An Open-Label, Randomized, Controlled, Multicenter Study to evaluate the Efficacy and Safety of COVID-19 Hyperimmunoglobulin in Patients with COVID-19

Virchow Biotech Private Limited0 个研究点目标入组 66 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Male and female patients Ã¢â?°Â¥18 and Ã¢â?°Â¤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 <93 % on room air AND
•c)Respiratory rate of Ã¢â?°Â¥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.

•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.

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