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.
Drug: metformin glycinate
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Other Name: DMMET
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Other Name: Placebo
Inclusion Criteria:
1. ≥ 18 years old
2. Ability to understand and the willingness to sign a written informed consent document
before any study procedure
3. Metabolic syndrome or type 2 diabetes
4. Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the
Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
5. Hospitalized patient.
6. Radiographic evidence of pulmonary infiltrates
Exclusion Criteria:
1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Evidence of multi-organ failure
3. Require mechanical ventilation before randomization
4. Pregnant patients
Hospital Juárez de México, OPD
Mexico City, Mexico
Fausto González-Villagrán, MD, Principal Investigator
Hospital Juárez de México, OPD