A study to evaluate the effect and safety of a phytopharmaceutical drug in treatment of Coronavirus infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025397
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Subjects will be included in the study if they meet all of the following criteria:
1. Patient who provides written informed consent
2. Male or non-pregnant, non-lactating female patient aged >= 18 and <= 75 years (both inclusive)
3. Patients with body temperature > 37.3â?? with cough/ shortness of breath
4. Patient with moderate COVID-19 infection having either one of the following criteria
a. PaO2/ FiO2: 200-300
OR
b. Respiratory Rate > 24/min and SaO2/ SpO2 <= 93% on room air
5. Patient with RT-PCR confirmed diagnosis of COVID-19
6. Patient who is able to take the drug orally and comply with study procedures
7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry
Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1. Patient with persistent vomiting
2. Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections
3. Patient with altered mental state
4. Patient with multiple organ failure requiring ICU monitoring and the treatment
5. Patient with respiratory failure and requiring ventilation
6. Patient with history of retinopathy or macular degeneration
7. Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
8. Patient with prolonged QTc-interval at baseline ECG ( >450 ms in males or > 470 ms in females)
9. Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration
10. Patient with history of hypersensitivity towards any drug of standard of care
11. Patient with history of evidence of chronic interstitial infiltration at imaging
12. Patient with history of hospitalization within the past six months for respiratory failure
13. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., heart failure, COPD, hypertension, liver disease, chronic respiratory failure, chronic kidney disease, diabetes, anaemia etc.) that, in the opinion of the Investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
14. Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
15. Patient who has received specific antiviral drugs ritonavir/ lopinavir, or chloroquine,
hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week prior to admission
16. Patient who has participated in another investigational study within 3 months prior to enrolment in this study.
17. Investigators, study personnel, sponsorâ??s representatives and their first degree relatives.
Note: Persistent vomiting is more than three episodes of vomiting in 12 hours, preventing adequate oral
hydration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method