A phase II study to evaluate safety and effectiveness of IND02 Capsules in patients who are hospitalized SARS-CoV2 positive patients with mild to moderate COVID-19 at COVID management centres offering Ayurvedic care

INTERVENTION: Intervention1: Study Drug: IND02 [Cinamuneâ?¢] capsules 500 mg Placebo: Placebo capsules 500 mg (containing all excipients except active ingredient) to be provided by Indus Biotech Pvt. Ltd., India. : Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment): â?¢ Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3 â?¢ days â?¢ Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days Intervention2: IND02 [Cinamuneâ?¢] capsules 500 mg : Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment): ‐ Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3 ‐ days ‐ Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days Control Intervention1: Placebo capsules 500 mg (containing all excipients except active ingredient) to be provided by Indus Biotech Pvt. Ltd., India.: Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment): ‐ Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3 ‐ days ‐ Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: ‐ Median time to recovery using WHO Clinical Progression Scale between the test and placebo groupsTimepoint: From date of randomization until 15 days of treatment and ; additional 7 days of follow‐u ; INCLUSION CRITERIA: 1. Male or Female with â?¥ 18 years and < 60 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule. 2. Patient with confirmed diagnosis for COVID‐19, and who has tested positive for infection with SARS‐CoV2 virus. Note: COVID‐19 infection confirmed by RT‐PCR following ICMR/WHO protocol in â?¤ 5 days prior to randomization in the study. 3. Patient is requiring hospitalisation for COVID‐19 at the time of randomization in the study. 4. Patient with WHO Clinical Progression Scale score of 3 to 5 SECONDARY OUTCOME: Mean change in scores as assessed by WHOQOL‐BREF QuestionnaireTimepoint: Daily from randomisation until 15 days of treatment and ; additional 7 days of follow‐up ; Mean change in scores of Immune Status and Function as assessed by Immune Status Questionnaire (ISQ).Timepoint: Daily from randomisation until 15 days of treatment and ; additional 7 days of follow‐up ; Mean number of mortality cases from baseline between the test and placebo groups.Timepoint: From date of randomization until 15 days of treatment and ; additional 7 days of follow‐up ; Mean number of patients requiring mechanical ventilation use from baseline between the test and placebo groups.Timepoint: Daily from randomisation until 15 days of treatment and ; additional 7 days of follow‐up ; Mean number of patients with clinical improvement using WHO Clinical Progression Scale between the test and placebo groups.Timepoint: From date of randomization until 15 days of treatment and ; additional 7 days of follow‐up ; Mean number of patients with confirmed negative RT‐PCR result between the test and placebo groups.Timepoint: From day of first testing positive to the day of ; confirmation of testing negative ; Mean number of patients with improvement in SpO2 by Pulseoximetry from baseline between the test and placebo groups.Timepoint: Daily from randomisation until 15 days of treatment and ; additional 7 days of follow‐up ; Mean number of patients with progress from mild/moderate to severe or critical stages of the disease using the WHO Clinical Progression ScaleTimepoint: From day of first testing positive to the day of ; confirmation of progression of disease ; Mean number of patients with recovery using WHO Clinical Progression Scale between the test and placebo groups.Timepoint: From date of randomization until 15 days of treatment and ; additional 7 days of follow‐up ; Median duration (days) of hospitalization from baseline between the test and placebo groups.Timepoint: From date of randomization until the date of hospital ; discharge or date of death from any cause, whichever came first, assessed ; up to 15 days and additional 7 days of follow‐up ; Median time required for clinical improvement using WHO Clinical Progression Scale between the test and placebo groups.Timepoint: From date of randomization until 15 days of treatment and ; additional 7 days of follow‐up ; Median time required to test COVID‐19 negative.Timepoint: From day of first testing positive to the day of confirmation of testing negative