Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.

Autor:	Olender SA; Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA., Perez KK; Houston Methodist, Houston, Texas, USA., Go AS; Division of Research, Kaiser Permanente Northern California, Oakland, California, USA., Balani B; Hackensack University Medical Center, Hackensack, New Jersey, USA., Price-Haywood EG; Ochsner Health System and Ochsner Clinical School, New Orleans, Louisiana, USA., Shah NS; NorthShore University Health System, Evanston, Illinois, USA., Wang S; Saint Barnabas Medical Center, RWJBarnabas Medical Group, Livingston, New Jersey, USA., Walunas TL; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Swaminathan S; Rutgers New Jersey Medical School, Newark, New Jersey, USA., Slim J; Prime Healthcare Services, St Michael's LLC, Newark, New Jersey, USA., Chin B; National Medical Center, Seoul, South Korea., De Wit S; NEAT ID Foundation, CHU Saint Pierre, Brussels, Belgium., Ali SM; NEAT ID Foundation, Chelsea and Westminster Hospital, London, United Kingdom.; School of Medicine, Moi University, Eldoret, Kenya., Soriano Viladomiu A; Hospital Clinic de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain., Robinson P; Hoag Memorial Hospital Presbyterian, Newport Beach, California, USA., Gottlieb RL; Baylor University Medical Center Dallas, Dallas, Texas, USA.; Baylor Scott and White Health, Dallas, Texas, USA., Tsang TYO; Princess Margaret Hospital, Kwai Chung, Hong Kong., Lee IH; Gilead Sciences, Foster City, California, USA., Hu H; Gilead Sciences, Causeway Bay, Hong Kong., Haubrich RH; Gilead Sciences, Foster City, California, USA., Chokkalingam AP; Gilead Sciences, Foster City, California, USA., Lin L; Gilead Sciences, Foster City, California, USA., Zhong L; Gilead Sciences, Foster City, California, USA., Bekele BN; Gilead Sciences, Foster City, California, USA., Mera-Giler R; Gilead Sciences, Foster City, California, USA., Phulpin C; Gilead Sciences, Stockley Park, Uxbridge, United Kingdom., Edgar H; Gilead Sciences, Stockley Park, Uxbridge, United Kingdom., Gallant J; Gilead Sciences, Foster City, California, USA., Diaz-Cuervo H; Gilead Sciences, Madrid, Spain., Smith LE; Gilead Sciences, Foster City, California, USA., Osinusi AO; Gilead Sciences, Foster City, California, USA., Brainard DM; Gilead Sciences, Foster City, California, USA., Bernardino JI; Hospital La Paz, IdiPAZ, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Dec 06; Vol. 73 (11), pp. e4166-e4174.
DOI:	10.1093/cid/ciaa1041
Abstrakt:	Background: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. Methods: GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results: After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34-3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22-.68, P = .001). Conclusions: In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. Clinical Trials Registration: NCT04292899 and EUPAS34303. (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)
Databáze:	MEDLINE
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