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

NCT ID: NCT04626089

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-02-28

Brief Summary

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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

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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

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Severe Acute Respiratory Syndrome Coronavirus 2 Metabolic Syndrome Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group: Metformin glycinate 620 mg bid (PO) plus standard treatment for 14 days. Control Group: Placebo bid (PO) plus standard treatment for 14 days plus
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Parallel assignment experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number

Study Groups

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Metformin glycinate

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

Group Type EXPERIMENTAL

metformin glycinate

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

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

Interventions

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metformin glycinate

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

Intervention Type DRUG

Placebo oral tablet

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

Intervention Type DRUG

Other Intervention Names

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DMMET Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fausto González-Villagrán, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juárez de México, OPD

Locations

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Hospital Juárez de México, OPD

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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Other Identifiers

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SIL-30000-II(1)

Identifier Type: -

Identifier Source: org_study_id

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