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.
References
Cameroni, Bowen, Rosen, Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift, Nature. Published online,
doi:10.1038/s41586-021-04386-2Chen, Nirula, Heller, None
Craft, Travassos, Palacios, Openshaw, Inadequate minority representation within SARS-CoV-2 vaccine trials, Am J Trop Med Hyg,
doi:10.4269/ajtmh.20-1294Fajnzylber, Regan, Coxen, Massachusetts Consortium for Pathogen Readiness. SARS-CoV-2 viral load is associated with increased disease severity and mortality, Nat Commun,
doi:10.1038/s41467-020-19057-5Focosi, Maggi, Neutralising antibody escape of SARS-CoV-2 spike protein: risk assessment for antibody-based Covid-19 therapeutics and vaccines, Rev Med Virol,
doi:10.1002/rmv.2231Gao, Ding, Dong, Risk factors for severe and critically ill COVID-19 patients: a review, Allergy,
doi:10.1111/all.14657Gaudinski, Coates, Houser, Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: a phase 1 open-label clinical trial in healthy adults, PLoS Med,
doi:10.1371/journal.pmed.1002493Gupta, Gonzalez-Rojas, Juarez, Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab, N Engl J Med,
doi:10.1056/NEJMoa2107934Han, Poon, Powers, Iii, Leidy et al., Using the Influenza Patient-Reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model, BMC Infect Dis,
doi:10.1186/s12879-018-3220-8Hwang, Shih, Cani, Arvin, Fink et al., Group sequential designs using a family of type I error probability spending functions, Stat Med,
doi:10.1038/s41586-020-2538-8Investigators, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med,
doi:10.1056/NEJMoa2029849Lan, Demets, Discrete sequential boundaries for clinical trials, Biometrika,
doi:10.2307/2336502Levey, Bosch, Lewis, Greene, Rogers et al., Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate from serum creatinine: Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19 Original Investigation Research jama.com, Ann Intern Med,
doi:10.7326/0003-4819-130-6-199903160-00002Lustig, Zuckerman, Nemet, Neutralising capacity against Delta (B.1.617.2) and other variants of concern following Comirnaty (BNT162b2, BioNTech/Pfizer) vaccination in health care workers, Israel, Euro Surveill,
doi:10.2807/1560-7917.ES.2021.26.26.2100557Seyedalinaghi, Afsahi, Mohssenipour, Late complications of COVID-19; a systematic review of current evidence, Arch Acad Emerg Med
Starr, Greaney, Dingens, Bloom, Complete map of SARS-CoV-2 RBD mutations that escape the monoclonal antibody LY-CoV555 and its cocktail with LY-CoV016, Cell Rep Med,
doi:10.1016/j.xcrm.2021.100255Stokes, Zambrano, Anderson, Coronavirus disease 2019 case surveillance-United States, MMWR Morb Mortal Wkly Rep,
doi:10.15585/mmwr.mm6924e2Vanblargan, Errico, Halfmann, An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies, Nat Med. Published online,
doi:10.1038/s41591-021-01678-yWiersinga, Rhodes, Cheng, Peacock, Prescott, Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review, JAMA,
doi:10.1001/jama.2020.12839?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jama.2022.2832Zheng, Yu, Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study, BMJ,
doi:10.1136/bmj.m1443DOI record:
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