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Clinical Trial Details

Trial ID: L5741
Source ID: NCT04535700
Associated Drug: Pioglitazone 30 Mg
Title: Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Pioglitazone 30 mg|OTHER: standard of care
Outcome Measures: Primary: Patients treated with pioglitazone, together with conventional treatment for COVID-19 infection, who during their admission evolve towards the need to receive support with mechanical ventilation, enter the ICU and / or die., Number of patients receive pioglitazone treatment during their hospital stay who receive support with mechanical ventilation, enter the ICU and / or die., Through hospitalization period, an average of 10-20 days until hospital discharge | Secondary: Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection., Proportion of patients who develop heart failure or adverse reaction associated with treatment., Everyday through hospitalization period, an average of 10-20 days until hospital discharge|Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment., Changes in this inflammation parameter: C-reactive protein (in mg/dl), Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge|Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment., Changes in this inflammation parameter: D-dimer (in μg/mL), Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge|Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment., Changes in this inflammation parameter: ferritin (in ng/mL), Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge|Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment., Changes in this inflammation parameter: creatine kinase (CK) (in mg/dL), Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge|Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment., Changes in this inflammation parameter: number of lymphocytes (in μL), Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
Sponsor/Collaborators: Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-18
Completion Date: 2022-01-10
Results First Posted:
Last Update Posted: 2023-05-31
Locations: Hospital Ramón y Cajal, Madrid, 28034, Spain
URL: https://clinicaltrials.gov/show/NCT04535700