Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Summary

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Timeline

Start

2020-03-06

Primary completion

2020-04-09

Completion

2020-06-30

Outcome

Missed primary endpoint

registry p = 0.1563; Odds Ratio (OR) 0.75 (95% CI 0.507 to 1.115) NCT04292899 ↗

Publications

• Background Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.
• Fusco D, Malenica I, Gunthard HF, Gupta SK, Kurbegov D, Balani B, Olender S, Aberg JA, Telep LE, Tian Y, Blair C, Wu G, Haubrich RH, Wang CY, Chokkalingam AP, Osinusi AO, Wendtner CM, Gottlieb RL. Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies. Clin Infect Dis. 2024 Nov 22;79(5):1182-1189. doi: 10.1093/cid/ciae336.
• Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
• Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

Drugs

Indications