NCT04625985

Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.

Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (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 the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1 day screening period to determine eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind manner (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 for 14 days.

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

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

Timeline

• Start date: 2020-07-14
• Primary completion: 2021-03-08
• Completion: 2021-03-18
• First posted: 2020-11-12
• Last updated: 2021-04-08

Locations

1 site across 1 country: Mexico