![]() ![]() placebo) was also more than 1 for those with plasma antigen or nasal viral RNA levels above median level at entry and was greatest for those without antibodies and with elevated levels of antigen (sHR, 1.48 ) or viral RNA (sHR, 1.89 ). Among those without and with nAbs at study entry, the sHRs were 1.24 (CI, 0.90 to 1.70) and 0.74 (CI, 0.54 to 1.00), respectively (nominal P for interaction = 0.018). At entry, 50% evidenced production of anti-spike nAbs 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1000 ng/L. Patients were followed for 90 days for sustained recovery (defined as discharge to home and remaining home for 14 consecutive days) and a composite safety outcome (death, serious adverse events, organ failure, or serious infections).Īmong 314 participants (163 receiving bamlanivimab and 151 placebo), the median time to sustained recovery was 19 days and did not differ between the bamlanivimab and placebo groups (subhazard ratio, 0.99 sHR > 1 favors bamlanivimab). Hospitalized patients with COVID-19 without end-organ failure.Īntibody, antigen, and viral RNA levels were centrally measured on stored specimens collected at baseline. To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high. ![]() In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment. ACTIV-3/TICO Bamlanivimab Study Group Jens D Lundgren
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