Clinical trial NCT04626089: Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
Official title: Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Metabolic Syndrome
Type 2 Diabetes
Keywords: SARS-CoV 2
Metabolic Syndrome
Type 2 diabetes
Severe Acute Respiratory Syndrome
Metformin glycinate
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Viral Load
timeFrame: Day 0 to Day 8 or patient discharge day
Secondary outcomes:
measure: Days of supplementary oxygen if apply
timeFrame: Day 0 to day 28 or patient discharge day
measure: Days of supplementary mechanical ventilation if apply
timeFrame: Day 0 to day 28 or patient discharge day
measure: Days of Hospitalization
timeFrame: Day 0 to day 28 or patients discharge day
measure: Normalization of fever
timeFrame: Day 0 to day 28 or patient discharge day
measure: Normalization of oxigen saturation
timeFrame: Day 0 to day 28 or patient discharge day
measure: Number of deaths
timeFrame: Day 0 to day 28 or patient discharge day
measure: Change in Serum creatinine levels
timeFrame: Day 0 to day 28 or patients discharge day
measure: Change in serum Troponin I
timeFrame: Day 0 to day 28 or patients discharge day
measure: Change in serum aspartate aminotransferase levels
timeFrame: Day 0 to day 28 or patients discharge day
measure: Change in serum Creatine kinase-MB levels
timeFrame: Day 0 to day 28 or patients discharge day
measure: Incidence of adverse event
timeFrame: Day 0 to day 28 or patients discharge day
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Juárez de México, OPD
Study officials:
affiliation: Hospital Juárez de México, OPD
name: Fausto González-Villagrán, MD
role: PRINCIPAL_INVESTIGATOR
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