Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019: An Open-Label, Randomized Controlled Adaptive Platform Trial (PLATCOV)
Issued Date
2023-11-11
Resource Type
eISSN
15376613
Scopus ID
2-s2.0-85172941228
Pubmed ID
37470445
Journal Title
The Journal of infectious diseases
Volume
228
Issue
10
Start Page
1318
End Page
1325
Rights Holder(s)
SCOPUS
Bibliographic Citation
The Journal of infectious diseases Vol.228 No.10 (2023) , 1318-1325
Suggested Citation
Jittamala P., Schilling W.H.K., Watson J.A., Luvira V., Siripoon T., Ngamprasertchai T., Almeida P.J., Ekkapongpisit M., Cruz C., Callery J.J., Boyd S., Anunsittichai O., Hongsuwan M., Singhaboot Y., Pagornrat W., Tuntipaiboontana R., Kruabkontho V., Ngernseng T., Tubprasert J., Abdad M.Y., Keayarsa S., Madmanee W., Aguiar R.S., Santos F.M., Batty E.M., Hanboonkunupakarn P., Hanboonkunupakarn B., Sookprome S., Poovorawan K., Imwong M., Taylor W.R.J., Chotivanich V., Sangketchon C., Ruksakul W., Chotivanich K., Pukrittayakamee S., Dondorp A.M., Day N.P.J., Teixeira M.M., Piyaphanee W., Phumratanaprapin W., White N.J. Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019: An Open-Label, Randomized Controlled Adaptive Platform Trial (PLATCOV). The Journal of infectious diseases Vol.228 No.10 (2023) , 1318-1325. 1325. doi:10.1093/infdis/jiad275 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/91189
Title
Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019: An Open-Label, Randomized Controlled Adaptive Platform Trial (PLATCOV)
Author(s)
Jittamala P.
Schilling W.H.K.
Watson J.A.
Luvira V.
Siripoon T.
Ngamprasertchai T.
Almeida P.J.
Ekkapongpisit M.
Cruz C.
Callery J.J.
Boyd S.
Anunsittichai O.
Hongsuwan M.
Singhaboot Y.
Pagornrat W.
Tuntipaiboontana R.
Kruabkontho V.
Ngernseng T.
Tubprasert J.
Abdad M.Y.
Keayarsa S.
Madmanee W.
Aguiar R.S.
Santos F.M.
Batty E.M.
Hanboonkunupakarn P.
Hanboonkunupakarn B.
Sookprome S.
Poovorawan K.
Imwong M.
Taylor W.R.J.
Chotivanich V.
Sangketchon C.
Ruksakul W.
Chotivanich K.
Pukrittayakamee S.
Dondorp A.M.
Day N.P.J.
Teixeira M.M.
Piyaphanee W.
Phumratanaprapin W.
White N.J.
Schilling W.H.K.
Watson J.A.
Luvira V.
Siripoon T.
Ngamprasertchai T.
Almeida P.J.
Ekkapongpisit M.
Cruz C.
Callery J.J.
Boyd S.
Anunsittichai O.
Hongsuwan M.
Singhaboot Y.
Pagornrat W.
Tuntipaiboontana R.
Kruabkontho V.
Ngernseng T.
Tubprasert J.
Abdad M.Y.
Keayarsa S.
Madmanee W.
Aguiar R.S.
Santos F.M.
Batty E.M.
Hanboonkunupakarn P.
Hanboonkunupakarn B.
Sookprome S.
Poovorawan K.
Imwong M.
Taylor W.R.J.
Chotivanich V.
Sangketchon C.
Ruksakul W.
Chotivanich K.
Pukrittayakamee S.
Dondorp A.M.
Day N.P.J.
Teixeira M.M.
Piyaphanee W.
Phumratanaprapin W.
White N.J.
Other Contributor(s)
Abstract
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.