Back to resultsMetformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2 (DMMETCOV19)
Primary Purpose
Severe Acute Respiratory Syndrome Coronavirus 2, Metabolic Syndrome, Type 2 Diabetes
Status
Withdrawn
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
metformin glycinate
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 focused on measuring SARS-CoV 2, Metabolic Syndrome, Type 2 diabetes, Severe Acute Respiratory Syndrome, Metformin glycinate
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
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
Sites / Locations
- Hospital Juárez de México, OPD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metformin glycinate
Placebo
Arm Description
620 mg bid (PO) plus standard treatment for 14 days
Placebo tablets bid (PO) plus standard treatment for 14 days
Outcomes
Primary Outcome Measures
Viral Load
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Secondary Outcome Measures
Days of supplementary oxygen if apply
Assess length of supplementary oxygen
Days of supplementary mechanical ventilation if apply
Assess length of mechanical ventilation
Days of Hospitalization
Assess length of hospitalization
Normalization of fever
Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Normalization of oxigen saturation
Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Number of deaths
Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Change in Serum creatinine levels
Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Change in serum Troponin I
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Change in serum aspartate aminotransferase levels
Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Change in serum Creatine kinase-MB levels
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Incidence of adverse event
Assess by incidence of grade 3, grade 4 and Serious adverse events
Full Information
NCT ID
NCT04626089
First Posted
October 23, 2020
Last Updated
April 5, 2021
Sponsor
Laboratorios Silanes S.A. de C.V.
1. Study Identification
Unique Protocol Identification Number
NCT04626089
Brief Title
Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
Acronym
DMMETCOV19
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative decision of the company
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Silanes S.A. de C.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Parallel assignment experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin glycinate
Arm Type
Experimental
Arm Description
620 mg bid (PO) plus standard treatment for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets bid (PO) plus standard treatment for 14 days
Intervention Type
Drug
Intervention Name(s)
metformin glycinate
Other Intervention Name(s)
DMMET
Intervention Description
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
Primary Outcome Measure Information:
Title
Viral Load
Description
Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Time Frame
Day 0 to Day 8 or patient discharge day
Secondary Outcome Measure Information:
Title
Days of supplementary oxygen if apply
Description
Assess length of supplementary oxygen
Time Frame
Day 0 to day 28 or patient discharge day
Title
Days of supplementary mechanical ventilation if apply
Description
Assess length of mechanical ventilation
Time Frame
Day 0 to day 28 or patient discharge day
Title
Days of Hospitalization
Description
Assess length of hospitalization
Time Frame
Day 0 to day 28 or patients discharge day
Title
Normalization of fever
Description
Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Time Frame
Day 0 to day 28 or patient discharge day
Title
Normalization of oxigen saturation
Description
Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Time Frame
Day 0 to day 28 or patient discharge day
Title
Number of deaths
Description
Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Time Frame
Day 0 to day 28 or patient discharge day
Title
Change in Serum creatinine levels
Description
Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Time Frame
Day 0 to day 28 or patients discharge day
Title
Change in serum Troponin I
Description
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Time Frame
Day 0 to day 28 or patients discharge day
Title
Change in serum aspartate aminotransferase levels
Description
Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Time Frame
Day 0 to day 28 or patients discharge day
Title
Change in serum Creatine kinase-MB levels
Description
Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Time Frame
Day 0 to day 28 or patients discharge day
Title
Incidence of adverse event
Description
Assess by incidence of grade 3, grade 4 and Serious adverse events
Time Frame
Day 0 to day 28 or patients discharge day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto González-Villagrán, MD
Organizational Affiliation
Hospital Juárez de México, OPD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Juárez de México, OPD
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
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