Controlled trial on the usefulness of pioglitazone treatment in patients with type 2 diabetes mellitus and COVID-19.

Controlled, randomized, non-blind trial on the usefulness of pioglitazone treatment in patients with type 2 diabetes mellitus and COVID-19. - ESCORPIO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001929-31-ES

Enrollment

Registered

2020-07-22

Start date

2020-06-16

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 in patients with diabetes mellitus type 2

Interventions

Trade Name: Actos® 30 mg comprimidos Actos® 15 mg comprimidos Pharmaceutical Form: Tablet INN or Proposed INN: PIOGLITAZONE CAS Number: 111025-46-8 Current Sponsor code: Takeda Pharma A/S Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients >18 years old - Confirmed diagnosis of COVID-19 or high clinical suspicion according to current criteria. - Previous diagnosis of DM2. - Patients who provide their informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: - Patients under 18 years - Known hypersensitivity to the active substance or any of the excipients of the drug. - Known history of heart failure or situation at the time of initiation of the cardiac failure study. - Liver failure. - Dialysis - Situation of diabetic ketoacidosis at the time of the start of the study. - Diabetes mellitus other than type 2. - Active bladder cancer or a history of bladder cancer - Non-philated macroscopic hematuria - Patients included in another experimental study with another drug. - Entry into the Intensive Care Unit. - Patients with mechanical ventilation requirement at the time of inclusion. - Pregnancy - Breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: -To demonstrate that treatment with pioglitazone added to the standard treatment of the patient with DM2 hospitalized by COVID-19 results in a decrease in the number of patients evolving to a second phase of severe systemic inflammation, thus reducing the need for mechanical ventilation, ICU admission and/or death (compound target). -To assess the safety of pioglitazone therapy in patients with DM2 and symptomatic SARS-Cov-2 infection.;Secondary Objective: -To demonstrate a decrease in systemic inflammation parameters during administration of pioglitazone treatment;Primary end point(s): Outcome of the hospitalization (duration, discharge, need for mechanical ventilation, entry into UCI or Exitus). Safety: Rate of patients who develop heart failure or adverse reaction associated with the treatment;Timepoint(s) of evaluation of this end point: Every day during the hospitalization of the patient.	—

Measure

Time frame

Main Objective: -To demonstrate that treatment with pioglitazone added to the standard treatment of the patient with DM2 hospitalized by COVID-19 results in a decrease in the number of patients evolving to a second phase of severe systemic inflammation, thus reducing the need for mechanical ventilation, ICU admission and/or death (compound target). -To assess the safety of pioglitazone therapy in patients with DM2 and symptomatic SARS-Cov-2 infection.;Secondary Objective: -To demonstrate a decrease in systemic inflammation parameters during administration of pioglitazone treatment;Primary end point(s): Outcome of the hospitalization (duration, discharge, need for mechanical ventilation, entry into UCI or Exitus). Safety: Rate of patients who develop heart failure or adverse reaction associated with the treatment;Timepoint(s) of evaluation of this end point: Every day during the hospitalization of the patient.

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Secondary

Measure	Time frame
Secondary end point(s): Routine blood markers of systemic inflammation: C reactive protein, D dimer, ferritin, troponin, lymphocytes. IL6, IL10 and IL12 (in those patients done in routine practice);Timepoint(s) of evaluation of this end point: Every 48h during hospitalization.	—

Countries

Spain

Contacts

Public ContactAnabel Sánchez

Fundación Investigación Biomédica Hospital Ramón y Cajal

anabelsanchez.hrc@gmail.com+34913368825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026