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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625985
Recruitment Status : Completed
First Posted : November 12, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Metformin Glycinate Drug: Placebo oral tablet Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental: Metformin glycinate 620 mg bid (PO) for 14 days plus standard treatment Control group: placebo bid (PO) for 14 days plus standard treatment

Comparator: Placebo Placebo pill bid (PO) for 14 days plus standard treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Parallel Assignment Experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number.
Primary Purpose: Treatment
Official Title: Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb
Actual Study Start Date : July 14, 2020
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : March 18, 2021


Arm Intervention/treatment
Experimental: Metformin glycinate
620 mg bid (PO) for 14 days plus standard treatment
Drug: Metformin Glycinate
Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
Other Name: DMMET

Placebo Comparator: Placebo
Placebo tablet bid (PO) for 14 days plus standard treatment
Drug: Placebo oral tablet
Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
Other Name: Placebo




Primary Outcome Measures :
  1. Viral load [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

  2. consciousness level [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of consciousness level: alertness

  3. temperature [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of axillary body temperature in °C: <37.2.

  4. systolic blood pressure [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.

  5. Oxigen saturation [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of oxygen saturation in %: >90.

  6. Heart rate [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.

  7. respiratory rate [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,

  8. Days of hospitalization [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Assess length of hospitalization

  9. Days of supplementary oxygen if applies [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Assess length of supplementary oxygen

  10. Days of supplementary mechanical ventilation [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Assess length of mechanical ventilation


Secondary Outcome Measures :
  1. Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4) [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)

  2. Changes in laboratory test results [ Time Frame: Day 0 to Day 28 or patient discharge day ]
    Changes in serum levels from security laboratories compared to baseline levels and between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625985


Locations
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Mexico
The American British Cowdray Medical Center, I.A.P
Mexico City, Mexico, 01120
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
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Principal Investigator: Janet Silvia M Aguirre, MD The American British Cowdray Medical Center. I.A.P.
Publications of Results:
González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Durán C, González-Canudas J. Efficacy and Safety of Metformin Glycinate vs. Metformin Hydrochloride in Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Mellitus Patients (T2DM). Diabetes Technol Ther. 2012 Dec;14(12):1140-4. Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097
Jorge González Canudas, COMET GROUP Diabetes Efficacy and Safety of Metformin Glycinate vs. Metformin Hydrochloride in Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Mellitus Patients. Diabetes 2019 Jun; 68(Supplement 1)
Garza-Ocañas L, Tamez-de la O E, Iglesias-Chiesa J, Gonzalez Canudas J, Rivas-Ruiz R: Pharmacokinetics and gastrointestinal tolerability of DMMET 01 (glycinate of metformin): results of a prospective randomized trial in healthy volunteers [abstract]. Diabetes 2009;58(Suppl 1):A533

Other Publications:
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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04625985    
Other Study ID Numbers: SIL-30000-II-20(2)
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Silanes S.A. de C.V.:
SARS-COV 2
Severe acute respiratory syndrome
Additional relevant MeSH terms:
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Metformin
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hypoglycemic Agents
Physiological Effects of Drugs