Evidence map›Paper›PMID 34780978›Full record

ArticleJournal of clinical epidemiology2022

Many trials of hydroxychloroquine for SARS-CoV-2 were redundant and potentially unethical: an analysis of the NIH clinical trials registry.

Vignan Yogendrakumar, Brian Dewar, Michaeline McGuinty, Dar Dowlatshahi, Claire Dyason, Edmond Sh Kwok, Tim Ramsay, Hans Lund, Michel Shamy

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. The importance of meta-research in dentistry.Evidence-based dentistry · 2023
    Article
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

9 authors.

Vignan YogendrakumarDepartment of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.
Brian DewarOttawa Hospital Research Institute, University of Ottawa, Ontario, Canada. Electronic address: bdewar@ohri.ca.
Michaeline McGuintyDepartment of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.
Dar DowlatshahiDepartment of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.
Claire DyasonDepartment of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada.
Edmond Sh KwokDepartment of Emergency Medicine, The Ottawa Hospital, Ontario, Canada.
Tim RamsayOttawa Hospital Research Institute, University of Ottawa, Ontario, Canada; Ottawa Methods Center, University of Ottawa, Ontario, Canada.
Hans LundSection of Evidence-Based Practice, Western Norway University of Applied Sciences, Bergen, Norway.
Michel ShamyDepartment of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. STUDY DESIGN AND

settingWe identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020.

resultsBetween February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10).

conclusionMany clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.

Indexed as

Clinical Trials as TopicCOVID-19COVID-19 Drug TreatmentHydroxychloroquineAntiviral AgentsHumansNational Institutes of Health (U.S.)RegistriesSARS-CoV-2United StatesAntiviral AgentsHydroxychloroquineClinical trial regulationCOVID-19EquipoiseHydroxychloroquineRandomized controlled trialsResearch ethics

Identifiers

PMID34780978
PMCPMC8590481

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.