CTRI/2021/11/038065Not yet recruitingPhase 4
Effect of Metformin and Atorvastatin as Add-On Therapy in Mild COVID-19 Patients â?? an Open Label Randomized Controlled Trial
All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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