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

Abstract

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.).

• Authors: Jonathan Grein, 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, Timothy Flanigan
• Journal: The New England journal of medicine (N Engl J Med) Vol. 382 Issue 24 Pg. 2327-2336 (06 11 2020) ISSN: 1533-4406 [Electronic] United States
• PMID: 32275812 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Massachusetts Medical Society.

Chemical References

• Antiviral Agents
• remdesivir
• Adenosine Monophosphate
• Alanine

Topics

• Adenosine Monophosphate (adverse effects, analogs & derivatives, therapeutic use)
• Administration, Intravenous
• Adult
• Aged
• Aged, 80 and over
• Alanine (adverse effects, analogs & derivatives, therapeutic use)
• Antiviral Agents (adverse effects, therapeutic use)
• Betacoronavirus
• COVID-19
• Canada
• Compassionate Use Trials
• Coronavirus Infections (drug therapy, mortality)
• Europe
• Female
• Humans
• Japan
• Male
• Middle Aged
• Pandemics
• Pneumonia, Viral (drug therapy, mortality)
• Respiration, Artificial
• SARS-CoV-2
• United States
• Young Adult
• COVID-19 Drug Treatment