COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04604223

Mohamed Abu-farha, PhD

mohamed.abufarha@dasmaninstitute.org

2020-10-27

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: t2dm according to the ada criteria. patients with long standing diabetes as well as patients with new onset diabetes will be recruited. patients receiving glucocorticoids for treatment of covid-19 and manifest plasma glucose levels consistent with diabetes diagnosis also will be included patients can be drug naïve, receiving oral antihyperglycemic therapy (except pioglitazone), glp-1 ra or insulin therapy will be allowed to participate in the study covid-19 infection confirmed with pcr test age 21-85 years patients of both sexes will be included in addition to diabetes and covid-19 diagnoses, patients should manifest at least one of covid-19 symptoms (fever, chills, headache, rhinorreah, cough (dry or with sputum), sore throat, shortness of breath, hemoptysis, altered mentation, fatigue/malaise, myalgia, nausea/vomiting, diarrhea, anosmia, chest pain). patient receiving other anti-inflammatory therapy for their routine covid-19 care (e.g. hydroxychloroquine), or antiviral therapy (e.g. remdesivire) will be included in the study and will be evenly randomized amongst the two treatment groups

t1dm absence of confirmation of covid-19 infection age <21 years presence of heart failure (lvef<40%) or a history of hospitalization for heart failure use of diuretics (furosemide or aldactone) for heart disease usually for heart failure. patients with hypertension receiving diuretic therapy (usually thiazide) will be included in the study patient on mechanical ventilation or patients whose clinical condition requires mechanical ventilation in the following 24 hours. patients not expected to survive > 48 hours patients receiving pioglitazone for the management of their diabetes patients participating in other research study will be excluded pregnant women will be excluded from the study

2

Dasman Diabetes Institute

21

85

Kuwait;Qatar

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1506

Difference in the incidence at 4 weeks of a composite outcome comprised of:;HsCRP level

None

Phase 4

[{"arm_notes": "", "treatment_id": 993, "treatment_name": "Pioglitazone", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]