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COMPLETEDPHASE2

Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.

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

NCT04625985•Laboratorios Silanes S.A. de C.V.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

The American British Cowdray Medical Center, I.A.P

Mexico City, Mexico

Key Dates

Start Date

July 14, 2020

Primary Completion Date

March 8, 2021

Completion Date

March 18, 2021

Last Updated

April 8, 2021

Enrollment

ACTUAL participants

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Metformin Glycinate

DRUG

Placebo oral tablet

DRUG

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

NCT05677893

Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)

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COMPLETEDPHASE2/PHASE3

Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial

NCT04466241

COVID-19COVID-19 Drug Treatment+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.

Inclusion Criteria

Exclusion Criteria

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial

A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults

A Clinical Trial of COVAC-2 in Adults

COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients