Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Purified aqueous extract of Cocculus hirsutus (AQCH) tablets: 400 mg thrice daily (every 8±1 hours), 10 days
Dosage and Administration: Thrice daily at least 30 min before meal, prefer
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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
Exclusion criteria
Exclusion criteria: 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 Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration 10.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing clinical improvement Clinical improvement defined as patient meeting discharge criteria OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale. Hospital Discharge Criteria is defined as resolution of symptoms, radiological improvement with a documented virological clearance in 2 samples at least 24 hours apart.Timepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration (days) of hospitalizationTimepoint: upto 28 days;Duration (days) of supplemental oxygen therapyTimepoint: upto 28 days;Number of deaths (All cause mortality)Timepoint: upto Day 28;Proportion of patients showing clinical improvementTimepoint: Day 7 and Day 28;Proportion of patients showing deterioration of clinical condition as assessed by at least 1 point worsening on 7 point ordinal scale (non-invasive ventilation, mechanical ventilation, ECMO or death)Timepoint: upto 28 days;Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)Timepoint: upto 28 days;Time (Days) to clinical improvementTimepoint: upto 28 days;Time to alleviation of coughTimepoint: upto 28 days;Time to first negative SARS-CoV-2 RT-PCR in in upper or lower respiratory tract specimenTimepoint: upto 28 days;Time to normalization of fever without use of antipyretics in last 24 hoursTimepoint: upto 28 days | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma laboratories Limited
Outcome results
None listed