COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62503

Gerard Marshall Raj

drgmr1111@gmail.com

2021-11-16

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

18 to 50 years of age of either gender <br/ > 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) <br/ > 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 <br/ > Patients without shortness of breath and respiratory rate below 24/min <br/ > Patients with normal saturation (SpO2 â?¥ 94% on room air) <br/ > Willing to self-record the daily vital parameters <br/ > Willing to communicate regularly over phone or in person <br/ >

Moderate and severe COVID-19 patients <br/ > Patients with abnormal chest imaging <br/ > Patients who are administered with anti-SARS-CoV-2 monoclonal antibodies <br/ > Patients who are on metformin or atorvastatin currently and in the past one month <br/ > Type 2 diabetes mellitus and pre-diabetes patients <br/ > Patients with primary and/or secondary dyslipidemia <br/ > Patients who are on corticosteroids or immunosuppressants <br/ > Patients with history of known hypoglycemic episodes in the past <br/ > Patients with clinically significant lung, heart, liver or kidney disease <br/ > Patients on alternative systems of medicine <br/ > Patients with known allergic history to metformin or atorvastatin <br/ > Pregnant or breastfeeding woman

4

All India Institute of Medical Sciences AIIMS Bibinagar Hyderabad

18

50

India

Mild disease at enrollment

1: Mild disease at enrollment

272

â?¢ Proportion of patients in the metformin; atorvastatin; metformin + atorvastatin; and standard-of-care arms getting admitted (hospitalized) in the next 4 weeks. <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

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 4

[{"arm_notes": "", "treatment_id": 795, "treatment_name": "Metformin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2365, "treatment_name": "Atorvastatin+metformin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]