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 Study |
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
|
|
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. |