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- Title
Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.
- Authors
Evering, Teresa H.; Chew, Kara W.; Giganti, Mark J.; Moser, Carlee; Pinilla, Mauricio; Wohl, David Alain; Currier, Judith S.; Eron, Joseph J.; Javan, Arzhang Cyrus; Bender Ignacio, Rachel; Margolis, David; Zhu, Qing; Ma, Ji; Zhong, Lijie; Yan, Li; D'Andrea Nores, Ulises; Hoover, Keila; Mocherla, Bharat; Choudhary, Manish C.; Deo, Rinki
- Abstract
This randomized, placebo-controlled trial aimed to determine the overall efficacy and safety of combination therapy with 2 SARS-CoV-2 neutralizing antibodies—amubarvimab and romlusevimab—and evaluated whether there was a benefit of administration more than 5 days after symptom onset. Visual Abstract. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19: This randomized, placebo-controlled trial aimed to determine the overall efficacy and safety of combination therapy with 2 SARS-CoV-2 neutralizing antibodies—amubarvimab and romlusevimab—and evaluated whether there was a benefit of administration more than 5 days after symptom onset. Background: Development of safe and effective SARS-CoV-2 therapeutics is a high priority. Amubarvimab and romlusevimab are noncompeting anti–SARS-CoV-2 monoclonal antibodies with an extended half-life. Objective: To assess the safety and efficacy of amubarvimab plus romlusevimab. Design: Randomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410) Setting: Nonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines. Patients: Adults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression. Intervention: Combination of monoclonal antibodies amubarvimab plus romlusevimab or placebo. Measurements: Nasopharyngeal and anterior nasal swabs for SARS-CoV-2, COVID-19 symptoms, safety, and progression to hospitalization or death. Results: Eight-hundred and seven participants who initiated the study intervention were included in the phase 3 analysis. Median age was 49 years (quartiles, 39 to 58); 51% were female, 18% were Black, and 50% were Hispanic or Latino. Median time from symptom onset at study entry was 6 days (quartiles, 4 to 7). Hospitalizations and/or death occurred in 9 (2.3%) participants in the amubarvimab plus romlusevimab group compared with 44 (10.7%) in the placebo group, with an estimated 79% reduction in events (P < 0.001). This reduction was similar between participants with 5 or less and more than 5 days of symptoms at study entry. Grade 3 or higher treatment-emergent adverse events through day 28 were seen less frequently among participants randomly assigned to amubarvimab plus romlusevimab (7.3%) than placebo (16.1%) (P < 0.001), with no severe infusion reactions or drug-related serious adverse events. Limitation: The study population was mostly unvaccinated against COVID-19 and enrolled before the spread of Omicron variants and subvariants. Conclusion: Amubarvimab plus romlusevimab was safe and significantly reduced the risk for hospitalization and/or death among nonhospitalized adults with mild to moderate SARS-CoV-2 infection at high risk for progression to severe disease. Primary Funding Source: National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
- Subjects
COVID-19; SARS-CoV-2 Omicron variant; SARS-CoV-2; MONOCLONAL antibodies; NEUTRALIZATION tests; COMMUNICABLE diseases
- Publication
Annals of Internal Medicine, 2023, Vol 176, Issue 5, p658
- ISSN
0003-4819
- Publication type
Article
- DOI
10.7326/M22-3428