The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.
After being informed about the study and potential risks, all patients giving written
informed consent will undergo a 1 day screening period to determine eligibility for study
entry. At day 0, patients who meet the eligibility requirements will be randomized in a
double blind manner (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 for 14 days.
Drug: Metformin Glycinate
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
Other Name: DMMET
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
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. Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the
polymerase chain reaction (PCR) test ≤ 4 days before randomization.
4. Hospitalized
5. 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
5. Patients with kidney failure, cancer and among other conditions that due to their
treatment and / or baseline condition, affect the distribution, bioavailability and
elimination of the studied drug
The American British Cowdray Medical Center, I.A.P
Mexico City, Mexico
Janet Silvia M Aguirre, MD, Principal Investigator
The American British Cowdray Medical Center. I.A.P.