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Clinical Trial Details

Trial ID: L2943
Source ID: NCT04626089
Associated Drug: Metformin Glycinate
Title: Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
Acronym: DMMETCOV19
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2|Metabolic Syndrome|Type 2 Diabetes
Interventions: DRUG: metformin glycinate|DRUG: Placebo oral tablet
Outcome Measures: Primary: Viral Load, Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate, Day 0 to Day 8 or patient discharge day | Secondary: Days of supplementary oxygen if apply, Assess length of supplementary oxygen, Day 0 to day 28 or patient discharge day|Days of supplementary mechanical ventilation if apply, Assess length of mechanical ventilation, Day 0 to day 28 or patient discharge day|Days of Hospitalization, Assess length of hospitalization, Day 0 to day 28 or patients discharge day|Normalization of fever, Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate, Day 0 to day 28 or patient discharge day|Normalization of oxigen saturation, Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate, Day 0 to day 28 or patient discharge day|Number of deaths, Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate, Day 0 to day 28 or patient discharge day|Change in Serum creatinine levels, Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl, Day 0 to day 28 or patients discharge day|Change in serum Troponin I, Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l, Day 0 to day 28 or patients discharge day|Change in serum aspartate aminotransferase levels, Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l, Day 0 to day 28 or patients discharge day|Change in serum Creatine kinase-MB levels, Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l, Day 0 to day 28 or patients discharge day|Incidence of adverse event, Assess by incidence of grade 3, grade 4 and Serious adverse events, Day 0 to day 28 or patients discharge day
Sponsor/Collaborators: Sponsor: Laboratorios Silanes S.A. de C.V.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-02
Completion Date: 2021-02
Results First Posted:
Last Update Posted: 2021-04-08
Locations: Hospital Juárez de México, OPD, Mexico City, 07760, Mexico
URL: https://clinicaltrials.gov/show/NCT04626089