Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2 (DMMETCOV19)

April 5, 2021 updated by: Laboratorios Silanes S.A. de C.V.

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 07760
        • Hospital Juárez de México, OPD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. Metabolic syndrome or type 2 diabetes
  4. Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
  5. Hospitalized patient.
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • DMMET
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:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Load
Time Frame: 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
Day 0 to Day 8 or patient discharge day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of supplementary oxygen if apply
Time Frame: Day 0 to day 28 or patient discharge day
Assess length of supplementary oxygen
Day 0 to day 28 or patient discharge day
Days of supplementary mechanical ventilation if apply
Time Frame: Day 0 to day 28 or patient discharge day
Assess length of mechanical ventilation
Day 0 to day 28 or patient discharge day
Days of Hospitalization
Time Frame: Day 0 to day 28 or patients discharge day
Assess length of hospitalization
Day 0 to day 28 or patients discharge day
Normalization of fever
Time Frame: 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
Day 0 to day 28 or patient discharge day
Normalization of oxigen saturation
Time Frame: 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
Day 0 to day 28 or patient discharge day
Number of deaths
Time Frame: 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
Day 0 to day 28 or patient discharge day
Change in Serum creatinine levels
Time Frame: 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
Day 0 to day 28 or patients discharge day
Change in serum Troponin I
Time Frame: 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
Day 0 to day 28 or patients discharge day
Change in serum aspartate aminotransferase levels
Time Frame: 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
Day 0 to day 28 or patients discharge day
Change in serum Creatine kinase-MB levels
Time Frame: 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
Day 0 to day 28 or patients discharge day
Incidence of adverse event
Time Frame: Day 0 to day 28 or patients discharge day
Assess by incidence of grade 3, grade 4 and Serious adverse events
Day 0 to day 28 or patients discharge day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Fausto González-Villagrán, MD, Hospital Juárez de México, OPD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30000-II(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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