Journal article
Clinical antiviral efficacy of remdesivir in coronavirus disease 2019: an open-label, randomized controlled adaptive platform trial (PLATCOV)
- Abstract:
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Background
Uncertainty over the therapeutic benefit of parenteral remdesivir in coronavirus disease 2019 (COVID-19) has resulted in varying treatment guidelines.
Methods
In a multicenter open-label, controlled, adaptive, pharmacometric platform trial, low-risk adult patients with early symptomatic COVID-19 were randomized to 1 of 8 treatment arms including intravenous remdesivir (200 mg followed by 100 mg daily for 5 days) or no study drug. The primary outcome was the rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) clearance (estimated under a linear model fit to the daily log10 viral densities, days 0–7) in standardized duplicate oropharyngeal swab eluates, in a modified intention-to-treat population. This ongoing adaptive trial is registered at ClinicalTrials.gov (NCT05041907).
Results
The 2 study arms enrolled 131 patients (remdesivir n = 67, no study drug n = 64) and estimated viral clearance rates from a median of 18 swab samples per patient (a total of 2356 quantitative polymerase chain reactions). Under the linear model, compared with the contemporaneous control arm (no study drug), remdesivir accelerated mean estimated viral clearance by 42% (95% credible interval, 18%–73%).
Conclusions
Parenteral remdesivir accelerates viral clearance in early symptomatic COVID-19. Pharmacometric assessment of therapeutics using the method described can determine in vivo clinical antiviral efficacy rapidly and efficiently.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 689.5KB, Terms of use)
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- Publisher copy:
- 10.1093/infdis/jiad275
Authors
- Publisher:
- Oxford University Press
- Journal:
- The Journal of Infectious Diseases More from this journal
- Volume:
- 228
- Issue:
- 10
- Pages:
- 1318–1325
- Place of publication:
- United States
- Publication date:
- 2023-07-20
- Acceptance date:
- 2023-07-19
- DOI:
- EISSN:
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1537-6613
- ISSN:
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0022-1899
- Pmid:
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37470445
- Language:
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English
- Keywords:
- Pubs id:
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1495371
- Local pid:
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pubs:1495371
- Deposit date:
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2023-08-30
Terms of use
- Copyright holder:
- Jittamala et al
- Copyright date:
- 2023
- Rights statement:
- © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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