Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2 (DMMETCOV19)

Laboratorios Silanes

Status and phase: Withdrawn; Phase 2

Conditions: Type 2 Diabetes; Severe Acute Respiratory Syndrome Coronavirus 2; Metabolic Syndrome

Treatments: Drug: metformin glycinate; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04626089

SIL-30000-II(1)

Details and patient eligibility

About

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.

Full 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.

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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Metformin glycinate

Experimental group

Description:

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

Treatment:

Drug: metformin glycinate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet