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

• Sponsor: Laboratorios Silanes S.A. de C.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04625985
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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 treatmentExperimental: 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: Jul 14, 2020
• Actual Primary Completion Date: Mar 8, 2021
• Actual Study Completion Date: Mar 18, 2021

Arms and Interventions

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 Names: 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 Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Viral load [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 [Day 0 to Day 28 or patient discharge day]

   Clinical status assessed by measurement of consciousness level: alertness

3. temperature [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 [Day 0 to Day 28 or patient discharge day]

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

5. Oxigen saturation [Day 0 to Day 28 or patient discharge day]

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

6. Heart rate [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 [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 [Day 0 to Day 28 or patient discharge day]

   Assess length of hospitalization

9. Days of supplementary oxygen if applies [Day 0 to Day 28 or patient discharge day]

   Assess length of supplementary oxygen

10. Days of supplementary mechanical ventilation [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) [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 [Day 0 to Day 28 or patient discharge day]

   Changes in serum levels from security laboratories compared to baseline levels and between groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The American British Cowdray Medical Center, I.A.P	Mexico City		Mexico	01120

Sponsors and Collaborators

• Laboratorios Silanes S.A. de C.V.

Investigators

• Principal Investigator: Janet Silvia M Aguirre, MD, The American British Cowdray Medical Center. I.A.P.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Fischer M, Timper K, Radimerski T, Dembinski K, Frey DM, Zulewski H, Keller U, Müller 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.

• Responsible Party: Laboratorios Silanes S.A. de C.V.
• ClinicalTrials.gov Identifier: NCT04625985
• Other Study ID Numbers: SIL-30000-II-20(2)
• First Posted: Nov 12, 2020
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Severe Acute Respiratory Syndrome; Syndrome; Metformin

Study Results

No Results Posted as of Apr 8, 2021