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

NCT04625985 | Completed Phase 2

• 1 other identifier: SIL-30000-II-20(2)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

SARS-COV 2; Severe acute respiratory syndrome

Outcome Measures

Primary Outcomes (10)

• Viral load

  Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

  Day 0 to Day 28 or patient discharge day

• consciousness level

  Clinical status assessed by measurement of consciousness level: alertness

  Day 0 to Day 28 or patient discharge day

• temperature

  Clinical status assessed by measurement of axillary body temperature in °C: \<37.2.

  Day 0 to Day 28 or patient discharge day

• systolic blood pressure

  Clinical status assessed by measurement of systolic blood pressure in mmHg: \>90.

  Day 0 to Day 28 or patient discharge day

• Oxigen saturation

  Clinical status assessed by measurement of oxygen saturation in %: \>90.

  Day 0 to Day 28 or patient discharge day

• Heart rate

  Clinical status assessed by measurement of heart rate in beats per minute: \<100 bpm.

  Day 0 to Day 28 or patient discharge day

• respiratory rate

  Clinical status assessed by measurement of respiratory rate in breaths per minute: \<24 bpm,

  Day 0 to Day 28 or patient discharge day

• Days of hospitalization

  Assess length of hospitalization

  Day 0 to Day 28 or patient discharge day

• Days of supplementary oxygen if applies

  Assess length of supplementary oxygen

  Day 0 to Day 28 or patient discharge day

• Days of supplementary mechanical ventilation

  Assess length of mechanical ventilation

  Day 0 to Day 28 or patient discharge day

Secondary Outcomes (2)

• Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)

  Day 0 to Day 28 or patient discharge day

• Changes in laboratory test results

  Day 0 to Day 28 or patient discharge day

Study Arms (2)

Metformin glycinate

EXPERIMENTAL

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

Drug: Metformin Glycinate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Metformin Glycinate DRUG

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

Also known as: DMMET

Metformin glycinate

Placebo oral tablet DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Ability to understand and the willingness to sign a written informed consent document before any study procedure
• Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization.
• Hospitalized
• Radiographic evidence of pulmonary infiltrates

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Evidence of multi-organ failure
• Require mechanical ventilation before randomization
• Pregnant patients
• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

The American British Cowdray Medical Center, I.A.P

Mexico City, 01120, Mexico

Location

Related Publications (10)

• Fischer M, Timper K, Radimerski T, Dembinski K, Frey DM, Zulewski H, Keller U, Muller B, Christ-Crain M, Grisouard J. Metformin induces glucose uptake in human preadipocyte-derived adipocytes from various fat depots. Diabetes Obes Metab. 2010 Apr;12(4):356-9. doi: 10.1111/j.1463-1326.2009.01169.x.

  PMID: 20380657 BACKGROUND

• Cuthbertson J, Patterson S, O'Harte FP, Bell PM. Investigation of the effect of oral metformin on dipeptidylpeptidase-4 (DPP-4) activity in Type 2 diabetes. Diabet Med. 2009 Jun;26(6):649-54. doi: 10.1111/j.1464-5491.2009.02748.x.

  PMID: 19538242 BACKGROUND

• Musi N, Hirshman MF, Nygren J, Svanfeldt M, Bavenholm P, Rooyackers O, Zhou G, Williamson JM, Ljunqvist O, Efendic S, Moller DE, Thorell A, Goodyear LJ. Metformin increases AMP-activated protein kinase activity in skeletal muscle of subjects with type 2 diabetes. Diabetes. 2002 Jul;51(7):2074-81. doi: 10.2337/diabetes.51.7.2074.

  PMID: 12086935 RESULT

• Shaw RJ, Lamia KA, Vasquez D, Koo SH, Bardeesy N, Depinho RA, Montminy M, Cantley LC. The kinase LKB1 mediates glucose homeostasis in liver and therapeutic effects of metformin. Science. 2005 Dec 9;310(5754):1642-6. doi: 10.1126/science.1120781. Epub 2005 Nov 24.

  PMID: 16308421 RESULT

• Detaille D, Guigas B, Leverve X, Wiernsperger N, Devos P. Obligatory role of membrane events in the regulatory effect of metformin on the respiratory chain function. Biochem Pharmacol. 2002 Apr 1;63(7):1259-72. doi: 10.1016/s0006-2952(02)00858-4.

  PMID: 11960602 RESULT

• Tamura Y, Watada H, Sato F, Kumashiro N, Sakurai Y, Hirose T, Tanaka Y, Kawamori R. Effects of metformin on peripheral insulin sensitivity and intracellular lipid contents in muscle and liver of overweight Japanese subjects. Diabetes Obes Metab. 2008 Sep;10(9):733-8. doi: 10.1111/j.1463-1326.2007.00801.x. Epub 2007 Oct 15.

  PMID: 17941868 RESULT

• Standeven KF, Ariens RA, Whitaker P, Ashcroft AE, Weisel JW, Grant PJ. The effect of dimethylbiguanide on thrombin activity, FXIII activation, fibrin polymerization, and fibrin clot formation. Diabetes. 2002 Jan;51(1):189-97. doi: 10.2337/diabetes.51.1.189.

  PMID: 11756340 RESULT

• Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Duran C, Gonzalez-Canudas J. Effect of metformin glycinate on glycated hemoglobin A1C concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13.

  PMID: 22974412 RESULT

• 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)

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Janet Silvia M Aguirre, MD

  The American British Cowdray Medical Center. I.A.P.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parallel Assignment Experimental and placebo tablets will have same physical appearance and medicine box will be identified by kit number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 12, 2020
• Study Start: July 14, 2020
• Primary Completion: March 8, 2021
• Study Completion: March 18, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)