COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44539

Dalim Kumar Baidya

dalimkumar.ab8@gmail.com

2020-07-27

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

One hundred adult patients (aged between 18 and 75y) with laboratory confirmed diagnosis of COVID-19 pneumonia, presenting with severe COVID-19 pneumonia, who fail oxygen therapy by facemask, will be included in this study after ethics committee approval and informed written consent from the patients or their legally acceptable representatives.

Following patients will be excluded <br/ >i) refusal to participate, <br/ >ii) hemodynamically unstable patients on high dose vasopressor therapy <br/ >iii) pregnant patients <br/ >iv) COPD / chronic respiratory failure <br/ >v) Morbid obesity <br/ >vi) Patients with urgent requirement of invasive mechanical ventilation <br/ >

2

All India Institute of Medical Sciences New Delhi

18

75

India

Severe disease at enrollment

6: Severe disease at enrollment

100

Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admissionTimepoint: Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission

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

Phase 3/Phase 4

[{"arm_notes": "", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]