivermectin group and 13 days in the placebo group. There were 10
hospitalizations or deaths in the ivermectin group and 9 in the placebo group.
The most common serious adverse events were COVID-19 pneumonia (ivermectin
[n = 5]; placebo [n = 7]) and venous thromboembolism (ivermectin [n = 1];
placebo [n = 5]).
CONCLUSIONS AND RELEVANCE
Among outpatients with mild to
moderate COVID-19, treatment with ivermectin, compared with placebo, did not
significantly improve time to recovery. These findings do not support the use
of ivermectin in patients with mild to moderate COVID-19.
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