Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ozone therapy: 200 ml ozonized saline will be administered intravenously over 1 hour at 60 drops per minute for 8 days.
Control Intervention1: NA: NA
Sponsors
Bisleri charitable trust
NeuroGen Brain and Spine Institute
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Time to recovery on 8 point ordinal scale (Time to reach point 6-8) b. Time to Resolution of symptoms (Fever, cough, respiratory rate, shortness of breath) c. PAO2/FiO2 d. Chest X-ray â?? Day 1, 7 & 14 e. Inflammatory Biomarkers: C- reactive Protein,IL-6,Ferritin,LDH, D-Dimer e. Percentage of patients declining to serious stage at the end of 14 days f. Percentage of patients improving to mild stage at the end of 14 daysTimepoint: Day 1 Day 3 Day 6 Day 10 Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Oxygen saturation index: SPO2 / FiO2 b. Total blood count: WBC, Hemoglobin, RBC c. Liver Function Test: SGOT, SGPT, Total and Direct Bilirubin d. Renal Function Test: BUN Creatinine e. Serum electrolytes f. Cardiac Function: Troponin and ECG g. Percentage Mortality h. Cumulative incidence of serious adverse events i. Duration of hospitalization j. Duration of new oxygen use k. SOFA scoreTimepoint: Day 1 Day 3 Day 6 Day 10 Day 14 | — |
Countries
India
Contacts
Public ContactDr Jignasha Captain
Ozone Forum of India
Outcome results
None listed