NCT04626089

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

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.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	metformin glycinate	Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
DRUG	Placebo oral tablet	Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-11-12
• Last updated: 2021-04-08

Locations

1 site across 1 country: Mexico