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

NCT ID: NCT04535700

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2022-01-10

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.

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pioglitazone

Group Type: EXPERIMENTAL

Pioglitazone 30 mg

Intervention Type: DRUG

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

Standard of care treatment

Group Type: OTHER

standard of care

Intervention Type: OTHER

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

Interventions

Pioglitazone 30 mg

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

Intervention Type: DRUG

standard of care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Ramón y Cajal

Madrid, , Spain

Countries

Spain

Other Identifiers

ESCORPIO

Identifier Type: -

Identifier Source: org_study_id