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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 89% Progression 75% Hospitalization >24hrs or.. 79% primary Gupta et al. NCT04545060 COMET-ICE Sotrovimab RCT EARLY Is early treatment with sotrovimab beneficial for COVID-19? Double-blind RCT 1,057 patients in multiple countries Lower progression (p=0.00041) and death/hosp. (p=0.00039) Gupta et al., JAMA, doi:10.1001/jama.2022.2832 Favors sotrovimab Favors control

Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19

Gupta et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21), COMET-ICE, NCT04545060 (history)
Gupta et al., Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19, JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21), COMET-ICE, NCT04545060
Dec 2021   Source   PDF  
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RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 528 (0.0%), control 2 of 529 (0.4%), NNT 264, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.12, treatment 0 of 528 (0.0%), control 4 of 529 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
risk of progression, 75.0% lower, RR 0.25, p < 0.001, treatment 7 of 528 (1.3%), control 28 of 529 (5.3%), NNT 25, day 29.
risk of hospitalization >24hrs or death, 79.0% lower, RR 0.21, p < 0.001, treatment 6 of 528 (1.1%), control 30 of 529 (5.7%), NNT 22, day 29, ITT, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: research funding from the drug patent holder, employee of the drug patent holder.
Gupta et al., 4 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 68 authors, average treatment delay 2.6 days, trial NCT04545060 (history) (COMET-ICE).
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This PaperSotrovimabAll
Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19
MD Anil Gupta, MD Yaneicy Gonzalez-Rojas, MD Erick Juarez, MD Manuel Crespo Casal, MD Jaynier Moya, MD Diego Rodrigues Falci, PhD Elias Sarkis, MD Joel Solis, MD Hanzhe Zheng, PhD Nicola Scott, MSc Andrea L Cathcart, PhD Sergio Parra, MD, MSc Jennifer E Sager, PhD Daren Austin, PhD Amanda Peppercorn, MD Elizabeth Alexander, MD, MSc Wendy W Yeh, MD Cynthia Brinson, MD Melissa Aldinger, PharmD Adrienne E Shapiro, Almena Free, Kimball Johnson, Edward Cordasco, Raymond Little, Ali Bajwa, Ankur Doshi, Augusto Focil, Rubaba (rubie) Hussain, Greg Bostick, Guillermo Somodevilla, Hasan Ali, John Kowalczyk, Shilpi Mittal, Jorge Caso, Marcy Goisse, Ladynez Espinal, Luis Zepeda, Thinh Nguyen, Luis Martinez, German Alvarez, Ronald Pucillo, Michael Seep, Naval Parikh, Victor Escobar, Armando Curra, Vinicius Dal Maso, John O'mahony, Eduardo Ramacciotti, Jorge Diaz, Kleber Luz, Peter Ruane, Bharat Mochlera, Juan Roldan Sanchez, Luis Hernandez, Alfredo Fernandez, Glenn Leavitt, Masoud Azizad, Haider Afzal, Adil Fatakia, Silvia Narejos Perez, Claudio Marcel Stadnik, Linda Gorgos, Yessica Sachdeva, Patricia Segura, Carlos Quandros, Russell Perry, Lawrence Sher
JAMA, doi:10.1001/jama.2022.2832
IMPORTANCE Older patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression. OBJECTIVE To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.
Conclusions Among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, signifi-cantly reduced the risk of a composite end point of all-cause hospitalization or death through day 29. The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown. Role of the Funder/Sponsor: The sponsors designed the trial and were involved in the conduct of the trial, data collection, management, analysis, and interpretation; participated in the preparation and review of the manuscript; but did not have the right to veto publication. The authors selected the journal and made the decision to submit the manuscript for publication. Group Information: A list of the COMET-ICE Investigators appears in Supplement 3. Data Sharing Statement: See Supplement 4. Additional Contributions: We thank Courtney St Amour, PhD (Cello Health Communications/ SciFluent), for medical writing support, which was funded by Vir Biotechnology Inc and GlaxoSmithKline. We also thank Krystyna Grycz, BA, Jordan Clark, BS, and Minnie Kuo, MS (all 3 employed by Vir Biotechnology Inc), for clinical operations support. These individuals were compensated as part of their normal salaries.
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