Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. (DMMETCOV19-2)

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

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, 01120
        • The American British Cowdray Medical Center, I.A.P

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. 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

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) for 14 days plus standard treatment
Drug: Metformin Glycinate
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
Other Names:
  • DMMET
Placebo Comparator: Placebo
Placebo tablet bid (PO) for 14 days plus standard treatment
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
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 28 or patient discharge day
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
Time Frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of consciousness level: alertness
Day 0 to Day 28 or patient discharge day
temperature
Time Frame: Day 0 to Day 28 or patient discharge day
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
Time Frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Day 0 to Day 28 or patient discharge day
Oxigen saturation
Time Frame: Day 0 to Day 28 or patient discharge day
Clinical status assessed by measurement of oxygen saturation in %: >90.
Day 0 to Day 28 or patient discharge day
Heart rate
Time Frame: Day 0 to Day 28 or patient discharge day
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
Time Frame: Day 0 to Day 28 or patient discharge day
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
Time Frame: Day 0 to Day 28 or patient discharge day
Assess length of hospitalization
Day 0 to Day 28 or patient discharge day
Days of supplementary oxygen if applies
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)
Time Frame: Day 0 to Day 28 or patient discharge day
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
Time Frame: Day 0 to Day 28 or patient discharge day
Changes in serum levels from security laboratories compared to baseline levels and between groups.
Day 0 to Day 28 or patient 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: Janet Silvia M Aguirre, MD, The American British Cowdray Medical Center. I.A.P.

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 (Actual)

July 14, 2020

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 18, 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

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30000-II-20(2)

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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