COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43251

Dipyaman Ganguly

jaggs.nbmc@gmail.com

2020-05-15

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Patients admitted with RNA PCR proven COVID-19 with <br/ >severe disease (fever or suspected respiratory infection, plus one of the following, respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% at room air) <br/ >with Mild ARDS (200 mmHg < PaO2/FiO2 â?¤ 300 mmHg, with PEEP or CPAP â?¥5 cm H2O, or non-ventilated) <br/ >or Moderate ARDS (100 mmHg < PaO2/FiO2 â?¤200 mmHg, with PEEP â?¥5 cm H2O, or non-ventilated) <br/ >within 5 to 10 days from initial presentation. <br/ >

1. Pregnant mothers <br/ >2. Patients with age less than 18 years <br/ >3. Admitted late after 10 days of initial presentation <br/ >4. Patients refusing consent <br/ >

2

Council of Scientific and Industrial Research

18

80

India

Severe disease at enrollment

6: Severe disease at enrollment

80

2. To compare â??all causeâ?? mortality <br/ >3. To identify the immune correlates for response to plasma therapy. <br/ >Timepoint: 1. Discharge <br/ >2. Discharge/death <br/ >3. Day 0; Day 3; Day 7 after admission

| 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"}]