Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Lupin Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol. 2. Subjects with mild COVID-19 symptoms (only for Treatment Group). Subjects with uncomplicated upper respiratory tract infection (without shortness of breath or hypoxia [normal saturation i.e. SpO2 levels �94%]), may have mild grade of fever ( 3. Participants staying with COVID-19 subject in the same household (only for Prevention Group). 4. Participants who have tested positive for RT-PCR (for treatment group only) and negative for RT-PCR (for prevention group only) within 5 days of enrollment
Exclusion criteria
Exclusion criteria: 1. Subjects with moderate to severe disease 2. Subjects requiring or likely requiring oxygen support in the opinion of investigator 3. Any clinical contraindications, as judged by the investigator 4. Pregnant or lactating females 5. Subjects with prior history of confirmed COVID-19 infection with RT-PCR in last 3 months. 6. Subjects who are currently hospitalized or need for hospitalization 7. Subjects with blocked nose requiring intranasal decongestant 8. Any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group. 2. Proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group Timepoint: Screening Visit (Up to 5 days), Baseline Visit (Day 0), Day 2, Day 4, Day 7, and day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. No of days required for complete clinical recovery and Proportion of patients with complete clinical recovery 2. Safety and tolerability in terms of adverse events, serious adverse events Timepoint: Screening Visit (Up to 5 days), Baseline Visit (Day 0), Telephonic follow up (Day 2 to day 6), Day 7, Telephonic follow up (Day 8 to Day 13) and day 14. | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed