Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome 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 the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.

Detailed Description
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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.

Official Title
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Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients 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

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 Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization. Hospitalized 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 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

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: Metformin glycinate 620 mg bid (PO) for 14 days plus standard treatment Control group: placebo bid (PO) for 14 days plus standard treatment Comparator: Placebo Placebo pill bid (PO) for 14 days plus standard treatment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin glycinate<br>620 mg bid (PO) for 14 days plus standard treatment | Drug: Metformin Glycinate<br>* Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment<br>* Other names: DMMET;|
| Placebo Comparator: Placebo<br>Placebo tablet bid (PO) for 14 days plus standard treatment | Drug: Placebo oral tablet<br>* Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment<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 28 or patient discharge day | 
| consciousness level | Clinical status assessed by measurement of consciousness level: alertness | Day 0 to Day 28 or patient discharge day | 
| temperature | Clinical status assessed by measurement of axillary body temperature in °C: <37.2. | Day 0 to Day 28 or patient discharge day | 
| systolic blood pressure | Clinical status assessed by measurement of systolic blood pressure in mmHg: >90. | Day 0 to Day 28 or patient discharge day | 
| Oxigen saturation | Clinical status assessed by measurement of oxygen saturation in %: >90. | Day 0 to Day 28 or patient discharge day | 
| Heart rate | Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm. | Day 0 to Day 28 or patient discharge day | 
| respiratory rate | Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm, | Day 0 to Day 28 or patient discharge day | 
| Days of hospitalization | Assess length of hospitalization | Day 0 to Day 28 or patient discharge day | 
| Days of supplementary oxygen if applies | Assess length of supplementary oxygen | Day 0 to Day 28 or patient discharge day | 
| Days of supplementary mechanical ventilation | Assess length of mechanical ventilation | Day 0 to Day 28 or patient discharge day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4) | Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs) | Day 0 to Day 28 or patient discharge day | 
| Changes in laboratory test results | Changes in serum levels from security laboratories compared to baseline levels and between groups. | Day 0 to Day 28 or patient discharge day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-COV 2, Severe acute respiratory syndrome