NCT04535700

Brief Summary

The treatment with pioglitazone added to the standard treatment of patients with DM2 hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a second phase of severe systemic inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

August 27, 2020

Last Update Submit

May 30, 2023

Conditions

Type 2 Diabetes

Keywords

pioglitazoneCovid19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection.

    Everyday through hospitalization period, an average of 10-20 days until hospital discharge

  • Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

    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.

    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.

    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.

    Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge

  • +1 more secondary outcomes

Study Arms (2)

pioglitazone

EXPERIMENTAL
Drug: Pioglitazone 30 mg

Standard of care treatment

OTHER
Other: standard of care

Interventions

Pioglitazone 30 mgDRUG

Patients receive 30 mg/day of pioglitazone for the entire period they remain in hospital

pioglitazone
standard of careOTHER

Patients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized.

Standard of care treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 18 years
  • Confirmed diagnosis of COVID-19 or high clinical suspicion according to current criteria.
  • Diagnosis prior to admission of DM2.
  • Patients who provide their informed consent to participate in the study

You may not qualify if:

  • Under 18 years
  • Known hypersensitivity to the active ingredient or any of the drug's excipients.
  • Known history of heart failure or situation at the time of initiation of the heart failure study.
  • Hepatic failure.
  • Dialysis
  • Situation of diabetic ketoacidosis at the start of the study.
  • Diabetes mellitus different from type 2.
  • Active bladder cancer or a history of bladder cancer
  • Hematuria
  • Patients included in another experimental study with another drug.
  • Admission to the Intensive Care Unit.
  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2COVID-19

Interventions

PioglitazoneStandard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 2, 2020

Study Start

September 18, 2020

Primary Completion

November 19, 2021

Study Completion

January 10, 2022

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

ES(1)