To explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
A Multi center, Randomized, Double-blind, Parallel design
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)
Dosage form: 0.9% NaCl solution Frequency: Dose at Day 1, 3, 7
Yeungnam University Medical Center
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Changes from baseline in the clinical improvement score on an 8-point scale at Day 21
Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 21 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Time frame: Day 21
Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28
Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon ranksum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Time frame: Day 7, Day 14, Day 28
Time to discontinuation of oxygen therapy after investigational product administration
The Kaplan-Meier curves for the time to discontinuation of oxygen therapy after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Time frame: Day 28
Time to recovery* after investigational product administration (days)
\*0 to 3 points in the clinical improvement score on an 8-point scale The Kaplan-Meier curves for the time to recovery after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
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Time frame: Day 28
Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28
Descriptive statistics for the changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Time frame: Day 7, Day 14, Day 21, Day 28
Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28
Descriptive statistics for the changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Time frame: Day 7, Day 14, Day 21, Day 28
Mortality at Day 28 and Day 60 after investigational product administration
The frequency and percentage for the proportion of subjects who died at Day 28 and Day 60 after investigational product administration shall be presented for each treatment group, and the Pearson's chi-squared test or the Fisher's exact test shall be performed to test differences of each study group compared to the control group.
Time frame: Day 28, Day 60