Ivermectin unable to significantly trim the time to recovery in COVID-19 patients: JAMA
A new trial conducted in the US found that Ivermectin could not reduce the time to recovery in mild-to-moderate COVID-19 patients when compared with a placebo. The trial results were published in the journal JAMA Network.
COVID-19 has stirred a chaotic environment worldwide. Despite advanced therapeutic options, the requirement for additional options has become necessary for the outpatient setting. Ivermectin, an antiparasitic drug, has reemerged as a potential repurposed drug for COVID-19 in recent times but 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. Hence researchers in the US conducted a decentralized, double-blind, randomized, placebo-controlled platform trial called the ACTIV-6 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.
From June 23, 2021, to February 4, 2022, at 93 sites in the United States, a total of 1591 participants aged 30 and older with confirmed COVID-19 and experiencing two or more symptoms of acute infection for less than seven days were enrolled. The follow-up data was available until May 31, 2022. Ivermectin at 400 mg/kg or placebo was randomly assigned to each participant over three days. There were 817 participants in the Ivermectin group and 774 participants in the placebo group. The main outcome of measurement was the time to sustained recovery, which is defined as having no symptoms for at least three consecutive days. Seven secondary outcomes were present, one of which was a composite of hospitalization or death on day 28.
Trial findings:
- Among 1800 randomized participants, 1591 completed the trial
- The mean [SD] age of the participants was 48 [12] years. There were 932 women [58.6%] in total. 753 [47.3%] reported receiving at least 2 doses of a SARS-CoV-2 vaccine.
- The hazard ratio (HR) for improvement in time to recovery was 1.07.
- The median time to recovery was 12 days (IQR, 11-13) in the ivermectin group and 13 days (IQR, 12-14) in the placebo group.
- In the ivermectin group, there were 10 hospitalizations or deaths and in the placebo group, there were 9 (1.2% vs 1.2%).
- COVID-19 pneumonia (ivermectin [n = 5]; placebo [n = 7]) and venous thromboembolism (ivermectin [n = 1]; placebo [n = 5]) were the most common serious adverse events.
As there was no significant difference in the time to recovery in the Ivermectin and placebo group, the trial did not support the usage of the drug for mild to moderate COVID-19.
Further reading: 10.1001/jama.2022.18590
Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022;328(16):1595–1603.
