Evidence map›Paper›PMID 34189446›Full record

ArticleEClinicalMedicine2021

Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial.

Alejandro Krolewiecki, Adrián Lifschitz, Matías Moragas, Marina Travacio, Ricardo Valentini, Daniel F Alonso, Rubén Solari, Marcelo A Tinelli, Rubén O Cimino, Luis Álvarez and 13 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. 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 NCT04381884 (A Pilot, Proof of Concept Trial to Prove Ivermectin Efficacy in the Reduction of SARS-CoV-2 Replication at Early Stages of COVID-19), which is not on this map. Cited by 48 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 8 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT04381884 phase2completednot on this map

A Pilot, Proof of Concept Trial to Prove Ivermectin Efficacy in the Reduction of SARS-CoV-2 Replication at Early Stages of COVID-19

TypeinterventionalSponsorLaboratorio Elea Phoenix S.A.Ran2020 to 2020Enrolled45ConditionsCOVID-19 Drug TreatmentArmsIVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 8 syntheses or guidelines pooled it, 99 citations in OpenAlex.

  1. Pooled it
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  3. Ivermectin for preventing and treating COVID-19.The Cochrane database of systematic reviews · 2022
    Pooled it
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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

23 authors at 8 institutions in 1 country.

Alejandro KrolewieckiInstituto de Investigaciones de Enfermedades Tropicales (IIET-CONICET), Sede Regional Orán, Universidad Nacional de Salta, Alvarado 751 (4530), Orán, Argentina.
Adrián LifschitzLaboratorio de Farmacología, CONICET-CICPBA-UNCPBA, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Centro de Investigación Veterinaria de Tandil (CIVETAN), Tandil, Argentina.
Matías MoragasUnidad de Virología y Epidemiología Molecular, Hospital de Pediatría "Prof. Dr. Juan P. Garrahan"-CONICET, Ciudad de Buenos Aires, Argentina.
Marina TravacioCátedra de Química General e Inorgánica, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Buenos Aires, Argentina.
Ricardo ValentiniDepartamento de Medicina, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
Daniel F AlonsoCentro de Oncología Molecular y Traslacional (COMTra) y Plataforma de Servicios Biotecnológicos, Departamento de Ciencia y Tecnología, Universidad Nacional de Quilmes, Buenos Aires, Argentina.
Rubén SolariHospital Francisco J. Muñiz, Buenos Aires, Argentina.
Marcelo A TinelliLaboratorio Elea/Phoenix, Los Polvorines, Argentina.
Rubén O CiminoInstituto de Investigaciones de Enfermedades Tropicales (IIET-CONICET), Sede Regional Orán, Universidad Nacional de Salta, Alvarado 751 (4530), Orán, Argentina.
Luis ÁlvarezLaboratorio de Farmacología, CONICET-CICPBA-UNCPBA, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Centro de Investigación Veterinaria de Tandil (CIVETAN), Tandil, Argentina.
Pedro E FleitasInstituto de Investigaciones de Enfermedades Tropicales (IIET-CONICET), Sede Regional Orán, Universidad Nacional de Salta, Alvarado 751 (4530), Orán, Argentina.
Laura CeballosLaboratorio de Farmacología, CONICET-CICPBA-UNCPBA, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Centro de Investigación Veterinaria de Tandil (CIVETAN), Tandil, Argentina.
Marcelo GolembaUnidad de Virología y Epidemiología Molecular, Hospital de Pediatría "Prof. Dr. Juan P. Garrahan"-CONICET, Ciudad de Buenos Aires, Argentina.
Florencia FernándezUnidad de Virología y Epidemiología Molecular, Hospital de Pediatría "Prof. Dr. Juan P. Garrahan"-CONICET, Ciudad de Buenos Aires, Argentina.
Diego Fernández de OliveiraDepartamento de Medicina, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
German AstudilloHospital Francisco J. Muñiz, Buenos Aires, Argentina.
Inés BaeckDepartamento de Medicina, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
Javier FarinaServicio de Infectología, Hospital Cuenca Alta, Cañuelas, Argentina.
Georgina A CardamaCentro de Oncología Molecular y Traslacional (COMTra) y Plataforma de Servicios Biotecnológicos, Departamento de Ciencia y Tecnología, Universidad Nacional de Quilmes, Buenos Aires, Argentina.
Andrea ManganoUnidad de Virología y Epidemiología Molecular, Hospital de Pediatría "Prof. Dr. Juan P. Garrahan"-CONICET, Ciudad de Buenos Aires, Argentina.
Eduardo SpitzerLaboratorio Elea/Phoenix, Los Polvorines, Argentina.
Silvia GoldFundación Mundo Sano, Buenos Aires, Argentina.
Carlos LanusseLaboratorio de Farmacología, CONICET-CICPBA-UNCPBA, Facultad de Ciencias Veterinarias, Universidad Nacional del Centro de la Provincia de Buenos Aires, Centro de Investigación Veterinaria de Tandil (CIVETAN), Tandil, Argentina.
Consejo Nacional de Investigaciones Científicas y Técnicas · ARCentro de Educación Médica e Investigaciones Clínicas Norberto Quirno · ARNational University of Salta · ARElea (Argentina) · ARHospital Muñiz · ARNational University of Quilmes · ARFundación Pro Salud y Medio Ambiente · ARUniversidad de Buenos Aires · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are limited antiviral options for the treatment of patients with COVID-19. Ivermectin (IVM), a macrocyclic lactone with a wide anti-parasitary spectrum, has shown potent activity against SARS-CoV-2

methodsProof-of-concept, pilot, randomized, controlled, outcome-assessor blinded trial to evaluate antiviral activity of high-dose IVM in 45 COVID-19 hospitalized patients randomized in a 2:1 ratio to standard of care plus oral IVM at 0·6 mg/kg/day for 5 days versus standard of care in 4 hospitals in Argentina. Eligible patients were adults with RT-PCR confirmed SARS-CoV-2 infection within 5 days of symptoms onset. The primary endpoint was the difference in viral load in respiratory secretions between baseline and day-5, by quantitative RT-PCR. Concentrations of IVM in plasma were measured. Study registered at ClinicalTrials.gov: NCT04381884.

findings45 participants were recruited (30 to IVM and 15 controls) between May 18 and September 9, 2020. There was no difference in viral load reduction between groups but a significant difference was found in patients with higher median plasma IVM levels (72% IQR 59-77) versus untreated controls (42% IQR 31-73) (

interpretationA concentration dependent antiviral activity of oral high-dose IVM was identified at a dosing regimen that was well tolerated. Large trials with clinical endpoints are necessary to determine the clinical utility of IVM in COVID-19.

fundingThis work was supported by grant IP-COVID-19-625, Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación, Argentina and Laboratorio ELEA/Phoenix, Argentina.

Identifiers

PMID34189446
PMCPMC8225706
OpenAlexW3170319714

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.