Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Test Product: 2 capsules of Virowin 700 mg capsules, orally, thrice a day for 14 days and 1 capsule of Energy Z capsules, orally, twice a day for 14 days
Control Intervention1: Standard
Sponsors
Amulya Herbs
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 2. Patients with RT-PCR confirmed diagnosis of COVID-19 3. Patients with mild to moderate COVID-19 infection 4. Subjects willing to give written informed consent 5. Subjects able to take the Product orally and comply with the study protocol 6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry
Exclusion criteria
Exclusion criteria: 1. Patients with persistent vomiting 2. Critically ill patients 3. Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections 4. Patients with altered mental state 5. Patients with multiple organ failure requiring ICU monitoring and treatment 6. Patients with respiratory failure and requiring mechanical ventilation 7. Patients with shock 8. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. 9. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. 10. Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission 11. Patient who have participated in another investigational study within 3 months prior to enrolment in this study 12. Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives. 13. Pregnant subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time until cessation of oral shedding of SAARS-CoV-2 virus 2. Clinical cure based on Clinicianâ??s assessment of symptoms, which include recovery from fever (with or without chills), cough, difficulty in breathing, sore throat, body ache, nasal congestion, gastrointestinal symptoms, fatigueTimepoint: Day1, Day 7 and Day14 | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityTimepoint: Day 14;Changes in Blood oxygen saturation level (Oximeter reading)Timepoint: Up to Day 14;Duration of hospitalizationTimepoint: Day of discharge;Improvement in the clinical lab variables including total leucocyte count, absolute leucocyte count, ESR, erythrocyte count, and markers including Hs CRP and IL-2 from baseline to end of the study.Timepoint: Day1 and Day 14.;Proportion of participants in each group with need for mechanical ventilationTimepoint: Up to Day 14;Proportion of participants in each group with normalization of feverTimepoint: Day 7 and Day 14;Proportion of patients in both the groups needing ICU careTimepoint: Up to Day 14;Proportion of patients in each group with need of oxygen therapy.Timepoint: Up to Day 14;Radiological improvement as measured by Chest X-raysTimepoint: Day1 and Day 14.;Response of the patients as assessed by the subjectâ??s global assessment of symptoms like cough, sore throat, nasal congestion, fever with or without chills, body ache, difficulty in breathing, gastrointestinal symptoms and fatigue (if symptomatic at baseline)Timepoint: Daily (Day 1 to Day 14);Symptoms durationTimepoint: Up to Day 14;Time to fever normalization (if febrile at baseline)Timepoint: Day 3, Day 7 and Day 14;Time to first negative SARS-CoV-2 PCR in NP swab Timepoint: Day of discharge/Day 14 | — |
Countries
India
Contacts
Public ContactDr Parikshit Bansal
Pharexcel Consulting
Outcome results
None listed