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The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages : A Systematic Review of Global Trial Registries Dillman, Alison; Zoratti, Michael J.; Park, Jay J. H.; Hsu, Grace; Dron, Louis; Smith, Gerald; Harari, Ofir; Rayner, Craig R.; Zannat, Noor-E; Gupta, Alind; Mackay, Eric; Arora, Paul; Lee, Zelyn; Mills, Edward J.

Abstract

Purpose: A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The purpose of this review was to describe the emerging evidence base of COVID-19 RCTs by stages of disease progression, from pre-exposure to hospitalization. Methods: We collated trial data across international registries: ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Registry; Chinese Clinical Trial Registry; Clinical Research Information Service; EU Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; German Clinical Trials Register (up to 7 October 2020). Active COVID-19 RCTs in international registries were eligible for inclusion. We extracted trial status, intervention(s), control, sample size, and clinical context to generate descriptive frequencies, network diagram illustrations, and statistical analyses including odds ratios and the Mann–Whitney U-test. Results: Our search identified 11503 clinical trials registered for COVID-19 and identified 2388 RCTs. After excluding 45 suspended RCTs and 480 trials with unclear or unreported disease stages, 1863 active RCTs were included and categorized into four broad disease stages: pre-exposure (n=107); post-exposure (n=208); outpatient treatment (n=266); hospitalization, including the intensive care unit (n=1376). Across all disease stages, most trials had two arms (n=1500/1863, 80.52%), most often included (hydroxy)chloroquine (n=271/ 1863, 14.55%) and were US-based (n=408/1863, 21.90%). US-based trials had lower odds of including (hydroxy)chloroquine than trials in other countries (OR: 0.63, 95% CI: 0.45–0.90) and similar odds of having two arms compared to other geographic regions (OR: 1.05, 95% CI: 0.80–1.38). Conclusion: There is a marked difference in the number of trials across settings, with limited studies on non-hospitalized persons. Focus on pre- and post-exposure, and outpatients, is worthwhile as a means of reducing infections and lessening the health, social, and economic burden of COVID-19.

Item Metadata

Title
The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages : A Systematic Review of Global Trial Registries
Creator
Dillman, Alison; Zoratti, Michael J.; Park, Jay J. H.; Hsu, Grace; Dron, Louis; Smith, Gerald; Harari, Ofir; Rayner, Craig R.; Zannat, Noor-E; Gupta, Alind; Mackay, Eric; Arora, Paul; Lee, Zelyn; Mills, Edward J.
Publisher
Dove Medical Press
Date Issued
2020
Description
Purpose: A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The purpose of this review was to describe the emerging evidence base of COVID-19 RCTs by stages of disease progression, from pre-exposure to hospitalization. Methods: We collated trial data across international registries: ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Registry; Chinese Clinical Trial Registry; Clinical Research Information Service; EU Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; German Clinical Trials Register (up to 7 October 2020). Active COVID-19 RCTs in international registries were eligible for inclusion. We extracted trial status, intervention(s), control, sample size, and clinical context to generate descriptive frequencies, network diagram illustrations, and statistical analyses including odds ratios and the Mann–Whitney U-test. Results: Our search identified 11503 clinical trials registered for COVID-19 and identified 2388 RCTs. After excluding 45 suspended RCTs and 480 trials with unclear or unreported disease stages, 1863 active RCTs were included and categorized into four broad disease stages: pre-exposure (n=107); post-exposure (n=208); outpatient treatment (n=266); hospitalization, including the intensive care unit (n=1376). Across all disease stages, most trials had two arms (n=1500/1863, 80.52%), most often included (hydroxy)chloroquine (n=271/ 1863, 14.55%) and were US-based (n=408/1863, 21.90%). US-based trials had lower odds of including (hydroxy)chloroquine than trials in other countries (OR: 0.63, 95% CI: 0.45–0.90) and similar odds of having two arms compared to other geographic regions (OR: 1.05, 95% CI: 0.80–1.38). Conclusion: There is a marked difference in the number of trials across settings, with limited studies on non-hospitalized persons. Focus on pre- and post-exposure, and outpatients, is worthwhile as a means of reducing infections and lessening the health, social, and economic burden of COVID-19.
Subject
COVID-19; Novel coronavirus 2019; Systematic review; Randomized controlled trials
Genre
Article
Type
Text
Language
eng
Date Available
2021-07-07
Provider
Vancouver : University of British Columbia Library
Rights
Attribution-NonCommercial 4.0 International
DOI
10.14288/1.0400055
URI
http://hdl.handle.net/2429/78866
Affiliation
Medicine, Faculty of; Non UBC; Medicine, Department of
Campus
UBCV
Citation
Dillman, A., Zoratti, M. J., Park, J. J. H., Hsu, G., Dron, L., Smith, G., Harari, O., Rayner, C. R., Zannat, N., Gupta, A., Mackay, E., Arora, P., Lee, Z., & Mills, E. J. (2020). The landscape of emerging randomized clinical trial evidence for COVID-19 disease stages: A systematic review of global trial registries. Infection and Drug Resistance, 13, 4577-4587.
Publisher DOI
10.2147/IDR.S288399
Peer Review Status
Reviewed
Scholarly Level
Faculty; Researcher; Graduate; Undergraduate
Copyright Holder
Authors
Rights URI
http://creativecommons.org/licenses/by-nc/4.0/
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Attribution-NonCommercial 4.0 International