Skip to main content
OpenTrials
Completed

NCT Number: NCT04625985

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Mexico City, 01120, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Glycinate

Drug

Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment

Other names: DMMET

Placebo oral tablet

Drug

Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment

Other names: Placebo

Primary outcomes

  1. 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

  2. consciousness level

    Time frame: Day 0 to Day 28 or patient discharge day

    Clinical status assessed by measurement of consciousness level: alertness

  3. 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.

  4. 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.

  5. Oxigen saturation

    Time frame: Day 0 to Day 28 or patient discharge day

    Clinical status assessed by measurement of oxygen saturation in %: >90.

  6. 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.

  7. 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,

  8. Days of hospitalization

    Time frame: Day 0 to Day 28 or patient discharge day

    Assess length of hospitalization

  9. Days of supplementary oxygen if applies

    Time frame: Day 0 to Day 28 or patient discharge day

    Assess length of supplementary oxygen

  10. Days of supplementary mechanical ventilation

    Time frame: Day 0 to Day 28 or patient discharge day

    Assess length of mechanical ventilation

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

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

Acronym: DMMETCOV19-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.