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

Type 2 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04626089
• Other study ID #: SIL-30000-II(1)
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2021
• Est. completion date: February 2021

Study information

• Verified date: November 2020
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Syndrome
• Type 2 Diabetes

Intervention

Drug:
• metformin glycinate
Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
• Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days

Locations

Country	Name	City	State
Mexico	Hospital Juárez de México, OPD	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days of supplementary oxygen if apply	Assess length of supplementary oxygen	Day 0 to day 28 or patient discharge day
Secondary	Days of supplementary mechanical ventilation if apply	Assess length of mechanical ventilation	Day 0 to day 28 or patient discharge day
Secondary	Days of Hospitalization	Assess length of hospitalization	Day 0 to day 28 or patients discharge day
Secondary	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	Day 0 to day 28 or patient discharge day
Secondary	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	Day 0 to day 28 or patient discharge day
Secondary	Number of deaths	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
Secondary	Change in Serum creatinine levels	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
Secondary	Change in serum Troponin I	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
Secondary	Change in serum aspartate aminotransferase levels	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
Secondary	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	Day 0 to day 28 or patients discharge day
Secondary	Incidence of adverse event	Assess by incidence of grade 3, grade 4 and Serious adverse events	Day 0 to day 28 or patients discharge day