VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Summary
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.
Timeline
- Start
- 2020-08-27
- Primary completion
- 2021-04-08
- Completion
- 2021-09-02
Outcome
Met primary endpoint
registry Sotrovimab (500 mg IV) vs Placebo; p <0.001; adjusted relative risk ratio 0.21 (95% CI 0.09 to 0.50) NCT04545060 ↗
paper All-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) PMID 35285853 ↗
release “COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo” vir.bio ↗
release “an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial.” vir.bio ↗
release “demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial” vir.bio ↗
release “85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial” vir.bio ↗
release “The primary efficacy analysis of all 1,057 patients in the COMET-ICE trial demonstrated a 79% reduction” vir.bio ↗
release “meeting the primary endpoint of the trial.” vir.bio ↗
release “The primary efficacy analysis of all 1,057 patients in the COMET-ICE trial demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001)” gsk.com ↗
release “meeting the primary endpoint of the trial” gsk.com ↗
Publications
- Results Maher MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A. Antibody therapy reverses biological signatures of COVID-19 progression. Cell Rep Med. 2022 Aug 16;3(8):100721. doi: 10.1016/j.xcrm.2022.100721.
- Results Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1236-1246. doi: 10.1001/jama.2022.2832.
- Results Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
- Subramanian S, Schnell G, Iulio JD, Gupta AK, Shapiro AE, Sarkis EH, Lopuski A, Peppercorn A, Aldinger M, Hebner CM, Cathcart AL. Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study. Future Virol. 2023 Nov:10.2217/fvl-2023-0146. doi: 10.2217/fvl-2023-0146. Epub 2023 Dec 7.
- Satram S, Ghafoori P, Reyes CM, Keeley TJH, Birch HJ, Brintziki D, Aldinger M, Alexander E, Lopuski A, Sarkis EH, Gupta A, Shapiro AE, Powers JH 3rd. Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19. J Patient Rep Outcomes. 2023 Sep 13;7(1):92. doi: 10.1186/s41687-023-00621-8.
- Keeley TJH, Satram S, Ghafoori P, Reyes C, Birch HJ, Raymond K, Gelhorn HL, Kosinski M, Saucier CD, Mitchell Foster A, Lopuski A, Powers JH 3rd. Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus(c)) instrument in patients with COVID-19. Qual Life Res. 2023 Jun;32(6):1645-1657. doi: 10.1007/s11136-022-03336-3. Epub 2023 Jan 27.
- Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotrovimab | Monoclonal antibody | 500 mg | Intravenous |