Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
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.
Sponsors
Indus Biotech Limited
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female with >= 18 years and 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 3. Patient is either requiring hospitalisation for COVID-19 or agrees to maintain a home or other quarantine as recommended by the study Investigator at the time of randomization in the study. 4. Patient with WHO Clinical Progression Scale score of 2 to 5
Exclusion criteria
Exclusion criteria: 1. Patients with a known history of allergy or intolerance to Cinnamon. 2. Participation in another concurrent clinical trial for COVID-19 or in any other trial within the 6 months prior to this study enrolment. 3. Patients classified as severe or critical COVID-19 patients as per AYUSH guidelines. 4. Patients with pre-existing respiratory conditions, or with severe primary respiratory disease or other pneumonia, who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion. 5. Patients with other serious diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion. 6. Patients requiring mechanical ventilation at screening. 7. Patients with uncontrolled and unstable comorbid conditions. 8. Immunocompromised individuals or patients who are already receiving immunosuppressant therapies. 9. Patients who are currently on or may require parenteral nutrition during the course of the study. 10. Female patients who are breastfeeding or pregnant at the time of enrolment in the study. 11. Female patients of childbearing potential who, within 4 weeks prior to study enrolment, did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the study period. 12. Any medical or other condition that in the opinion of the Investigator would preclude the patientâ??s participation in the study. 13. Current abuse of alcohol; and current or past (last 12 months) abuse of drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited
Outcome results
None listed