COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50900

Dr Hemanth Nandigala

hnandigala@gmail.com

2021-01-29

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1.Male and female patients â?¥18 and â?¤65 years with active COVID-19 confirmed by RT-PCR, within less than 72 hours prior to randomization, <br/ >2.Participants with moderate to severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as: <br/ >a)Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ >b)SpO2 of <93 % on room air AND <br/ >c)Respiratory rate of â?¥24 per minute <br/ >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 <br/ >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. <br/ >5.Participants who are willing to give the consent to particate in the trial. <br/ >

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. <br/ >2.Participants are not suitable for immunoglobulin therapy and history of known IgA deficiency. <br/ >3.Participants with known major illness/organ transplantation/major surgeries during six months before the day of screening. <br/ >4.Participants with more than five days of COVID-19 specific hospitalization prior to treatment at baseline <br/ >5.Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ >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. <br/ >7.Participation in other studies and have received investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ >

3

Virchow Biotech Private Limited

18

65

India

Severe disease at enrollment

6: Severe disease at enrollment

66

Mean change in 8 point ordinal scale in clinical improvement from baseline to day 8Timepoint: Day 8

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "50 mg/kg", "treatment_id": 89, "treatment_name": "Anti-covid-19 hyperimmune globulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "75 mg/kg", "treatment_id": 89, "treatment_name": "Anti-covid-19 hyperimmune globulin", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]