Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2, Metabolic Syndrome, Type 2 Diabetes

Intervention / Treatment
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* Drug: metformin glycinate
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin glycinate<br>620 mg bid (PO) plus standard treatment for 14 days | Drug: metformin glycinate<br>* Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days<br>* Other names: DMMET;|
| Placebo Comparator: Placebo<br>Placebo tablets bid (PO) plus standard treatment for 14 days | Drug: Placebo oral tablet<br>* Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load | Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate | Day 0 to Day 8 or patient discharge day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of supplementary oxygen if apply | Assess length of supplementary oxygen | Day 0 to day 28 or patient discharge day | 
| Days of supplementary mechanical ventilation if apply | Assess length of mechanical ventilation | Day 0 to day 28 or patient discharge day | 
| Days of Hospitalization | Assess length of hospitalization | 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 | 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 | 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 | Day 0 to day 28 or patient discharge day | 
| Change in Serum creatinine levels | Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl | 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 | 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 | 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 | 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 | Day 0 to day 28 or patients discharge day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV 2, Metabolic Syndrome, Type 2 diabetes, Severe Acute Respiratory Syndrome, Metformin glycinate