Abstract
Introduction: Treatments for subjects with Covid-19 are required. One approach is neutralizing monoclonal antibodies. Bamlanivimab and etesevimab are monoclonal antibodies to SARS-CoV-2.
Areas covered: This evaluation is of the phase 3 BLAZE-1 clinical trial, which was of bamlanivimab plus etesevimab in adult ambulatory participants with a risk factor for, and mild to moderate, Covid-19 illness. The primary outcome was Covid 19 related hospitalization of ≥ 24 hours or death from any cause by day 29, and this occurred in 2.1% subjects in the bamlanivimab/etesevimab group, compared to 7.0% in the placebo group.
Expert opinion: In the pandemic, the attempts by the FDA to shorten approval processes for medicines and by journals to make information available in a timely manner are admirable. However, these shortened processes made negotiating the details of BLAZE-1 and producing accurate and critical appraisals difficult. It seems to me that if there are any benefits of bamlanivimab alone in Covid-19, they are not clear-cut. Bamlanivimab has limited effects against the beta and gamma variants and is not effective against the delta variant. Thus, the benefits of bamlanivimab/etesevimab in the phase 3 of the BLAZE-1 may be solely due to etesevimab, and this needs to be tested.
Keywords: BLAZE-1; Bamlanivimab; Covid-19; etesevimab; phase 3 clinical trial.
【저자키워드】 COVID-19, bamlanivimab, etesevimab, BLAZE-1, phase 3 clinical trial., 【초록키워드】 SARS-CoV-2, clinical trial, pandemic, Hospitalization, monoclonal antibody, variant, risk factor, delta variant, monoclonal antibodies, FDA, bamlanivimab, Medicine, etesevimab, death, Mild, Beta, critical appraisal, information, moderate, neutralizing monoclonal antibodies, Phase 3, mild to moderate, 24 hours, not effective, Medicines, Primary outcome, placebo group, subject, COVID-19 illness, approval, participant, Effect, approach, expert, effective, benefit, tested, occurred, required, producing, Area, 24 hour, the placebo group,