Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2020
INTERVENTION: 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 Treatment: As per hospital protocol for COVID‐19. Dose: As per the hospital policy. CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 INCLUSION CRITERIA: 1. Gender: Either male or non‐pregnant, non‐lactating female aged > 18‐70 < years (both inclusive). 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
Epistemonikos ID: 7137bd3d38d243af4d50437c617dbd3bd3a03285
First added on: Aug 22, 2020