COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44572

Dr Maya Gopalakrishnan

maya.gopalakrishnan@gmail.com

2020-06-11

Not recruiting

RCT

Randomized

Crossover

Open label

single-center

Treatment

1. >18 years of age <br/ >2. Diagnosed as COVID-19 positive by RT- PCR <br/ >3. Oxygen saturation < 94% as assessed by pulse oximeter or requiring oxygen support <br/ >4. Can communicate and self-prone

1. Any patient requiring immediate intubation and ventilatory care <br/ >2. Hemodynamic instability BP < 90/60 mm Hg or on inotrope support <br/ >3. Elevated intracranial pressure <br/ >4. Altered sensorium or history of seizures <br/ >5. Any psychiatric comorbidity <br/ >6. Massive hemoptysis in the last 48 hours ( >500 ml or requiring transfusion) <br/ >7. Morbid obesity where self-proning is not feasible <br/ >8. Pregnancy <br/ >9. Patients at high risk of requiring CPR or defibrillation (Known arrhythmias)

2

AIIMS Jodhpur

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

120

Primary outcomes (Phase 1 study): <br/ >1. Oxygen saturation measured using by pulse oximeter at 0; 10; 20; 30; 40 minutes <br/ >Primary Outcomes (Phase 2 study): <br/ >1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death <br/ >2. Mortality up to 30 days after enrolmentTimepoint: Primary outcomes (Phase 1 study): <br/ >1. Oxygen saturation measured using by pulse oximeter at 0; 10; 20; 30; 40 minutes <br/ >Primary Outcomes (Phase 2 study): <br/ >1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death <br/ >2. Mortality up to 30 days after enrolment

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "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"}]