COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43149

Dr Anup Agarwal

mailanupagarwal@gmail.com

2020-04-21

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ >2. Age > 18 years <br/ >3. Has any of the two <br/ >a. PaO2/ FiO2: 200-300 <br/ >b. Respiratory Rate > 24/min and SaO2 < 93% on room air <br/ >4. Availability of matched donor plasma at the point of enrolment <br/ >

1. Pregnant women <br/ >2. Breastfeeding women <br/ >3. Known hypersensitivity to blood products <br/ >4. Receipt of pooled immunoglobulin in last 30 days <br/ >5. Critically ill patients: <br/ >a. P/F ratio <200 (moderate - severe ARDS) <br/ >b. Shock <br/ >6. Participating in any other clinical trial <br/ >7. Clinical status precluding infusion of blood products <br/ >

2

Indian Council Of Medical Research

18

90

India

Severe disease at enrollment

6: Severe disease at enrollment

452

The primary outcome is a composite measure of the avoidance of - <br/ >1. Progression to severe ARDS (P/F ratio 100) or <br/ >2. All-cause Mortality at 28 days <br/ >Timepoint: 28 days from intervention <br/ >

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]