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
Multi center, Randomized, Double-blind, Parallel group, Phase 2 clinical study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Dosage form: hzVSF-v13 40 mg/mL in a 5 mL vial Frequency: Dose at Day 1, 3, 7
Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7
Rumah Sakit Pusat Pertamina (include RSPP Extension Simprug)
Jakarta, Jakarta Special Capital Region, Indonesia
Rumah Sakit Pasar Minggu
Jakarta, Jakarta Special Capital Region, Indonesia
Rumah Sakit Umum Persahabatan
Jakarta, Jakarta Special Capital Region, Indonesia
Clinical failure rate at Day 28
The clinical failure rate is defined at Day 28 if patient reported any of * Death * Respiratory failure (patient is intubated) * Patient is in the Intensive Care Unit (ICU)
Time frame: Day 28
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.
Time frame: Day 28
Time to Clinical Improvement from randomization to clinical improvement (2 points decreased from the baseline score) (days)
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The Kaplan-Meier curves for the time to Clinical Improvement after randomization 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
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, and 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