Ozone Therapy for Covid 19 patients

Not Applicable

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

Registration Number: CTRI/2020/07/026671

Lead Sponsor: Bisleri charitable trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients confirmed to be COVID-19 positive by quantitative real time polymerase chain reaction (QRT-PCR) assay

2. Patients that meet any one of the criteria of moderate stage

3. Patients who give written informed consent.

4. Age 18 â?? 65 years

Exclusion Criteria

1. Mild or severe stage

2. G6PD deficiency

3. Hyperthyroidism

4. Bleeding disorders (any coagulopathies)

5. Chronic uncontrolled illnesses such as uncontrolled diabetes, uncontrolled hypertension chronic renal failure, chronic liver disease, chronic neurodegenerative disorders, chronic heart conditions (chronic heart failure, chronic angina, previous

myocardial infarction), malignancies, etc.,

6. Pregnant and lactating women

7. Patients on immunosuppressant drugs

8. Patients with a history of organ transplantation

9. Patients who are participating in other clinical trials

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a. Time to recovery on 8 point ordinal scale (Time to reach point 6-8) <br/ ><br>b. Time to Resolution of symptoms (Fever, cough, respiratory rate, shortness of <br/ ><br>breath) <br/ ><br>c. PAO2/FiO2 <br/ ><br>d. Chest X-ray â?? Day 1, 7 & 14 <br/ ><br>e. Inflammatory Biomarkers: <br/ ><br>C- reactive Protein,IL-6,Ferritin,LDH, D-Dimer <br/ ><br>e. Percentage of patients declining to serious stage at the end of 14 days <br/ ><br>f. Percentage of patients improving to mild stage at the end of 14 daysTimepoint: Day 1 <br/ ><br>Day 3 <br/ ><br>Day 6 <br/ ><br>Day 10 <br/ ><br>Day 14

Secondary Outcome Measures

Name	Time	Method
a. Oxygen saturation index: SPO2 / FiO2 <br/ ><br>b. Total blood count: WBC, Hemoglobin, RBC <br/ ><br>c. Liver Function Test: SGOT, SGPT, Total and Direct Bilirubin <br/ ><br>d. Renal Function Test: BUN Creatinine <br/ ><br>e. Serum electrolytes <br/ ><br>f. Cardiac Function: Troponin and ECG <br/ ><br>g. Percentage Mortality <br/ ><br>h. Cumulative incidence of serious adverse events <br/ ><br>i. Duration of hospitalization <br/ ><br>j. Duration of new oxygen use <br/ ><br>k. SOFA scoreTimepoint: Day 1 <br/ ><br>Day 3 <br/ ><br>Day 6 <br/ ><br>Day 10 <br/ ><br>Day 14