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Column | Value |
---|---|
Trial registration number | NCT04535700 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-09-02 |
Recruitment status
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
Completed |
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 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 |
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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. 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 |
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Nov. 19, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Spain |
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
8 |
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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. |
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 993, "treatment_name": "Pioglitazone", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |