Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Intervention Arm 1: 12 mg (200 microgram/kg)
Formulation: elixir
Route of administration: oral
Frequency: Only single dose
Intervention2: Intervention Arm 2: 24 mg (400 microgram/kg)
Sponsors
AIIMS New Delhi
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: diagnosed COVID19 patients admitted to AIIMS COVID facility Age > 18 years Informed consent Non-severe disease: Non-severe disease (Asymptomatic/ Mild disease OR moderate): SpO2>=90% on room air with presence of clinical features of dyspnea and/or hypoxia, fever, cough and/or Respiratory Rate more or equal to 24 per minute
Exclusion criteria
Exclusion criteria: Not giving written informed consent ALT/AST >5 times the upper limit of normal. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR Pregnant or breast feeding. Allergy to any study medication. Severe co-morbidity as per investigatorâ??s assessment Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. Prolonged QT interval ( >450 ms) Any other concomitant therapeutic trial Weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two co-primary outcomes 1. Frequency of RTPCR negativity at day 5 after drug administration 2. Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baselineTimepoint: Day 5 after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of clinical worsening in study group as compared to standard careTimepoint: till discharge or death;Frequency of serious adverse events in study group as compared to standard careTimepoint: till death or discharge;Qualitative and quantitative PCR for SARS CoV-2 in pharyngeal swab on days 0, 3, 5, and 7 (while hospitalized) in both armsTimepoint: days 0, 3, 5, and 7 (while hospitalized) ;Time to clinical resolution in study group as compared to standard careTimepoint: till discharge or death;Clinical status of subject at week 2 (on a 7-point ordinal scale) as follows: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death.Timepoint: Week 2 | — |
Countries
India
Contacts
Public ContactAnant Mohan
AIIMS New Delhi
Outcome results
None listed