Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: CLEVIRA tablet twice daily for 14 days: Composition of one CLEVIRA tablet includes extracts namely:
Erandakarkati (Carica papaya)-Lf. â?? 100mg,
Mahanimba (Melia azedarach)-Lf. â?? 100
Sponsors
Apex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to performing study procedures. 2. Males and females between the age of 18-50 years. 3. Mild to moderate COVID-19 associated disease as defined by the WHO. 4. Hospitalized patient. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR. 6.Illness of any duration and febrile/afebrile. Febrile-defined as temperature >= 36.6 °C armpit, >= 37.2 °C oral, or >= 37.8 °C rectal documented within 48 hours of consent.
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited 3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) 4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR 5.Pregnant women or women who are breastfeeding 6.Immunocompromised patients taking medication upon screening 7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a.Time taken for clinical recovery, which is defined as; 1. Normalization of pyrexia and body pain 2. Respiratory rate less than 24/minute 3.Spo2 rate greater than 94% 4. Relief from cough and maintenance of above for more than 72 hours. b.Proportion of patients with swabs negative for COVID19 in RT PCR at day 5, 10 and 15 c.Reduction of Viral Load. Timepoint: At day 5, day 10 and day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Clinical status of subject (on a 6 point ordinal scale). 1. Discharged having reached clinical recovery criteria 2. Hospital admission, but not requiring supplemental oxygen 3. Hospital admission, requiring supplemental oxygen 4. Hospitalized, on non-invasive ventilation or high flow oxygen devices 5. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Death. b.All cause of death/mortality c.Duration of hospitalization d.Adverse events if anyTimepoint: At day 5, day 10 and day 15 | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
Madras Medical College
Outcome results
None listed