Compassionate Use of Remdesivir for Patients with Severe Covid-19

Autor: Jennifer Cunningham, Marta Mora-Rillo, Robert P. Myers, Gary M. Green, Polly Desai, Toshitaka Maeno, Antonella D’Arminio Monforte, Yoshikazu Mutoh, Emanuele Nicastri, Ilana Henne, Susanna K. Tan, Erika Asperges, Jonathan Grein, Saad Ismail, Alex Studemeister, Rentaro Oda, Anuj Gaggar, Anu Osinusi, Kikuo Yo, Erwan L’Her, Huyen Cao, Hideaki Kato, Duc Nguyen, Seema Ahmed, Daniel Shin, Marco Massari, John Redinski, Giuseppe Lapadula, Lijie Zhong, Shingo Chihara, Laura Telep, Alexander Zoufaly, Daniel Chelliah, Ewa Verweij, Timothy Flanigan, Lucinda Winterbourne, Robertino Mera, Eugenia Quiros-Roldan, Diana M. Brainard, Adam DeZure, Leighann Timbs, Norio Ohmagari, Stuart H. Cohen, Sumit Majumder, Richard Childs, François-Xavier Lescure, Jorge Bernett, Emon Elboudwarej, Yang Zhao, Anand Chokkalingam, Scott Sellers, George Diaz, Torsten Feldt, Margaret L. Green, Danny Chen, Antonella Castagna
Přispěvatelé: Grein, J, Ohmagari, N, Shin, D, Diaz, G, Asperges, E, Castagna, A, Feldt, T, Green, G, Green, M, Lescure, F, Nicastri, E, Oda, R, Yo, K, Quiros-Roldan, E, Studemeister, A, Redinski, J, Ahmed, S, Bernett, J, Chelliah, D, Chen, D, Chihara, S, Cohen, S, Cunningham, J, D'Arminio Monforte, A, Ismail, S, Kato, H, Lapadula, G, L'Her, E, Maeno, T, Majumder, S, Massari, M, Mora-Rillo, M, Mutoh, Y, Nguyen, D, Verweij, E, Zoufaly, A, Osinusi, A, Dezure, A, Zhao, Y, Zhong, L, Chokkalingam, A, Elboudwarej, E, Telep, L, Timbs, L, Henne, I, Sellers, S, Cao, H, Tan, S, Winterbourne, L, Desai, P, Mera, R, Gaggar, A, Myers, R, Brainard, D, Childs, R, Flanigan, T, Grein, J., Ohmagari, N., Shin, D., Diaz, G., Asperges, E., Castagna, A., Feldt, T., Green, G., Green, M. L., Lescure, F. -X., Nicastri, E., Oda, R., Yo, K., Quiros-Roldan, E., Studemeister, A., Redinski, J., Ahmed, S., Bernett, J., Chelliah, D., Chen, D., Chihara, S., Cohen, S. H., Cunningham, J., D'Arminio Monforte, A., Ismail, S., Kato, H., Lapadula, G., L'Her, E., Maeno, T., Majumder, S., Massari, M., Mora-Rillo, M., Mutoh, Y., Nguyen, D., Verweij, E., Zoufaly, A., Osinusi, A. O., Dezure, A., Zhao, Y., Zhong, L., Chokkalingam, A., Elboudwarej, E., Telep, L., Timbs, L., Henne, I., Sellers, S., Cao, H., Tan, S. K., Winterbourne, L., Desai, P., Mera, R., Gaggar, A., Myers, R. P., Brainard, D. M., Childs, R., Flanigan, T.
Rok vydání: 2020
Předmět:
Compassionate Use Trials
Male
viruses
030204 cardiovascular system & hematology
Pharmacology
Medical and Health Sciences
chemistry.chemical_compound
0302 clinical medicine
Japan
80 and over
Medicine
030212 general & internal medicine
Viral
Lung
Polymerase
Aged
80 and over

Alanine
biology
Respiration
General Medicine
Prodrug
Middle Aged
humanities
Europe
Infectious Diseases
6.1 Pharmaceuticals
Artificial
Administration
Original Article
Administration
Intravenous

Female
Intravenous
Coronavirus Infections
Human
Adenosine monophosphate
United State
Adult
Canada
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Clinical Trials and Supportive Activities
Pneumonia
Viral

Administration
Intravenou

Antiviral Agents
03 medical and health sciences
Betacoronavirus
Young Adult
Clinical Research
General & Internal Medicine
Humans
Pandemics
Aged
Antiviral Agent
Betacoronaviru
Pandemic
business.industry
Coronavirus Infection
SARS-CoV-2
Prevention
Compassionate Use
Evaluation of treatments and therapeutic interventions
COVID-19
Pneumonia
Respiration
Artificial

In vitro
Adenosine Monophosphate
United States
COVID-19 Drug Treatment
Coronavirus
Emerging Infectious Diseases
Good Health and Well Being
chemistry
biology.protein
business
Zdroj: New England Journal of Medicine
The New England Journal of Medicine
The New England journal of medicine, vol 382, iss 24
ISSN: 1533-4406
Popis: 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.)
Databáze: OpenAIRE