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. 2020 Jun 11;382(24):2327-2336.
doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.

Compassionate Use of Remdesivir for Patients with Severe Covid-19

Jonathan Grein  1 , Norio Ohmagari  1 , Daniel Shin  1 , George Diaz  1 , Erika Asperges  1 , Antonella Castagna  1 , Torsten Feldt  1 , Gary Green  1 , Margaret L Green  1 , François-Xavier Lescure  1 , Emanuele Nicastri  1 , Rentaro Oda  1 , Kikuo Yo  1 , Eugenia Quiros-Roldan  1 , Alex Studemeister  1 , John Redinski  1 , Seema Ahmed  1 , Jorge Bernett  1 , Daniel Chelliah  1 , Danny Chen  1 , Shingo Chihara  1 , Stuart H Cohen  1 , Jennifer Cunningham  1 , Antonella D'Arminio Monforte  1 , Saad Ismail  1 , Hideaki Kato  1 , Giuseppe Lapadula  1 , Erwan L'Her  1 , Toshitaka Maeno  1 , Sumit Majumder  1 , Marco Massari  1 , Marta Mora-Rillo  1 , Yoshikazu Mutoh  1 , Duc Nguyen  1 , Ewa Verweij  1 , Alexander Zoufaly  1 , Anu O Osinusi  1 , Adam DeZure  1 , Yang Zhao  1 , Lijie Zhong  1 , Anand Chokkalingam  1 , Emon Elboudwarej  1 , Laura Telep  1 , Leighann Timbs  1 , Ilana Henne  1 , Scott Sellers  1 , Huyen Cao  1 , Susanna K Tan  1 , Lucinda Winterbourne  1 , Polly Desai  1 , Robertino Mera  1 , Anuj Gaggar  1 , Robert P Myers  1 , Diana M Brainard  1 , Richard Childs  1 , Timothy Flanigan  1
Affiliations

Compassionate Use of Remdesivir for Patients with Severe Covid-19

Jonathan Grein et al. N Engl J Med. .

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.).

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Figures

Figure 1
Figure 1. Oxygen-Support Status at Baseline and after Treatment.
For each oxygen-support category, percentages were calculated with the number of patients at baseline as the denominator. Improvement (blue cells), no change (beige) and worsening (gray) in oxygen-support status are shown. Invasive ventilation includes invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or both. Noninvasive ventilation includes nasal high-flow oxygen therapy, noninvasive positive pressure ventilation (NIPPV), or both.
Figure 2
Figure 2. Changes in Oxygen-Support Status from Baseline in Individual Patients.
Baseline (day 0) was the day on which treatment with remdesivir (RDV) was initiated. Final oxygen support statuses shown are based on the most recent reported data. For each patient, the colors in the line represent the oxygen-support status of the patient over time. The colored circles to the left of each line indicate the patient’s overall change in status from baseline. A patient’s status “improved” if the oxygen-support status improved before the last follow-up or the patient was discharged. The vertical black marks show the last day of treatment with RDV. The gray dashed lines represent missing data between the patient’s most recent reported oxygen status and an event (death or discharge) or the last dose of RDV. A solid square at the end of a line indicates that the patient died; an open diamond indicates that the patient was discharged from the hospital. If there is neither a square nor a diamond at the end of a line, neither death nor discharge had occurred. Patient 2 was breathing ambient air through day 36. Patients 19 and 31 were discharged on day 44.
Figure 3
Figure 3. Cumulative Incidence of Clinical Improvement from Baseline to Day 36.
Clinical improvement is shown in the full cohort, in the cohort stratified according to ventilation status at baseline, and in the cohort stratified by age.
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