Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 or less than 75 years at time of signing Informed Consent Form. COVID positive by RTPCR Cases that have been assigned as mild or very mild or asymptomatic cases of COVID. Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI). No difficulty in swallowing oral medications. Must agree not to enroll in another study of an investigational agent prior to completion of study.
Exclusion criteria
Exclusion criteria: Allergies, known to be allergic to research drugs or drug excipients; Subject weight is less than 40 kg Pneumonia with/without signs of severe disease. COVID Cases with ARDS or Septic shock. Patients who have participated in other clinical trials within 1 month. Known patients with impaired renal function (estimated creatinine clearance During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level 5 times the upper limit of normal range (ULN) or-ALT or AST more than 3 times ULN and total bilirubin levels more than 2 times ULN. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of Immunological panel CD4, CD8, NK cell panel CD16/CD56 Serum CRP levels Inflammatory mediators like IL-6 and TNF alpha Change in clinical symptom presentation in Fever, Cough, breathlessness, fatigue and myalgia, loss of taste and smell on 5 point ordinal Timepoint: From Baseline to End of the Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in random blood sugar Hematological parameters like WBS, RBC and platelet count etc. Requirement of admission to Dedicated COVID Hospital Duration of hospital admission Requirement of ICU admission Timepoint: from Baseline to End of the Study | — |
Countries
India
Contacts
Shree Baidyanath Ayurved Bhawan Pvt. Ltd.