Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Asymptomatic, Mild to moderate cases registered in A & U, Tibia hospital above 18-60 years of age, with COVID 2019 (Confirmed by RT-PCR or Rapid Antigen Test) quarantined at identified hospital set up. 2.Participants who can take medicines orally 3.Patients willing to provide signed informed consent
Exclusion criteria
Exclusion criteria: 1.Cases of severe vomiting which would make oral administration of medicine difficult. 2.Cases of respiratory failure and requiring mechanical ventilation. 3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. 4.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 5.Pregnant or lactating women 6.Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. 2. Changes in liver enzymes, Renal functionsTimepoint: 1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. [Time frame: 8th day or 15th day] 2. Changes in liver enzymes, Renal functions [Time frame: 8th day or 15th day] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. 2.Number of symptomatic patients showing â??clinical recoveryâ??. Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG).Timepoint: 1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. [time frame:7th day,14th day if RTPCR positive-on 8th or 9th Day] Time frame: 8th day or 15th day 2.Time frame: 8th day (after intervention of 7 days) or 15th day( in case intervention for 14 days). | — |
Countries
India
Contacts
CCRAS