Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: RT-PCR confirmed diagnosis of COVID-19 Provides written informed consent Male or non-pregnant, non-lactating female aged more than 18 years upto 60 years Participants with clinical syndrome associated with COVID -19 infection, presenting with either: Uncomplicated upper respiratory tract viral infection, with non-specific symptoms such as fever, cough, sore throat, nasal congestion, sneezing/running nose, loss of taste and smell, shortness of breath OR Mild pneumonia with no signs of severe pneumonia or need of supplemental oxygen therapy Able to take the drug orally and comply with study procedures
Exclusion criteria
Exclusion criteria: Participants with severe COVID-19 symptoms with respiratory rate > 30 breaths / min and severe respiratory distress or SpO2 Participants with altered mental state Laboratory abnormalities at Screening, including any of the following: (a)AST or ALT > 2.5 times ULN (upper limit of normal) (b) Absolute neutrophil count (c) Serum Creatinine > ULN (d) Total bilirubin > ULN Participants with active hepatitis, tuberculosis and definite bacterial or fungal infections Participants with multiple organ failure requiring ICU monitoring and treatment Participants of respiratory failure and requiring mechanical ventilation Participants with persistent vomiting Participants with shock Patient who have participated in another investigational study within 3 months prior to enrolment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.RT-PCR for Covid-19 2. IL-6 and TNF-alfa 3. IGg and IGm 4. CRPTimepoint: Day Zero, 7th day and day15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parametersTimepoint: Day Zero, 7th day and day15 | — |
Countries
India
Contacts
Jamia Hmadard