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

Laboratorios Silanes S.A. de C.V.20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Metformin GlycinateDRUG

Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment

Placebo oral tabletDRUG

Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization. 4. Hospitalized 5. 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 5. Patients with kidney failure, cancer and among other conditions that due to their treatment and / or baseline condition, affect the distribution, bioavailability and elimination of the studied drug

Locations (1)

The American British Cowdray Medical Center, I.A.P

Mexico City, Mexico

Outcomes

Primary Outcomes

Viral load

Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate