Type 2 DiabetesPhase 4NCT04535700
Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19
A Phase 4 study testing Pioglitazone 30 mg in people with Type 2 Diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pioglitazone 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2020to 10 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Patients requiring mechanical ventilation at the time of inclusion
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Pioglitazone 30 mg, standard of care
- Keywords
- pioglitazone, Covid19
- Medical subject headings
- Diabetes Mellitus, Type 2, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 30 mgDrug
Patients receive 30 mg/day of pioglitazone for the entire period they remain in hospital
standard of careOther
Patients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Experimental | Not described Receives: Drug: Pioglitazone 30 mg |
| Standard of care treatment | Other | Not described Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Proportion of patients who develop heart failure or adverse reaction associated with treatment.
Measured: Everyday through hospitalization period, an average of 10-20 days until hospital discharge
Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.
Changes in this inflammation parameter: C-reactive protein (in mg/dl)
Measured: 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.
Changes in this inflammation parameter: D-dimer (in μg/mL)
Measured: 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.
Changes in this inflammation parameter: ferritin (in ng/mL)
Measured: 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.
Changes in this inflammation parameter: creatine kinase (CK) (in mg/dL)
Measured: 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.
Changes in this inflammation parameter: number of lymphocytes (in μL)
Measured: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start18 Sep 2020
- Primary completion19 Nov 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535700
- Sponsor's protocol ID
- ESCORPIO
- Status last verified
- May 2023
- First submitted
- 27 Aug 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-blinded, Randomized and Controlled Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19
- ClinicalTrials.gov ID
- NCT04535700
- Acronym / sponsor ID
- ESCORPIO
- Conditions
- Type 2 Diabetes
- Keywords
- pioglitazone, Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pioglitazone | Experimental | Drug: Pioglitazone 30 mg |
| Standard of care treatment | Other | Other: standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 30 mgPatients receive 30 mg/day of pioglitazone for the entire period they remain in hospital | Drug | pioglitazone |
| standard of carePatients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized. | Other | Standard of care treatment |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone 30 mg in people with Type 2 Diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.