Compassionate Use of Remdesivir for Patients with Severe Covid-19

Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.

2020-04-10

Grein, Jonathan, Norio Ohmagari, Daniel Shin, George Diaz, Erika Asperges, Antonella Castagna, Torsten Feldt, Gary Green, Margaret L. Green, François-Xavier Lescure, Emanuele Nicastri, Rentaro Oda, Kikuo Yo, Eugenia Quiros-Roldan, Alex Studemeister, John Redinski, Seema Ahmed, Jorge Bernett, Daniel Chelliah, Danny Chen, Shingo Chihara, Stuart H. Cohen, Jennifer Cunningham, Antonella D’Arminio Monforte, Saad Ismail, Hideaki Kato, Giuseppe Lapadula, Erwan L’Her, Toshitaka Maeno, Sumit Majumder, Marco Massari, Marta Mora-Rillo, Yoshikazu Mutoh, Duc Nguyen, Ewa Verweij, Alexander Zoufaly, Anu O. Osinusi, Adam DeZure, Yang Zhao, Lijie Zhong, Anand Chokkalingam, Emon Elboudwarej, Laura Telep, Leighann Timbs, Ilana Henne, Scott Sellers, Huyen Cao, Susanna K. Tan, Lucinda Winterbourne, Polly Desai, Robertino Mera, Anuj Gaggar, Robert P. Myers, Diana M. Brainard, Richard Childs, and Timothy Flanigan. 2020. "Compassionate Use of Remdesivir for Patients with Severe Covid-19." New England Journal of Medicine.

Background

Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.

Methods

We provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day.

Results

Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

Conclusions

In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)

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