Evidence map›Paper›PMID 36269852›Full record

Trial reportJAMA2022

Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial.

Susanna Naggie, David R Boulware, Christopher J Lindsell, Thomas G Stewart, Nina Gentile, Sean Collins, Matthew William McCarthy, Dushyantha Jayaweera, Mario Castro, Mark Sulkowski and 19 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled TrialAdaptive Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04885530 (ACTIV-6), which is not on this map. Cited by 54 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 6 pooled it
9.4field-weighted citation impact, top 1% 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.

NCT04885530 phase3completednot on this map

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

TypeinterventionalSponsorSusanna Naggie, MDRan2021 to 2024Enrolled10,956ConditionsCovid19ArmsIvermectin, Fluvoxamine, Fluticasone, Placebo, Montelukast
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 6 syntheses or guidelines pooled it, 94 citations in OpenAlex.

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  15. Metformin on the Presence of COVID-19 Symptoms 6 Months after Infection: The ACTIV-6 Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 17 institutions in 2 countries.

Susanna NaggieDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
David R BoulwareDivision of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis.
Christopher J LindsellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
Thomas G StewartDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
Nina GentileDepartment of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.
Sean CollinsDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
Matthew William McCarthyDepartment of Medicine, Weill Cornell Medicine, New York, New York.
Dushyantha JayaweeraDepartment of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.
Mario CastroDivision of Pulmonary, Critical Care and Sleep Medicine, University of Missouri-Kansas City School of Medicine, Kansas City, Kansas.
Mark SulkowskiDivision of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland.
Kathleen McTigueDepartment of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Florence ThicklinStakeholder Advisory Committee, Pittsburgh, Pennsylvania.
G Michael FelkerDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Adit A GindeDepartment of Emergency Medicine, University of Colorado Denver-Anschutz, Denver.
Carolyn T BramanteDivision of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis.
Alex J SlandzickiClinical Trials Center of Middle Tennessee, Franklin.
Ahab GabrielFocus Clinical Research Solutions, Charlotte, North Carolina.
Nirav S ShahNorthShore University HealthSystem, Evanston, Illinois.
Leslie A LenertDepartment of Medicine, Medical University of South Carolina, Charleston.
Sarah E DunsmoreNational Center for Advancing Translational Sciences, Bethesda, Maryland.
Stacey J AdamFoundation for the National Institutes of Health, Bethesda, Maryland.
Allison DeLongDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
George HannaBiomedical Advanced Research and Development Authority, Washington, DC.
April RemalyDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Rhonda WilderDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Sybil WilsonDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Elizabeth ShenkmanDepartment of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville.
Adrian F HernandezDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators
Institute of Accelerating Systems and Applications · GRDuke University · USUniversity of Minnesota · USVanderbilt University Medical Center · USClinical Research Solutions · USCornell University · USJohns Hopkins University · USMedical University of South Carolina · USNorthShore University HealthSystem · USUniversity of Florida Health · USUniversity of Miami · USBiomedical Advanced Research and Development Authority · USFoundation for the National Institutes of Health · USNational Center for Advancing Translational Sciences · USUniversity of Colorado Denver · USUniversity of Missouri–Kansas City · USUniversity of Pittsburgh Medical Center · US

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001608NCATS NIH HHS UL1 TR002243
6 · The paper itself

Abstract

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 (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 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

Indexed as

Anti-Infective AgentsCOVID-19COVID-19 Drug TreatmentHospitalizationIvermectinAdultAmbulatory CareCOVID-19 VaccinesDouble-Blind MethodDrug RepositioningFemaleHumansMaleMiddle AgedRecovery of FunctionSARS-CoV-2Anti-Infective AgentsCOVID-19 VaccinesIvermectin

Identifiers

PMID36269852
PMCPMC9587497
OpenAlexW4307043809

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.