CTRI Number |
CTRI/2020/05/025167 [Registered on: 14/05/2020] Trial Registered Prospectively |
Last Modified On: |
17/08/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Evaluation of Efficacy and Safety of Thymoquinone compared to Best supportive care in Patients with COVID-19 |
Scientific Title of Study
Modification(s)
|
Evaluation of Efficacy and Safety of Thymoquinone compared to Best supportive care in Patients with COVID-19. |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
0248-20, Version No: 3.0, Date : 07 july 2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mr Prashant Modi |
Address |
Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota
Ahmadabad GUJARAT 382481 India |
Phone |
07940202375 |
Fax |
07940202021 |
Email |
prashantmodi@lambda-cro.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Naman Shah |
Address |
Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota
Ahmadabad GUJARAT 382481 India |
Phone |
07940202389 |
Fax |
07940202021 |
Email |
namanshah@lambda-cro.com |
|
Details Contact Person Public Query
|
Name |
Mr Prashant Modi |
Address |
Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota
Ahmadabad GUJARAT 382481 India |
Phone |
07940202375 |
Fax |
07940202021 |
Email |
prashantmodi@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
Intas Pharmaceuticals Ltd.Corporate Office Building, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380 054, Gujarat, India |
|
Primary Sponsor
|
Name |
Intas Pharmaceuticals Ltd |
Address |
Corporate Office Building, Near Sola Bridge,
S.G. Highway, Thaltej, Ahmedabad – 380 054,
Gujarat, India.
Tel. No.:917939837981
|
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 4 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rashmi Chovatia |
CIMS Hospital Pvt Ltd. |
Opp. Panchamrut Bunglows,
Nr. Shukan Mall,
Off Science City Road, Sola - 380060, India.
Ahmadabad |
09824839300
dr.chirag76@yahoo.com |
Dr Dhaiwat Shukla |
Samras Hostel |
Room no:NA,132 feet ring road, University Area, - 380001,India Ahmadabad |
08980024107
dr.dhaiwatshukla89@gmail.com |
Dr Vinay Bhomia |
Sanjivani Super Speciality Hospital Pvt. Ltd. |
Department of Clinical Research, Room No. NA, 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, 380015, India Ahmadabad |
09825007385
drvinaybhomia@gmail.com |
Dr Janakkumar R Khambholja |
Sardar Vallabhbhai patel Institute of Medical Science & Research (SVPIMSR) |
Department of medicine, Room no:NA, Ellisbridge-380006,India
Ahmadabad |
09825447813
kham_jak@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 4 |
Name of Committee |
Approval Status |
Ethics Committee of Care Institute of Medical Sciences,CIMS Hospital Pvt. Ltd,Dr. Rashmi Chovatia |
Approved |
Institutional Ethics Committee,Smt. NHL, Municipal Medical College,Dr. Janakkumar R. Khambholja |
Approved |
Sangini Hospital Ethics Committee, Dr. Dhaiwat Shukla |
Approved |
Sanjivani Hospitals Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
best supportive care |
Best supportive care will be as defined in Guidelines on Clinical Management of COVID-19 issued by MOHFW. |
Intervention |
Thymoquinone 50 mg tablet as an add on to best supportive as per guidelines of clinical management of COVID-19 as issued by MOHFW. |
Dose : 50 mg once daily for 14 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Ability to provide signed and dated informed consent.
2. Male or female aged ≥ 18 and ≤65 years of age.
3. Patients who meets the following criteria: a. With confirmed COVID-19 infection as defined below
i. Has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) or other commercial or public health assay in any specimen, collected <72 hours prior to enrollment; AND
ii. Asymptomatic patients without any signs or symptoms as defined in clinical management guidelines for COVID-19 infection issued by the Ministry of Health and Family Welfare (MOHFW); OR Mild (uncomplicated) illness of any duration not requiring hospitalization, and without extreme shortness of breath or severe prostration meeting following criteria:
1. Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
2. No signs of any serious lower airway disease as defined in clinical management guidelines for COVID-19 infection issued by MOHFW AND
3. RR<20, HR <90, oxygen saturation (pulse oximetry) >93% on room air at screening. |
|
ExclusionCriteria |
Details |
1. Severe COVID-19 including but not limited to:
a. respiratory failure (defined by endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
b. Multiple organ dysfunction/failure
c. Systolic BP <90 mmHg or Diastolic BP < 60 mm Hg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support
2. Confirmed or suspected diagnosis of Acute Respiratory Distress Syndrome (ARDS) at screening
3. History of severe chronic respiratory disease and requirement for long-term oxygen therapy
4. Expected need for mechanical ventilation within the next 24 hours
5. Expected survival of less than 96 hours at the time of presentation
6. Receiving renal replacement therapy/dialysis
7. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies
8. Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry
9. Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
10. Patients who have received organ transplantation or major surgery in the past 6 months.
11. Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or Patients with child-Pugh grade C cirrhosis.
12. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the Patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To characterize virologic and clinical response of Thymoquinone in patients diagnosed with COVID-19
|
1. Virologic outcome
a. Change in positive COVID-19 status on day 8 and day 15
2. Clinical outcomes
a. Proportion of Patients on WHO progression scale 0 to 10 on day 8 and day 15. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To monitor the safety of the patients who are exposed to the Lipid based Thymoquinone |
1.Clinical Outcomes
a.Change from baseline in COVID-19 symptom severity at day 8 and day 15.
2.Immunological outcomes
on Day 1, Day 8 and Day 15 after drug administration
3 Safety Endpoints:
throughout the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100" Sample Size from India="100" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
17/05/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
Brief Summary
|
This is an open label, prospective, two arm, parallel, study to evaluate efficacy and safety of Thymoquinone compared to Best supportive care in Patients with COVID19. Eligible patients having confirmed diagnosis of COVID-19 as defined in inclusion criteria, will be assigned to treatment arm 1 (Cohort A) or treatment arm 2 (Cohort B). Cohort A patients will receive Thymoquinone 50 mg once daily for 14 days along with best supportive care defined in Guidelines on Clinical Management of COVID19 issued by MOHFW. Cohort B patients will receive best supportive care only. Patients being asymptomatic or having mild disease as per eligibility criteria will not require hospitalization but could have been quarantined in hospital. MOHFW guidelines will be followed for any hospitalization criteria. |