Evidence map›Paper›PMID 37283627›Full record

ArticleFrontiers in medicine2023

Efficacy and safety of single-dose ivermectin in mild-to-moderate COVID-19: the double-blind, randomized, placebo-controlled CORVETTE-01 trial.

Tatsuhiko Wada, Makoto Hibino, Hiromi Aono, Shunsuke Kyoda, Yosuke Iwadate, Eri Shishido, Keisuke Ikeda, Nana Kinoshita, Yasuki Matsuda, Sakiko Otani and 16 more

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in medicine, 2023. 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 NCT04703205 (A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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.

NCT04703205 phase2unknown statusnot on this map

A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial

TypeinterventionalSponsorKitasato UniversityRan2020 to 2022Enrolled214ConditionsCovid19ArmsIvermectin 3 MG, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Tatsuhiko WadaDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Makoto HibinoDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Hiromi AonoDepartment of Respiratory Medicine, Tokyo Metropolitan Police Hospital, Tokyo, Japan.
Shunsuke KyodaDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Yosuke IwadateDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Eri ShishidoDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Keisuke IkedaDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Nana KinoshitaDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
Yasuki MatsudaDepartment of Cardiovascular Medicine, Kitasato University Hospital, Kanagawa, Japan.
Sakiko OtaniDepartment of Respiratory Medicine, Kitasato University Hospital, Kanagawa, Japan.
Ryo KamedaDepartment of Cardiovascular Medicine, Kitasato University Hospital, Kanagawa, Japan.
Kenta MatobaDepartment of Endocrinology and Metabolism, Kitasato University Hospital, Kanagawa, Japan.
Miwa NonakaGlobal Clinical Research Coordinating Center, Kitasato University Hospital, Kanagawa, Japan.
Mika MaedaLaboratory of Clinical Pharmacoepidemiology and Research and Education Center for Clinical Pharmacy, School of Pharmacy, Kitasato University, Kanagawa, Japan.
Yuji KumagaiClinical Trial Center, Kitasato University Hospital, Kanagawa, Japan.
Junya AkoDepartment of Cardiovascular Medicine, Kitasato University Hospital, Kanagawa, Japan.
Masayoshi ShichiriDepartment of Diabetes, Endocrinology and Metabolism, Tokyo Kyosai Hospital, Tokyo, Japan.
Katsuhiko NaokiDepartment of Respiratory Medicine, Kitasato University Hospital, Kanagawa, Japan.
Masato KatagiriDepartment of Medical Laboratory Sciences, Kitasato University School of Allied Health Sciences, Tokyo, Japan.
Masashi TakasoDepartment of Orthopedic Surgery, Kitasato University Hospital, Kanagawa, Japan.
Masatsugu IwamuraDepartment of Urology, Kitasato University Hospital, Kanagawa, Japan.
Kazuhiko KatayamaDepartment of Infection Control and Immunology, Ōmura Satoshi Memorial Institute, Tokyo, Japan.
Takeshi MiyatsukaDepartment of Endocrinology and Metabolism, Kitasato University Hospital, Kanagawa, Japan.
Yasushi OrihashiDivision of Clinical Research, Kitasato University Hospital, Kanagawa, Japan.
Kunihiro YamaokaDepartment of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Kanagawa, Japan.
CORVETTE-01 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: To investigate whether ivermectin inhibits SARS-CoV-2 proliferation in patients with mild-to-moderate COVID-19 using time to a negative COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) test. Methods: CORVETTE-01 was a double-blind, randomized, placebo-controlled study (August 2020-October 2021) conducted in Japan. Overall, 248 patients diagnosed with COVID-19 using RT-PCR were assessed for eligibility. A single oral dose of ivermectin (200  μg/kg) or placebo was administered under fasting. The primary outcome was time to a negative COVID-19 RT-PCR test result for SARS-CoV-2 nucleic acid, assessed using stratified log-rank test and Cox regression models. Results: Overall, 112 and 109 patients were randomized to ivermectin and placebo, respectively; 106 patients from each group were included in the full analysis set (male [%], mean age: 68.9%, 47.9 years [ivermectin]; 62.3%, 47.5 years [placebo]). No significant difference was observed in the occurrence of negative RT-PCR tests between the groups (hazard ratio, 0.96; 95% confidence interval [CI] 0.70-1.32; Conclusion: In patients with COVID-19, single-dose ivermectin was ineffective in decreasing the time to a negative RT-PCR test. Clinical Trial Registration: ClinicalTrials.gov, NCT04703205.

Indexed as

double-blindivermectinJapanRT-PCR testSARS-CoV-2 proliferation

Identifiers

PMID37283627
PMCPMC10240959

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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.