FULL DETAILS (Read-only)

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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  

Close