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

Phase 2

Withdrawn

• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2; Metabolic Syndrome; Type 2 Diabetes
• Interventions: Drug: metformin glycinate; Drug: Placebo oral tablet

• Registration Number: NCT04626089
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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.

Study Timeline

• Study First Submitted: 2020-10-23
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-12
• Study Start: 2021-02
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin glycinate	metformin glycinate	620 mg bid (PO) plus standard treatment for 14 days
Placebo	Placebo oral tablet	Placebo tablets bid (PO) plus standard treatment for 14 days

Primary Outcome Measures

Name	Time	Method
Viral Load	Day 0 to Day 8 or patient discharge day	Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

Secondary Outcome Measures

Name	Time	Method
Normalization of oxigen saturation	Day 0 to day 28 or patient discharge day	Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Change in serum Creatine kinase-MB levels	Day 0 to day 28 or patients discharge day	Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Days of Hospitalization	Day 0 to day 28 or patients discharge day	Assess length of hospitalization
Days of supplementary mechanical ventilation if apply	Day 0 to day 28 or patient discharge day	Assess length of mechanical ventilation
Normalization of fever	Day 0 to day 28 or patient discharge day	Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Number of deaths	Day 0 to day 28 or patient discharge day	Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Change in serum Troponin I	Day 0 to day 28 or patients discharge day	Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Change in Serum creatinine levels	Day 0 to day 28 or patients discharge day	Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Days of supplementary oxygen if apply	Day 0 to day 28 or patient discharge day	Assess length of supplementary oxygen
Change in serum aspartate aminotransferase levels	Day 0 to day 28 or patients discharge day	Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Incidence of adverse event	Day 0 to day 28 or patients discharge day	Assess by incidence of grade 3, grade 4 and Serious adverse events

Trial Locations

Locations (1)

Hospital Juárez de México, OPD; 🇲🇽 Mexico City, Mexico