Evidence map›Paper›PMID 38431155›Full record

Trial reportThe Journal of infection2024

Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes.

Gail Hayward, Ly-Mee Yu, Paul Little, Oghenekome Gbinigie, Milensu Shanyinde, Victoria Harris, Jienchi Dorward, Benjamin R Saville, Nicholas Berry, Philip H Evans and 16 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyAdaptive Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infection, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  10. Ivermectin and gynecologic cancer: What's the data?Gynecologic oncology reports · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 7 institutions in 3 countries.

Gail HaywardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Ly-Mee YuNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Paul LittlePrimary Care Research Centre, University of Southampton, Southampton, UK.
Oghenekome GbinigieNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Milensu ShanyindeNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Victoria HarrisNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Jienchi DorwardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Benjamin R SavilleBerry Consultants, TX, USA; Department of Biostatistics, Vanderbilt University School of Medicine, TN, USA.
Nicholas BerryBerry Consultants, TX, USA.
Philip H EvansCollege of Medicine and Health, University of Exeter, Exeter, UK; National Institute for Health Research (NIHR) Clinical Research Network, National Institute for Health Research, London, UK.
Nicholas P B ThomasNational Institute for Health Research (NIHR) Clinical Research Network, National Institute for Health Research, London, UK.
Mahendra G PatelNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Duncan RichardsRoyal College of General Practitioners, London, UK; Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK.
Oliver V HeckeNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Michelle A DetryBerry Consultants, TX, USA.
Christina SaundersBerry Consultants, TX, USA.
Mark FitzgeraldBerry Consultants, TX, USA.
Jared RobinsonNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Charlotte Latimer-BellNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Julie AllenNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Emma OgburnNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Jenna GrabeyNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Simon de LusignanNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Fd Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: principle@phc.ox.ac.uk.
Christopher C ButlerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: principle@phc.ox.ac.uk.
PRINCIPLE Trial Collaborative Group
University of Oxford · GBBerry & Associates (United States) · USCentre for the AIDS Programme of Research in South Africa · ZANational Institute for Health Research · GBNIHR Southampton Biomedical Research Centre · GBUniversity of Exeter · GBVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe evidence for whether ivermectin impacts recovery, hospital admissions, and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in the context of clinical trials.

methodsIn this multicentre, open-label, multi-arm, adaptive platform randomised controlled trial, we included participants aged ≥18 years in the community, with a positive SARS-CoV-2 test, and symptoms lasting ≤14 days. Participants were randomised to usual care, usual care plus ivermectin tablets (target 300-400 μg/kg per dose, once daily for 3 days), or usual care plus other interventions. Co-primary endpoints were time to first self-reported recovery, and COVID-19 related hospitalisation/death within 28 days, analysed using Bayesian models. Recovery at 6 months was the primary, longer term outcome.

trial registrationISRCTN86534580.

findingsThe primary analysis included 8811 SARS-CoV-2 positive participants (median symptom duration 5 days), randomised to ivermectin (n = 2157), usual care (n = 3256), and other treatments (n = 3398) from June 23, 2021 to July 1, 2022. Time to self-reported recovery was shorter in the ivermectin group compared with usual care (hazard ratio 1·15 [95% Bayesian credible interval, 1·07 to 1·23], median decrease 2.06 days [1·00 to 3·06]), probability of meaningful effect (pre-specified hazard ratio ≥1.2) 0·192). COVID-19-related hospitalisations/deaths (odds ratio 1·02 [0·63 to 1·62]; estimated percentage difference 0% [-1% to 0·6%]), serious adverse events (three and five respectively), and the proportion feeling fully recovered were similar in both groups at 6 months (74·3% and 71·2% respectively (RR = 1·05, [1·02 to 1·08]) and also at 3 and 12 months.

interpretationIvermectin for COVID-19 is unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer-term outcomes. Further trials of ivermectin for SARS-Cov-2 infection in vaccinated community populations appear unwarranted.

fundingUKRI/National Institute of Health Research (MC_PC_19079).

Indexed as

COVID-19AdolescentAdultBayes TheoremHumansIvermectinSARS-CoV-2Treatment OutcomeIvermectinClinical trialCOVID-19IvermectinLong-term follow upSARS-Cov2

Identifiers

PMID38431155
PMCPMC10981761
OpenAlexW4392303143

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.