DMMETCOV19: Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days |
Drug: metformin glycinate
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Other Names:
|
| Placebo Comparator: Placebo Placebo tablets bid (PO) plus standard treatment for 14 days |
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Viral Load [Day 0 to Day 8 or patient discharge day]
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Secondary Outcome Measures
- Days of supplementary oxygen if apply [Day 0 to day 28 or patient discharge day]
Assess length of supplementary oxygen
- Days of supplementary mechanical ventilation if apply [Day 0 to day 28 or patient discharge day]
Assess length of mechanical ventilation
- Days of Hospitalization [Day 0 to day 28 or patients discharge day]
Assess length of hospitalization
- Normalization of fever [Day 0 to day 28 or patient discharge day]
Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
- Normalization of oxigen saturation [Day 0 to day 28 or patient discharge day]
Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
- Number of deaths [Day 0 to day 28 or patient discharge day]
Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
- Change in Serum creatinine levels [Day 0 to day 28 or patients discharge day]
Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
- Change in serum Troponin I [Day 0 to day 28 or patients discharge day]
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
- Change in serum aspartate aminotransferase levels [Day 0 to day 28 or patients discharge day]
Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
- Change in serum Creatine kinase-MB levels [Day 0 to day 28 or patients discharge day]
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
- Incidence of adverse event [Day 0 to day 28 or patients discharge day]
Assess by incidence of grade 3, grade 4 and Serious adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 18 years old
-
Ability to understand and the willingness to sign a written informed consent document before any study procedure
-
Metabolic syndrome or type 2 diabetes
-
Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
-
Hospitalized patient.
-
Radiographic evidence of pulmonary infiltrates
Exclusion Criteria:
-
Participation in any other clinical trial of an experimental treatment for COVID-19
-
Evidence of multi-organ failure
-
Require mechanical ventilation before randomization
-
Pregnant patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Juárez de México, OPD | Mexico City | Mexico | 07760 |
Sponsors and Collaborators
- Laboratorios Silanes S.A. de C.V.
Investigators
- Principal Investigator: Fausto González-Villagrán, MD, Hospital Juárez de México, OPD
Study Documents (Full-Text)
None provided.More Information
Publications
- Glucophage Product Monograph (metformin hydrochloride) Sanofi-Aventis Canada. Rev.28th October 2008
- NDA 20-357, Glucophage. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
- NDA 21-842, Actoplus met. US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
- Revert F, Ventura I, Martínez-Martínez P, Granero-Moltó F, Revert-Ros F, Macías J, Saus J. Goodpasture antigen-binding protein is a soluble exportable protein that interacts with type IV collagen. Identification of novel membrane-bound isoforms. J Biol Chem. 2008 Oct 31;283(44):30246-55. doi: 10.1074/jbc.M805026200. Epub 2008 Sep 4.
- SIL-30000-II(1)