Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Hyperimmunoglobulin 50 mg/kg: Participants will receive a dose of50 mg/kg body weight of COVID-19 hyperimmunoglobulin by intravenous route at the rate of not more than 0.5mL/kg/h on Day
Sponsors
Virchow Biotech Private Limited
BIRAC BioIndustry Research Assistant Council
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients �18 and �65 years with active COVID-19 confirmed by RT-PCR, within less than 72 hours prior to randomization; 2.Participants with moderate to severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as: a)Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND b)SpO2 of c)Respiratory rate of �24 per minute 3.Women of childbearing potential agreeing to use of adequate contraception till study completion at a minimum 30 days until after the last dose of study intervention 4.Male participants are eligible if they agree to use contraception /barrier during sexual activities or donation of sperm for the purpose of reproduction PLUS, during the study and till 90 days completion of the study. 5.Participants who are willing to give the consent to particate in the trial.
Exclusion criteria
Exclusion criteria: 1.Participants either with asymptomatic or who are high risk with COVID-19 as per latest (MOHFW guideline) and as per assertion of investigator own decision at screening and at baseline. 2.Participants are not suitable for immunoglobulin therapy and history of known IgA deficiency. 3.Participants with known major illness/organ transplantation/major surgeries during six months before the day of screening. 4.Participants with more than five days of COVID-19 specific hospitalization prior to treatment at baseline 5.Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. 6.Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal and Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. 7.Participation in other studies and have received investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in 8 point ordinal scale in clinical improvement from baseline to day 8Timepoint: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality from baseline to day 28Timepoint: day 28;Change in Oxygenation SpO2/FiO2 ratio from baseline to day 14Timepoint: day 14;Mean change in 8 point ordinal scale in clinical improvement from baseline to day 3 and day 14Timepoint: day 3 and day 14;Proportion of patients negative for SARS-CoV-2 by RT-PCR at Days 3, 8 and 14Timepoint: Days 3, 8 and 14;Time to resolution of following symptoms based on 4-point ordinal scale for 14 days Fever Cough Tiredness Dyspnea Timepoint: 14 days | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed