Covid-19 Living Data

Trial NCT04679415
Publication Prasenohadi P, J Clin Med (2022) (published paper)
Dates: 2021-01-27 to 2021-07-27
Funding: Private (ImmuneMed Inc., Republic of Korea.)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Indonesia Follow-up duration (days): 28
Inclusion criteria	Adults aged at least 18 years at screening diagnosis of moderate or severe COVID-19 by RT-PCR test within 7 days prior to screening. Patients were identified as moderate if their oxygen saturation (SpO2) was >93%, with respiratory rate (RR) > 20/min or pulse rate (PR) > 90 beats/min secondarily. Severe patients were identified as those with SpO2 < 93% or PaO2/FiO2 < 300, with RR > 30/min or PR > 125 beats/min secondarily. For subjects whose SpO2 was not available at screening because they were already using an oxygen mask, severity was classified according to the investigator’s judgement pneumonia confirmed by radiographic test (CT and/or X-ray) within 5 days prior to the screening visit (e.g., ground glass opacity (GGO), crazy-paving pattern or consolidation) written informed consent prior to any study procedure.
Exclusion criteria	Clinically significant history of hypersensitivity reactions to the components of the study drugs or to other drugs, including NSAIDs or antibiotics, patients with pneumonia resulting from causes other than SARS-CoV-2 infection, as those with severe heart failure (NYHA Class III or higher) pregnant women, and men and women of childbearing potential not agreeing to use clinically appropriate methods of contraception from day 1 until 120 days after the last administration of the test product schedule to organ transplantation ALT or AST ≥ 5 times the upper limit of normal (ULN) eGFR < 30 mL/min/1.73 m2 platelet count < 50,000/mm3 positive for HBV, HCV or HIV and/or those patients vaccinated against COVID-19 within 30 days prior to the screening visit those patients who had been determined to be ineligible to participate in the clinical study according to the investigator’s medical opinion or subjects who planned to be transferred to another hospital within the study period.
Interventions
	Treatment hzVSF-v13 Low dose Initial dose: 200 mg/day intravenously on D1 Maintenance dose: 100 mg/day intravenously on D3 and D7 hzVSF-v13 High dose Initial dose: 400 mg/day intravenously on D1 Maintenance dose: 200 mg/day intravenously on D3 and D7
	Control Placebo
Participants
	Randomized participants : hzVSF-v13 Low dose=22 hzVSF-v13 High dose=23 Placebo=19
	Characteristics of participants N= 64 Mean age : NR 38 males Severity : Mild: n=0 / Moderate: n=33 / Severe: n=29 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 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)
	In the report clinical failure rate at Day 28, defined as death, respiratory failure (patient intubated) or patient in the intensive care unit (ICU)
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the prospective registry (dated December 2020) was available for data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The study (n=64) achieved the target sample size (n=63) specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Safety was reported in the paper, but not listed as an outcome in the registry. Safety was in the title of the study record.