Evidence map›Paper›PMID 32948577›Full record

ArticleBMJ open2020

Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis.

Christopher W Jones, Ashley L Woodford, Timothy F Platts-Mills

Abstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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.

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

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

  1. Pooled it
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  9. Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
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  10. Review
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  15. Clinical research methodology process: what is changing with COVID-19?European heart journal supplements : journal of the European Society of Cardiology · 2021
    Article
  16. One year on: The impact of COVID-19 on clinical research.European journal of internal medicine · 2021
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  18. Article
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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

3 authors.

Christopher W JonesEmergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA jones-christopher@cooperhealth.edu.ORCID 0000-0001-9704-9094
Ashley L WoodfordEmergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
Timothy F Platts-MillsEmergency Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo characterise current COVID-19-related research activities.

designCross-sectional analysis.

settingClinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19. DATA SOURCES: ClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic.

main outcome measuresWe classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date.

resultsOf the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020.

conclusionsThese findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.

Indexed as

Clinical Trials as TopicRegistriesStem Cell TransplantationAntibodies, Monoclonal, HumanizedAntiviral AgentsAzithromycinBetacoronavirusChloroquineCoronavirus InfectionsCOVID-19COVID-19 Drug TreatmentCOVID-19 SerotherapyDouble-Blind MethodDrug CombinationsHumansHydroxychloroquineAntibodies, Monoclonal, HumanizedAntiviral AgentsAzithromycinChloroquineDrug CombinationsHydroxychloroquineLopinavirlopinavir-ritonavir drug combinationRitonavirtocilizumabclinical trialsstatistics & research methodsvirology

Identifiers

PMID32948577
PMCPMC7500290

What OpenQuestion holds

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LicenceCC BY-NC
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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.