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CTRI Number  CTRI/2020/07/026671 [Registered on: 18/07/2020] Trial Registered Prospectively
Last Modified On: 18/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ozone therapy]  
Study Design  Single Arm Trial 
Public Title of Study   Ozone Therapy for Covid 19 patients 
Scientific Title of Study   A pilot study for treatment of COVID-19 patients in moderate stage using intravenous administration of ozonized saline as an adjuvant treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Sharma  
Designation  Director 
Affiliation  NeuroGen Brain and Spine Institute 
Address  Chairmans room, 2nd floor, Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai, India.

Thane
MAHARASHTRA
400706.
India 
Phone  9820046663  
Fax    
Email  alok276@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mili Arpan Shah 
Designation  President 
Affiliation  Ozone Forum of India 
Address  President of ozone forum of India, Training and education. 3rd Flr Bisleri Tower Off Western Express Highway, Andheri - Kurla Rd, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9819376454  
Fax    
Email  drmilishah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jignasha Captain 
Designation  Director 
Affiliation  Ozone Forum of India 
Address  Director-Ozone Forum of India, Clinical Head, 3rd Flr Bisleri Tower Off Western Express Highway, Andheri - Kurla Rd, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9967608029  
Fax    
Email  drjigna911@hotmail.com  
 
Source of Monetary or Material Support  
Bisleri Charitable Trust C/o, parle bisleri pvt.Ltd western express highway, andheri (east), mumbai- 400099 
NeuroGen Brain and Spine Institute Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India 
 
Primary Sponsor  
Name  Bisleri charitable trust 
Address  Bisleri charitable trust C/o, parle bisleri pvt.Ltd western express highway, andheri (east), mumbai- 400099 
Type of Sponsor  Other [Charitable Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NeuroGen Brain and Spine Institute  Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Sharma  NeuroGen Brain and Spine Institute  Chairmans Room, 2nd Floor,Plot 19, Sector 40, Nerul (W), Next Seawoods Grand Central Station. Off Palm Beach Road. Navi Mumbai- 400706. India
Thane
MAHARASHTRA 
9820046663

alok276@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Neurogen Brain and Spine Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Ozone therapy  200 ml ozonized saline will be administered intravenously over 1 hour at 60 drops per minute for 8 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 – 65 years 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 – 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 days 
Day 1
Day 3
Day 6
Day 10
Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
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 score 
Day 1
Day 3
Day 6
Day 10
Day 14 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

India has 13,295 active COVID-19 cases with death toll reaching 519 as of 19th April 2020. There is an urgent need to explore novel options of treatment for COVID-19. Despite standard treatment, 20% of patient’s progress to moderate stage out of which 5% deteriorate to severe stage and the mortality rate is 3%. Ozone therapy, an integral part of Naturopathic medicine extensively been used for treating chronic diseases since many years.COVID-19 exhibits multimodal pathology by inducing a ‘cytokine storm’ primed to exacerbate the inflammatory response, depleted oxygenation and viral infection leading to pneumonia, edema, respiratory failure and eventually, death. Ozone therapy has been shown to mitigate inflammatory cytokine storms in a variety of disorders, including respiratory disorders. It has potent antiviral, anti-inflammatory and immunomodulatory effects. Recent reports from Balearic Islands reveals that no new cases of COVID-19 following the administration of ozone therapy by a clinic in Spain. Several clinical trials are under way for testing the safety and efficacy of ozone therapy against COVID-19, with no reports of adverse events so far. The present study is proposed to evaluate the utility of ozone therapy as an adjuvant along with standard care in control of disease progression in patients COVID-19.

 
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