COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48879

Dr Alben Sigamani

vimal.bhardwaj.dr@narayanahealth.org

2020-11-16

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Patient may be diagnosed with COVID-19 pneumonia based on clinical history consistent with COVID 19 without PCR proof <br/ >2.Acute lung injury as evidenced by P/F ratio <300 <br/ >3. Clinician deems failure of therapy with conventional low flow oxygen

1.Need for direct admission to the intensive care unit for invasive ventilation <br/ >2.Unconscious or patient with drowsiness. <br/ >3. Pneumothorax.

2

JFD Limited

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

240

The co-primary efficacy outcome for this trial is a <br/ >composite of invasive ventilation or death at 30 days after randomization. <br/ >The co-primary safety outcome for this trial is any incident cases of hypopnea that results from a failure of the device at 30 days after randomizationTimepoint: 30 days after randomization

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

Not reported

[{"arm_notes": "", "treatment_id": 904, "treatment_name": "Non invasive ventilation", "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"}]