Phase ? Study to Evaluate the Efficacy and Safety of Regdanvimab for Patients with Mild to Moderate Symptoms of Severe Acute Respiratory Syndrome Coronavirus 2 Infectio
- Conditions
- Codes for special purposes
- Registration Number
- KCT0006254
- Lead Sponsor
- Incheon Medical Center
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
• mild COVID-19 infection diagnosed by RT-PCR.
• no more than 7 days prior to the study drug administration from the onset of symptoms
•Someone who needs supplemental oxygen therapy for SARS-CoV-2 infection.
•According to World Health Organization guidelines, 2020 Any conditions suspected of being severe symptoms of SARS-CoV-2 infection.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method Potential effects on the incidence of antibody-dependent enhancement;Clinical laboratory test(clinical chemistry, hematology, and urinalysis)