Evidence map›Paper›PMID 34999239›Full record

Trial reportInternational journal of antimicrobial agents2022

High-dose ivermectin for early treatment of COVID-19 (COVER study): a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial.

Dora Buonfrate, Fabio Chesini, Davide Martini, Maria Carla Roncaglioni, Maria Luisa Ojeda Fernandez, Maria Francesca Alvisi, Irene De Simone, Eliana Rulli, Alessandro Nobili, Giacomo Casalini and 8 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of antimicrobial agents, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

33 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Ivermectin for preventing and treating COVID-19.The Cochrane database of systematic reviews · 2022
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  6. Is Ivermectin Effective in Treating COVID-19?Frontiers in pharmacology · 2022
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Dora BuonfrateDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy. Electronic address: dora.buonfrate@sacrocuore.it.
Fabio ChesiniDipartimento ad attività integrata medico-generale, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.
Davide MartiniDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.
Maria Carla RoncaglioniDepartment of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Maria Luisa Ojeda FernandezDepartment of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Maria Francesca AlvisiDepartment of Oncology, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Irene De SimoneDepartment of Oncology, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Eliana RulliDepartment of Oncology, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Alessandro NobiliDepartment of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Giacomo CasaliniDipartimento di Scienze Biomediche e Cliniche 'Luigi Sacco', Università degli Studi di Milano, Milan, Italy.
Spinello AntinoriDipartimento di Scienze Biomediche e Cliniche 'Luigi Sacco', Università degli Studi di Milano, Milan, Italy.
Marco GobbiDepartment of Biochemistry and Molecular Pharmacology, Istituto di Ricerche Farmacologiche Mario Negri-IRCCS, Milan, Italy.
Caterina CampoliInfectious Disease Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Michela DeianaDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.
Elena PomariDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.
Gianluigi LunardiClinical Analysis Laboratory and Transfusional Medicine, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.
Roberto TessariHospital Pharmacy, IRCCS Sacro Cuore-Don Calabria hospital, Negrar di Valpolicella, Verona, Italy.
Zeno BisoffiDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore-Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

High concentrations of ivermectin demonstrated antiviral activity against SARS-CoV-2 in vitro. The aim of this study was to assess the safety and efficacy of high-dose ivermectin in reducing viral load in individuals with early SARS-CoV-2 infection. This was a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial. Participants were adults recently diagnosed with asymptomatic/oligosymptomatic SARS-CoV-2 infection. Exclusion criteria were: pregnant or lactating women; CNS disease; dialysis; severe medical condition with prognosis <6 months; warfarin treatment; and antiviral/chloroquine phosphate/hydroxychloroquine treatment. Participants were assigned (ratio 1:1:1) according to a randomised permuted block procedure to one of the following arms: placebo (arm A); single-dose ivermectin 600 μg/kg plus placebo for 5 days (arm B); and single-dose ivermectin 1200 μg/kg for 5 days (arm C). Primary outcomes were serious adverse drug reactions (SADRs) and change in viral load at Day 7. From 31 July 2020 to 26 May 2021, 32 participants were randomised to arm A, 29 to arm B and 32 to arm C. Recruitment was stopped on 10 June because of a dramatic drop in cases. The safety analysis included 89 participants and the change in viral load was calculated in 87 participants. No SADRs were registered. Mean (S.D.) log

Indexed as

COVID-19 Drug TreatmentAdultAntiparasitic AgentsAntiviral AgentsCOVID-19Double-Blind MethodDrug RepositioningFemaleHumansIvermectinMaleMiddle AgedSARS-CoV-2Treatment OutcomeViral LoadAntiparasitic AgentsAntiviral AgentsIvermectinCOVID-19IvermectinRandomised controlled trialSARS-CoV-2

Identifiers

PMID34999239
PMCPMC8734085

What OpenQuestion holds

Textmetadata
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.