Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. (DMMETCOV19-2)

Laboratorios Silanes

Status and phase: Completed; Phase 2

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Drug: Metformin Glycinate; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04625985

SIL-30000-II-20(2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Metformin glycinate

Experimental group

Description:

620 mg bid (PO) for 14 days plus standard treatment

Treatment:

Drug: Metformin Glycinate

Placebo

Placebo Comparator group

Description:

Placebo tablet bid (PO) for 14 days plus standard treatment

Treatment:

Drug: Placebo oral tablet