Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial
| Autor: | Susanna, Naggie, David R, Boulware, Christopher J, Lindsell, Thomas G, Stewart, Nina, Gentile, Sean, Collins, Matthew William, McCarthy, Dushyantha, Jayaweera, Mario, Castro, Mark, Sulkowski, Kathleen, McTigue, Florence, Thicklin, G Michael, Felker, Adit A, Ginde, Carolyn T, Bramante, Alex J, Slandzicki, Ahab, Gabriel, Nirav S, Shah, Leslie A, Lenert, Sarah E, Dunsmore, Stacey J, Adam, Allison, DeLong, George, Hanna, April, Remaly, Rhonda, Wilder, Sybil, Wilson, Elizabeth, Shenkman, Adrian F, Hernandez, Nicole, Zaleski |
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| Rok vydání: | 2023 |
| Předmět: |
Male
Adult COVID-19 Vaccines Ivermectin Time Factors SARS-CoV-2 Drug Repositioning COVID-19 General Medicine Recovery of Function Middle Aged Article COVID-19 Drug Treatment Hospitalization Treatment Outcome Double-Blind Method Anti-Infective Agents Ambulatory Care Humans Female Original Investigation |
| Zdroj: | medRxiv JAMA |
| ISSN: | 1538-3598 |
| Popis: | ImportanceThe effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients in the US with mild to moderate symptomatic COVID-19 is unknown.ObjectiveTo 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 ParticipantsACTIV-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 91 sites in the US.InterventionsParticipants were randomized to receive ivermectin, 400 μg/kg (n = 817), daily for 3 days or placebo (n = 774).Main Outcomes and MeasuresTime 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.ResultsAmong 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 (95% credible interval [CrI], 0.96-1.17; posterior P value [HR >1] = .91). 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. There were 10 hospitalizations or deaths in the ivermectin group and 9 in the placebo group (1.2% vs 1.2%; HR, 1.1 [95% CrI, 0.4-2.6]). 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 RelevanceAmong 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.Trial RegistrationClinicalTrials.gov Identifier: NCT04885530 |
| Databáze: | OpenAIRE |
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