Which large, high‑quality randomized trials of ivermectin for COVID‑19 were completed after 2022 and what were their results?
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Executive summary
Large, well‑conducted randomized trials and platform studies published after 2022 failed to show a meaningful clinical benefit from ivermectin for treating COVID‑19: a high‑dose outpatient platform trial in JAMA found no improvement in time to sustained recovery, and the UK PRINCIPLE platform (results published 2024) stopped its ivermectin arm for futility after analyzing thousands of participants [1] [2]. Multiple systematic reviews and fact‑checks drawing on these and earlier trials conclude that randomized evidence does not support ivermectin for COVID‑19 [3] [4].
1. Major randomized trials completed and published after 2022: what they were and how big they were
The most prominent randomized trial published after 2022 was the platform randomized clinical trial reported in JAMA in March 2023 that tested higher‑dose ivermectin (targeted 600 µg/kg daily for six days) versus placebo in outpatients with early mild‑to‑moderate COVID‑19; this was a large platform effort and is explicitly described as a randomized clinical trial in JAMA [1]. Another major contribution arriving in the literature after 2022 is the PRINCIPLE adaptive platform trial from the UK, whose analysis including 8,811 SARS‑CoV‑2–positive participants across multiple arms incorporated an ivermectin comparison arm that enrolled 2,157 participants and whose ivermectin randomization was stopped on July 1, 2022 because a pre‑specified futility criterion was met; the PRINCIPLE report was published in 2024 [2]. Several large platform and multicenter randomized trials that reported results in 2022 (e.g., ACTIV‑6, NEJM trial, COVER) are frequently cited alongside these later publications in syntheses and fact checks [5] [6] [7].
2. What these trials found: the core results
The JAMA higher‑dose randomized platform trial showed no clinically meaningful benefit of six days of high‑dose ivermectin on the primary outcome of time to sustained recovery in outpatients with COVID‑19 [1]. PRINCIPLE concluded that the ivermectin arm met a futility threshold on hospitalization/death and enrollment to ivermectin was stopped, indicating no detectable benefit in the large primary‑care population studied [2]. Broad syntheses and watchdog summaries translating those and other randomized trials into plain conclusions state that multiple large, well‑conducted double‑blind randomized trials involving thousands of participants did not demonstrate meaningful clinical benefit for early outpatient treatment of COVID‑19 [3] [4].
3. How the evidence fits into broader reviews and controversies
Systematic reviews and meta‑analyses published in 2022–2024 incorporated the randomized trials and documented that higher‑quality RCTs do not support ivermectin for COVID‑19, while noting earlier controversies including study retractions and heterogeneous trial quality that complicated earlier aggregate claims [8] [9] [4]. FactCheck.org and other evidence‑synthesis outlets explicitly summarize that "from multiple, large well‑conducted, double‑blind randomized clinical trials of now thousands of participants, ivermectin has not been shown to have any meaningful clinical benefit for the early, outpatient treatment of COVID‑19" [3].
4. Caveats, gaps, and why debates persist
Despite the post‑2022 negative findings, debates persist because some smaller or earlier trials reported mixed or surrogate outcomes (like viral load) and because nonrandomized studies and a minority of lower‑quality trials—some later retracted—have been amplified on social media; systematic reviewers explicitly flag retractions and methodological flaws as sources of controversy [10] [8]. Reporting limitations in the provided sources prevent a full cataloguing here of every trial that completed after 2022; however, the available high‑quality randomized evidence published after 2022 and synthesized in major reviews and fact checks consistently finds no meaningful clinical benefit of ivermectin for COVID‑19 [1] [2] [3] [4].