Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19

May 30, 2023 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Non-blinded, Randomized and Controlled Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the latest studies, the evolution of the SARS-CoV-2 (COVID-19) infection shows two clinically different phases: The first phase of viral and clinical infection of viriasis (fever, myalgia, etc.) affects all patients and it is resolved in asymptomatic patients or with clinically moderate-mild affectations. However, towards the end of the first week of illness, a not inconsiderable number of patients progress towards a second phase of rapid and abrupt deterioration of their respiratory and cardiac function.

More and more data indicate an important role of overactivated macrophages, interleukin 6 (IL6) and an excessive inflammatory response in the genesis of this second phase of aggravation. Linking with this hypothesis, the adipose tissue densely infiltrated by macrophages is the source of one third of the body's IL6, its production being even greater in the fat of central disposition of male distribution. All of this could explain the worse prognosis observed in men, obese and with type 2 diabetes (DM2).

Regarding the possible effect of pioglitazone on the expression of ACE2, there is little literature, and less evidence, about the response of this receptor to treatment with pioglitazone, and what is more important, its effect on COVID-19 infection.

Two studies have analyzed the expression of this receptor after administration of pioglitazone in different murine models of liver and kidney disease. The conclusions of these studies were that the administration of pioglitazone in rats with hepatic steatosis increased the expression of ACE2. It is known that the increased expression of ACE2 facilitates the entry of SARS-CoV-2 into the cell, in animal models it has been seen that ACE2 protects against the development of respiratory distress syndrome and that severe cases of COVID-19 and SARS 2003 have been linked to the possible inhibition of ACE2 by the virus and the increase in angiotensin II.

In conclusion, it is a safe and proven drug in patients with DM2, cheap, with years of clinical experience. The use of pioglitazone added to the conventional treatment of patients at high risk, such as patients with COVID-19 and DM2, could be accompanied by a better evolution of the patients, avoiding or mitigating the inflammatory process that already occurs before its onset. seems to trigger the second accelerated phase of the disease.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Under 18 years
  2. Known hypersensitivity to the active ingredient or any of the drug's excipients.
  3. Known history of heart failure or situation at the time of initiation of the heart failure study.
  4. Hepatic failure.
  5. Dialysis
  6. Situation of diabetic ketoacidosis at the start of the study.
  7. Diabetes mellitus different from type 2.
  8. Active bladder cancer or a history of bladder cancer
  9. Hematuria
  10. Patients included in another experimental study with another drug.
  11. Admission to the Intensive Care Unit.
  12. Patients requiring mechanical ventilation at the time of inclusion
  13. Pregnancy
  14. Lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pioglitazone
Drug: Pioglitazone 30 mg
Patients receive 30 mg/day of pioglitazone for the entire period they remain in hospital
Other: Standard of care treatment
Other: standard of care
Patients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through hospitalization period, an average of 10-20 days until hospital discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection.
Time Frame: Everyday through hospitalization period, an average of 10-20 days until hospital discharge
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.
Time Frame: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
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.
Time Frame: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
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.
Time Frame: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
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.
Time Frame: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
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.
Time Frame: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCORPIO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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