Compassionate Use of Remdesivir for Patients with Severe Covid-19.

Jonathan Grein
Norio Ohmagari
Daniel Shin
George Diaz, Providence Regional Medical Center
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
Timothy Flanigan


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.).