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

NCT04626089 | Withdrawn Phase 2

• 1 other identifier: SIL-30000-II(1)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; Metabolic Syndrome; Type 2 Diabetes

Keywords

SARS-CoV 2; Metabolic Syndrome; Type 2 diabetes; Severe Acute Respiratory Syndrome; Metformin glycinate

Outcome Measures

Primary Outcomes (1)

• Viral Load

  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 Outcomes (11)

• Days of supplementary oxygen if apply

  Day 0 to day 28 or patient discharge day

• Days of supplementary mechanical ventilation if apply

  Day 0 to day 28 or patient discharge day

• Days of Hospitalization

  Day 0 to day 28 or patients discharge day

• Normalization of fever

  Day 0 to day 28 or patient discharge day

• Normalization of oxigen saturation

  Day 0 to day 28 or patient discharge day

Study Arms (2)

Metformin glycinate

EXPERIMENTAL

620 mg bid (PO) plus standard treatment for 14 days

Drug: metformin glycinate

Placebo

PLACEBO COMPARATOR

Placebo tablets bid (PO) plus standard treatment for 14 days

Drug: Placebo oral tablet

Interventions

metformin glycinate DRUG

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

Also known as: DMMET

Metformin glycinate

Placebo oral tablet DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Ability to understand and the willingness to sign a written informed consent document before any study procedure
• Metabolic syndrome or type 2 diabetes
• Coronavirus infection, severe acute respiratory syndrome SARS-CoV- 2 confirmed by the Polymerase Chain Reaction test (PCR) ≤ 4 days before of the randomization.
• Hospitalized patient.
• Radiographic evidence of pulmonary infiltrates

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Hospital Juárez de México, OPD

Mexico City, 07760, Mexico

Location

Related Publications (48)

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MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Fausto González-Villagrán, MD

  Hospital Juárez de México, OPD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parallel assignment experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 12, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)