COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55876

Dhruva Chaudhry

dhruvachaudhry@yahoo.co.in

2021-05-10

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

COVID19 confirmed case (with nasal or oral swab RT-PCR or rapid antigen positive). <br/ >Chest radiograph suggestive of pneumonia. <br/ >Severity scale according to WHO ordinal scale score of either 4 or 5 or 6 (oxygen requirement or HFNC requirement or NIV requirement or invasive mechanical ventilation). <br/ >Able to and willing to provide informed consent. <br/ >

Patients belonging to category 7 (requiring ECMO or vasopressor support). <br/ >Pregnant subjects. <br/ >Patients participating in other clinical trials. <br/ >Known case of any psychiatric illness. <br/ >Treating physician assessed high likelihood of mortality in 72 hours of randomization. <br/ >Subjects who have received steroids dose of over 0.4 mg/kg/day of dexamethasone or 2mg/kg/day of methylprednisolone for over 2 day in past 14 days. <br/ >Co-existing condition mandating the use of high dose steroids. <br/ >Life threatening comorbidities like <br/ >a. CKD requiring dialysis. <br/ >b. Life threatening new onset arrythmia. <br/ >c. Hypotension. <br/ >d. Evidence or suspicion of active bacterial infection. <br/ >e. Evidence or suspicion of acute onset renal or liver failure <br/ >f. Child C category of chronic liver disease. <br/ >g. Co-existing autoimmune disease requiring immunosuppressive drugs. <br/ >h. Concurrent use of tocilizumab/baricitinib/itolizumab. <br/ >

2

Post Graduate Institute of Medical Sciences PGIMS Rohtak

18

100

India

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

200

Primary efficacy end point will be time to recovery where recovery is defined as fall of 2 points in WHO 8-point ordinal scale or liberation from oxygen therapy.Timepoint: 0; 3rd; 7th; 14th; 28th day

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

Phase 2/Phase 3

[{"arm_notes": "pulse steroid arm", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]