How does administering Metformin (a key drug for diabetes) and Atorvastatin (a key drug for cholesterol reduction) help in mild COVID-19 disease?

Phase 4

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/11/038065

Lead Sponsor: All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Proportion of patients in the metformin, atorvastatin, metformin + atorvastatin, and standard-of-care arms getting admitted (hospitalized) in the next 4 weeks. <br/ ><br>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 Outcome Measures

Name	Time	Method
â?¢Time to symptomatic improvement in the metformin, atorvastatin, metformin and atorvastatin, and standard-of-care arms in the next 4 weeks. <br/ ><br>â?¢Proportion of patients in the metformin, atorvastatin, metformin and atorvastatin, and standard-of-care arms developing adverse effects in the next 4 weeks. <br/ ><br>Timepoint: weekly for the next 4 weeks