Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate cases registered in CHC CBPACS above 18 years of age, with COVID 2019 (Confirmed by RT-PCR) Participants who can take medicines orally Patients willing to provide signed informed consent
Exclusion criteria
Exclusion criteria: Cases of severe vomiting which would make oral administration of medicine difficult. Cases of respiratory failure and requiring mechanical ventilation. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation Pregnant or lactating women Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below b) Number of patients showing â??clinical recoveryâ?? Timepoint: Baseline Day 8 Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test. 2.Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG) 3.Changes in liver enzymes, Renal functions 4.No of cases Reporting any ADR/AE 5.Number of participants referred with onset of complications Timepoint: Baseline 8th day 15th day | — |
Countries
India
Contacts
Chaudhary Bahm Prakash Ayurved Charak Sansthan, New Delhi