Phase ? Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

A total of 19 subjects were reported, and 17 (89.5%) participated in this study. The two subjects (10.5%) are focused on the wrong direction for spring and autumn observations. The age range of test subjects was 29 to 82 years, and the proportion of male subjects (11 subjects [57.9%]) was higher than that of female subjects (8 subjects [42.1%]). The severity of COVID-19 virus (SARS-CoV-2) infection of the test subjects at the time of enrollment in the study was mild 7 cases (36.8%) and moderate severity 12 cases (63.2%). Safety was confirmed after a single intravenous (IV) administration of regdanvimab 40 mg/kg in patients with mild and moderate COVID-19 virus (SARS-CoV-2) infection. Overall, a total of 6 adverse events were reported in 4 subjects (21.1%). The severity of all adverse events was CTCAE Grade 1 or Grade 2, and no causal relationship with investigational drugs was reported. No serious adverse events or dropouts due to adverse events were reported. As a result of analysis of the concentration of COVID-19 virus (SARS-CoV-2) in quantitative reverse transcription polymerization chain reaction (RT-qPCR) test, 4 (21.1%) test subjects were converted to negative on the 14th day. This was compared to an average of 22.5 days for natural COVID-19 virus (SARS-CoV-2) negative conversion (Carmo A et al., 2020). means that 15 patients (78.9%) recovered clinically by day 28, and the median recovery time was 7.0 days. By the 28th day, 3 subjects (15.8%) required supplemental oxygen supply due to COVID-19 virus (SARS-CoV-2) infection. There was no single test subject