| Trial ID: | L4637 |
| Source ID: | NCT04604223
|
| Associated Drug: |
Pioglitazone 45 Mg
|
| Title: |
Effect of Pioglitazone on T2DM Patients With COVID-19
|
| Acronym: |
PIOQ8
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Covid19|Type 2 Diabetes
|
| Interventions: |
DRUG: Pioglitazone 45 mg
|
| Outcome Measures: |
Primary: HsCRP level, Difference from baseline to 4 weeks in inflammatory response between subjects receiving pioglitazone versus placebo measured as plasma hsCRP level., 4 weeks|Difference in the incidence at 4 weeks of a composite outcome comprised of:, 1) requirement for mechanical ventilation (invasive \[with tracheal tube\] or non-invasive); 2) myocardial damage measured as plasma troponin I level \> 3 times the upper normal limit; or 3) death., 4 weeks | Secondary: Number of days free of mechanical ventilation, 4 weeks|Number of days in the ICU, 4 weeks|Duration of hospitalization, 4 weeks|Change from baseline in qSOFA score, 4 Weeks|Change from baseline in SO2/FiO2, 4 Weeks|Difference in respiratory rate, Difference in respiratory rate, measured as the area under the curve of respiratory rate over time from baseline to week 4, 4 weeks|Incidence at 4 weeks of a composite of extrapulmonary disease comprised of :, (a) myocardial disease measured as troponin I above the normal limit at any time during hospitalization, (b) neurologic disease manifested as TIA, or symptoms of peripheral or central neurologic deficient at anytime during hospitalization, (c) renal failure measured as \> 50% decrease in eGFR, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Dasman Diabetes Institute | Collaborators: Ministry of Health, Kuwait|Texas Diabetes Institute|Kuwait University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1506
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-01-18
|
| Completion Date: |
2021-06-29
|
| Results First Posted: |
|
| Last Update Posted: |
2021-03-17
|
| Locations: |
Al-Amiri Hospital, Kuwait City, (Pick From List), 40000, Kuwait|Jaber Al Ahmad Al Sabah Hospital, Kuwait City, (Pick From List), 40000, Kuwait|Mishrif Field Hospital, Kuwait City, (Pick From List), 40000, Kuwait|Mubarak Al-Kabeer Hospital, Kuwait City, (Pick From List), 40000, Kuwait|Hamad Medical Corporation, Doha, Qatar
|
| URL: |
https://clinicaltrials.gov/show/NCT04604223
|
