The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
After being informed about the study and potential risks, all patients will give written informed consent and undergo a 1 day screening period to determine the eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally twice daily) plus standard treatment or placebo (taken orally,twice daily) plus standard treatment, both will be for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Hospital Juárez de México, OPD
Mexico City, Mexico
Viral Load
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Time frame: Day 0 to Day 8 or patient discharge day
Days of supplementary oxygen if apply
Assess length of supplementary oxygen
Time frame: Day 0 to day 28 or patient discharge day
Days of supplementary mechanical ventilation if apply
Assess length of mechanical ventilation
Time frame: Day 0 to day 28 or patient discharge day
Days of Hospitalization
Assess length of hospitalization
Time frame: Day 0 to day 28 or patients discharge day
Normalization of fever
Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Time frame: Day 0 to day 28 or patient discharge day
Normalization of oxigen saturation
Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Time frame: Day 0 to day 28 or patient discharge day
Number of deaths
Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Time frame: Day 0 to day 28 or patient discharge day
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Change in Serum creatinine levels
Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Time frame: Day 0 to day 28 or patients discharge day
Change in serum Troponin I
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Time frame: Day 0 to day 28 or patients discharge day
Change in serum aspartate aminotransferase levels
Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Time frame: Day 0 to day 28 or patients discharge day
Change in serum Creatine kinase-MB levels
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Time frame: Day 0 to day 28 or patients discharge day
Incidence of adverse event
Assess by incidence of grade 3, grade 4 and Serious adverse events
Time frame: Day 0 to day 28 or patients discharge day