Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR). 4. Mild to Moderate disease (NEWS score Less than/equal to 8) 5. Can take oral medicines 6. Subject willing to abide by and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years and more than 65 years 2. Pregnancy and lactation 3. Severe or complicated course of COVID-19 disease 4. Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. 5. Any uncontrolled systemic disease, infection 6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. 7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in the clinical features from baseline to end of the study period 2.Change in immune markers (IL6, IL10 and TNF-alpha) from baseline to Day 5 and Day 10 Timepoint: Day 0,Day 5 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Adverse events (AEs), frequency and severity 2.Number of subjects who discontinue study due to adverse events Timepoint: Day 0 to Day 10 | — |
Countries
India
Contacts
Zum Heilen Diagnostic and Therapeutics Pvt. Ltd