COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62937

Dr Vijaykumar H N

Vijay.bmc.ccm@gmail.com

2021-11-29

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Age 18-75 yrs <br/ > 2. Adult patients with RTPCR confirmed. <br/ > 3. Patients with CT Scan features ( CORAD score4 and above) <br/ > 4. Patients with severe COVID 19 infection whose room air saturation is <93% .

1. Patients with multi organ failure , Shock , DIC . <br/ > 2. Patients with complicated COVID 19 infection . <br/ > 3. Respiratory failure due to other causes such as head injury , CNS infection , DKA, severe electrolyte disturbances, neuromuscular diseases . <br/ > 4. Past history of COPD , bronchial asthma . <br/ > 5. Patients with cardiac disease . <br/ > 6 . Patients with chronic kidney disease on hemodialysis .

2

Government medical college

18

85

India

Severe disease at enrollment

6: Severe disease at enrollment

291

Mortality at day 14 and 28 <br/ >No.of patients requiring invasive ventilation <br/ >No. Of icu days and hospital <br/ >Incidence of secondary infectionTimepoint: Mortality at day 14 and 28 <br/ >No.of patients requiring invasive ventilation <br/ >No. Of icu days and hospital <br/ >Incidence of secondary infection

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

Phase 4

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]