COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47524

Dr John Paul M

drjohnpaulm@gmail.com

2020-10-19

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Male and female above 18 years till 65 years with moderate COVID Disease

Patients with pre-existing kidney and liver diseases. <br/ >Pregnant and lactating women <br/ >Patients with hyperreactive airway disease and obstructive airway disease. <br/ >Patients with co-infections. <br/ >Immunocompromised patients, either by disease condition(HIV-AIDS..etc) or by drugs( immunomodulators..etc) <br/ >Patients who are declining to give consent <br/ >

2

Sparsh Foundation

18

65

India

Moderate disease at enrollment

3: Moderate disease at enrollment

40

1) Mortality <br/ >2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ >3) Change in markers of inflammation.- IL-6;CRP;Ferritin; D-dimer AND LDHTimepoint: 1) Mortality at 28 days <br/ >2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ >3) Change in markers of inflammation.- IL-6;CRP;Ferritin; D-dimer AND LDH on Day 4 Day 7 and Day 10.

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

Not reported

[{"arm_notes": "", "treatment_id": 443, "treatment_name": "Edaravone", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]