COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44604

Professor Vivekanand Jha

vjha@georgeinstitute.org.in

2021-04-27

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Age â?¥ 18 years <br/ >2. Laboratory confirmed COVID-19 positive infection <br/ >3. Requiring more than 40% oxygen (FiO2 > 0.4) â?? (requiring 6L or more of oxygen by Hudson mask <br/ >or nasal cannula) to maintain SpO2 >93%

1. Obtunded <br/ >2. The attending clinician is not committed to patient receiving mechanical ventilatory support <br/ >3. In the opinion of the treating clinician the patient is in respiratory distress and is eminently <br/ >requiring escalation of treatment including intubation and mechanical ventilation <br/ >4. Currently receiving either CPAP, BiPAP, high flow nasal prongs or mechanical ventilation <br/ >5. Participants usually on home ventilation (either CPAP or BiPAP) <br/ >6. Previous participation in PROVE trial <br/ >7. Known or suspected pregnancy <br/ >8. Enrolment in the study is not in the best interest of the patient as deemed by the treating clinician

2

George Institute for Global Health India

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

1800

Need for escalation of respiratory support; defined as; need for CPAP; BIPAP; or <br/ >invasive mechanical ventilationTimepoint: Upto 14 days following randomization

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

Phase 3

[{"arm_notes": "", "treatment_id": 770, "treatment_name": "Materialise passive non-invasive peep device mask", "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"}]