Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe 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 SARS-CoV-2 infection, were hospitalized, had oxygen saturation 94% or lower 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 2.03: 95% confidence interval 1.34-3.08, p
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.
Olender, Susan A; Perez, Katherine K; Go, Alan S; Balani, Bindu; Price-Haywood, Eboni G; Shah, Nirav S; Wang, Su; Walunas, Theresa L; Swaminathan, Shobha; Slim, Jihad; Chin, BumSik; De Wit, Stéphane; Ali, Shamim M; Soriano Viladomiu, Alex; Robinson, Philip A; Gottlieb, Robert L; Tsang, Tak Yin Owen; Lee, I-Heng; Haubrich, Richard H; Chokkalingam, Anand P; Lin, Lanjia; Zhong, Lijie; Bekele, B Nebiyou; Mera-Giler, Robertino; Gallant, Joel; Smith, Lindsey E; Osinusi, Anu O; Brainard, Diana M; Hu, Hao; Phulpin, Chloé; Edgar, Holly; Diaz-Cuervo, Helena; and Bernardino, Jose I, "Remdesivir for Severe COVID-19 versus a Cohort Receiving Standard of Care." (2020). Articles, Abstracts, and Reports. 3579.