Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

BACKGROUND: Uncertainty over the therapeutic benefit provided by parenteral remdesivir in 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 one of eight treatment arms including intravenous remdesivir (200 mg followed by 100 mg daily for five days) or no study drug. The primary outcome was the rate of viral 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 (mITT). This ongoing adaptive trial is registered at (NCT05041907). RESULTS: The two 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 qPCRs). Under the linear model, compared with the contemporaneous control arm (no study drug), remdesivir accelerated mean estimated SARS-CoV-2 viral clearance by 42% (95% credible interval [CI] 18 to 73). INTERPRETATION: Parenteral remdesivir accelerates viral clearance in early symptomatic COVID-19. Pharmacometric assessment of therapeutics using the described method can rapidly and efficiently determine in vivo clinical efficacy.

Original publication




Journal article


J Infect Dis

Publication Date



Antiviral efficacy, COVID-19, Pharmacometrics, Remdesivir, SARS-CoV-2