COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49680

Dr Mahendra Kumar Garg

mkgargs@gmail.com

2020-12-07

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Part I: Patients >18 years of age diagnosed as COVID-19 positive by reverse transcriptase Polymerase Chain Reaction (RT PCR) and are having mild COVID-19 with cough or dyspnea or both with room air saturation is within normal limits ( > 94%). <br/ >Part II: Patients >18 years of age diagnosed as COVID-19 positive by reverse transcriptase Polymerase Chain Reaction (RT PCR) and PaO2/FiO2 of 200-350 as assessed by arterial blood gas (ABG) analysis. <br/ >

1.Any patient requiring immediate intubation and ventilatory care <br/ >2.Hemodynamic instability BP < 90/60 mm Hg or on inotropic support <br/ >3.Elevated intracranial pressure <br/ >4.Altered sensorium or history of seizures <br/ >5.Any psychiatric comorbidity <br/ >6.Pregnancy <br/ >7.Patients at high risk of requiring CPR or defibrillation (known arrhythmias) <br/ >8.Known chronic cardiopulmonary diseases like Bronchial asthma (with history of wheeze or bronchodilator use), chronic obstructive pulmonary disease, interstitial lung disease (aassessed by Computed Tomography (CT) Chest), congestive heart failure (clinical assessment), and obstructive sleep apnea (assessed with Epworth Sleepiness scale). <br/ >9.Any recent acute condition like pulmonary embolism, acute coronary syndrome, deep vein thrombosis, intestinal obstruction or cerebrovascular accident. <br/ >

2

All India Institute of Medical Sciences Jodhpur

18

100

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

Primary outcome â?? I: Time to becoming symptom free (cough; breathlessness. <br/ >Primary outcome â?? II: Change in PaO2/FiO2 ratio in both groups will be compared. <br/ >Timepoint: Primary outcome â?? I: Time to becoming symptom free (cough; breathlessness; assessed at 6th day. <br/ >Primary outcome â?? II: Change in PaO2/FiO2 ratio in both groups will be compared at end of 6th day. <br/ >

Phase 2

[{"arm_notes": "", "treatment_id": 430, "treatment_name": "Early liberal oxygen therapy", "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"}]