Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Group A (Metformin Arm): Metformin 500 mg twice daily orally for 28 days + standard-of-care
Intervention2: Group B (Atorvastatin Arm): Atorvastatin 10 mg twice daily orally for 28 days
Sponsors
All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad
Eligibility
Inclusion criteria
Inclusion criteria: 18 to 50 years of age of either gender A â??confirmedâ?? COVID-19 case as per the latest MoHFW, GoI guidelines (Clinical management protocol for COVID-19 in Adults; Version 6, 24th May 2021) Patients with uncomplicated upper respiratory tract infection with mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache, vomiting, diarrhea, loss of taste and smell Patients without shortness of breath and respiratory rate below 24/min Patients with normal saturation (SpO2 >= 94% on room air) Willing to self-record the daily vital parameters Willing to communicate regularly over phone or in person
Exclusion criteria
Exclusion criteria: Moderate and severe COVID-19 patients Patients with abnormal chest imaging Patients who are administered with anti-SARS-CoV-2 monoclonal antibodies Patients who are on metformin or atorvastatin currently and in the past one month Type 2 diabetes mellitus and pre-diabetes patients Patients with primary and/or secondary dyslipidemia Patients who are on corticosteroids or immunosuppressants Patients with history of known hypoglycemic episodes in the past Patients with clinically significant lung, heart, liver or kidney disease Patients on alternative systems of medicine Patients with known allergic history to metformin or atorvastatin Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients in the metformin, atorvastatin, metformin + atorvastatin, and standard-of-care arms getting admitted (hospitalized) in the next 4 weeks. â?¢ Proportion of patients in the metformin, atorvastatin, metformin + atorvastatin, and standard-of-care arms with SpO2 declining to 93% or lower in the next 4 weeks.Timepoint: weekly for the next 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Time to symptomatic improvement in the metformin, atorvastatin, metformin and atorvastatin, and standard-of-care arms in the next 4 weeks. â?¢ Proportion of patients in the metformin, atorvastatin, metformin and atorvastatin, and standard-of-care arms developing adverse effects in the next 4 weeks. Timepoint: weekly for the next 4 weeks | — |
Countries
India
Contacts
Public ContactGerard Marshall Raj
All India Institute of Medical Sciences (AIIMS) Bibinagar, Hyderabad
Outcome results
None listed