iberal use of oxygen in early stage of COVID-19 patients.

Phase 2

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/12/029614

Lead Sponsor: All India Institute of Medical Sciences Jodhpur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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%).

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.

Exclusion Criteria

1.Any patient requiring immediate intubation and ventilatory care

2.Hemodynamic instability BP < 90/60 mm Hg or on inotropic support

3.Elevated intracranial pressure

4.Altered sensorium or history of seizures

5.Any psychiatric comorbidity

6.Pregnancy

7.Patients at high risk of requiring CPR or defibrillation (known arrhythmias)

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).

9.Any recent acute condition like pulmonary embolism, acute coronary syndrome, deep vein thrombosis, intestinal obstruction or cerebrovascular accident.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The following if occurring during the study duration are considered as outcomes/events and the patient will be followed up but trial will be ended for that patient if <br/ ><br>1.Intubation/Mechanical Ventilation or Non-invasive ventilation. <br/ ><br>2.Fall of PaO2/FiO2 to less than 200 with oxygen supplementation or rises to more than 350 without oxygen supplementation. <br/ ><br>3.Death of any patient in study duration <br/ ><br>4.Patient undergoing off oxygen trial and successfully completing it. <br/ ><br>Timepoint: day 6