Clinical trial
Non-blinded, Randomized and Controlled Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19
Name
ESCORPIO
Description
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 arms
Trial start
2020-09-18
Estimated PCD
2021-11-19
Trial end
2022-01-10
Status
Completed
Phase
Early phase I
Treatment
Pioglitazone 30 mg
Patients receive 30 mg/day of pioglitazone for the entire period they remain in hospital
Arms:
pioglitazone
standard of care
Patients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized.
Arms:
Standard of care treatment
Size
8
Primary endpoint
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.
Through hospitalization period, an average of 10-20 days until hospital discharge
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2023-05-31
1 organization
1 product
1 indication
Product
PioglitazoneIndication
Type 2 Diabetes