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10-1007-s11606-021-07167-9 |
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220420s2022 CNT 000 0 und d |
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|a 08848734 (ISSN)
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|a The Landscape of COVID-19 Research in the United States: a Cross-sectional Study of Randomized Trials Registered on ClinicalTrials.Gov
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|b Springer
|c 2022
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|a 8
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|z View Fulltext in Publisher
|u https://doi.org/10.1007/s11606-021-07167-9
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|a Importance: SARS-CoV-2 has infected over 200 million people worldwide, resulting in more than 4 million deaths. Randomized controlled trials are the single best tool to identify effective treatments against this novel pathogen. Objective: To describe the characteristics of randomized controlled trials of treatments for COVID-19 in the United States launched in the first 9 months of the pandemic. Design, Setting, and Participants We conducted a cross-sectional study of all completed or actively enrolling randomized, interventional, clinical trials for the treatment of COVID-19 in the United States registered on www.clinicaltrials.gov as of August 10, 2020. We excluded trials of vaccines and other interventions intended to prevent COVID-19. Main Outcomes and Measures We used descriptive statistics to characterize the clinical trials and the statistical power for the available studies. For the late-phase trials (i.e., phase 3 and 2/3 studies), we compared the geographic distribution of the clinical trials with the geographic distribution of people diagnosed with COVID-19. Results: We identified 200 randomized controlled trials of treatments for people with COVID-19. Across all trials, 87 (43.5%) were single-center, 64 (32.0%) were unblinded, and 80 (40.0%) were sponsored by industry. The most common treatments included monoclonal antibodies (N=46 trials), small molecule immunomodulators (N=28), antiviral medications (N=24 trials), and hydroxychloroquine (N=20 trials). Of the 9 trials completed by August 2020, the median sample size was 450 (IQR 67–1113); of the 191 ongoing trials, the median planned sample size was 150 (IQR 60–400). Of the late-phase trials (N=54), the most common primary outcome was a severity scale (N=23, 42.6%), followed by a composite of mortality and ventilation (N=10, 18.5%), and mortality alone (N=6, 11.1%). Among these late-phase trials, all trials of antivirals, monoclonal antibodies, or chloroquine/hydroxychloroquine had a power of less than 25% to detect a 20% relative risk reduction in mortality. Had the individual trials for a given class of treatments instead formed a single trial, the power to detect that same reduction in mortality would have been greater than 98%. There was large variability in access to trials with the highest number of trials per capita in the Northeast and the lowest in the Midwest. Conclusions and Relevance: A large number of randomized trials were launched early in the pandemic to evaluate treatments for COVID-19. However, many trials were underpowered for important clinical endpoints and substantial geographic disparities were observed, highlighting the importance of improving national clinical trial infrastructure. © 2021, Society of General Internal Medicine.
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|a adult
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|a aged
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|a anticoagulant agent
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|a antivirus agent
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|a Article
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|a artificial ventilation
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|a chloroquine
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|a controlled study
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|a coronavirus disease 2019
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|a COVID-19
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|a Cross-Sectional Studies
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|a cross-sectional study
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|a dipeptidyl carboxypeptidase inhibitor
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|a epidemiology
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|a geographic distribution
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|a human
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|a Humans
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|a hydroxychloroquine
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|a immunomodulating agent
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|a major clinical study
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|a medical research
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|a monoclonal antibody
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|a mortality
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|a oxygen
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|a pandemic
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|a Pandemics
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|a phase 1 clinical trial (topic)
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|a phase 2 clinical trial (topic)
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|a phase 3 clinical trial (topic)
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|a phase 4 clinical trial (topic)
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|a polyclonal antibody
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|a randomized controlled trial (topic)
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|a randomized controlled trial (topic)
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|a Randomized Controlled Trials as Topic
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|a risk factor
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|a risk reduction
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|a sample size
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|a SARS-CoV-2
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|a treatment outcome
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|a Treatment Outcome
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|a United States
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|a United States
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|a Campbell, K.R.
|e author
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|a Dougan, M.
|e author
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|a Fralick, M.
|e author
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|a Moggridge, J.
|e author
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|a North, C.M.
|e author
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|a Sacks, C.A.
|e author
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|a Wolf, M.
|e author
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|t Journal of General Internal Medicine
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