As COVID-19 evolves, the development of safe and effective therapeutics is a high priority. Amubarvimab and romlusevimab are non-competing anti-SARS-CoV-2 monoclonal antibodies with an extended half-life that may be an effective and safe option for persons who are at high risk of clinical progression to severe COVID-19.
A randomized controlled trial of more than 800 adults diagnosed with COVID-19 found that combination therapy with amubarvimab plus romlusevimab significantly reduced the rates of hospitalization and death compared to placebo. The clinical benefit was similar regardless of whether therapy was given within 5 days or more than 5 days of symptom onset. The findings are published in Annals of Internal Medicine.
ACTIV-2/A5401 is a multinational, adaptive platform treatment trial designed to evaluate the safety and efficacy of investigational agents for the treatment of nonhospitalized adults with COVID-19. In the study of amubarvimab and romlusevimab, researchers randomly assigned 807 persons with symptomatic COVID-19 infection who were at high risk of clinical progression to be treated with either amubarvimab plus romlusevimab or placebo to assess the regimen’s safety and efficacy. Half of all participants received combination therapy with amubarvimab plus romlusevimab and the other half received placebo. The authors observed a 79 percent reduction in progression to hospitalization and death for persons receiving the active therapy. They also found that hospitalization and death occurred in only 2.3 percent of participants who received amubarvimab plus romlusevimab compared to 10.7 percent of participants who received placebo. Adverse events were observed in 7.3 percent of persons receiving amubarvimab plus romlusevimab compared with 16.1 percent of persons receiving placebo. However, the authors advise that these medications’ utility is likely to be limited for currently circulating COVID-19 subvariants.
Teresa H. Evering, Kara W. Chew, Mark J. Giganti, et al; ACTIV-2/A5401 Study Team. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19. Ann Intern Med. [Epub 18 April 2023]. doi:10.7326/M22-3428