Effect of Pioglitazone on T2DM Patients With COVID-19
Status:
Recruiting
Trial end date:
2021-06-29
Target enrollment:
Participant gender:
Summary
Approximately 10-15% of patients infected with COVID-19 develop severe illness characterized
by respiratory distress, increased risk of clotting disease, myocardial damage, stroke and
mortality. Subjects with Type 2 diabetes (T2DM) are at increased risk for severe COVID-19
disease. Exuberant inflammatory and immune responses were suggested as the etiology
responsible for the development of severe COVID-19 disease. The increased chronic
inflammatory state characteristic of T2DM could contribute to the increased risk of severe
COVID-19 disease in T2DM patients. Therefore, its possible that anti-inflammatory therapy
will reduce the risk of severe COVID-19 disease. Consistent with this assumption, a recent
study has reported that steroid therapy improves the outcome in patients with severe COVID-19
disease.
The medication pioglitazone is a strong insulin sensitizer that reduces plasma glucose
concentrations in T2DM patients. In addition to improving insulin sensitivity, several
studies have demonstrated that pioglitazone reduces chronic inflammation in T2DM patients,
which is manifested in a decrease in TNF-alpha, interleukin, hs CRP, leptin and other
inflammatory markers in T2DM treated with pioglitazone. Further, pioglitazone enhances the
plasma level of anti-inflammatory agents. For example, the plasma level of 15-epi-lipoxin A,
a lipid mediator with strong anti-inflammatory and inflammation-resolving effects that has
been reported to neutralize RNA coated viruses, is significantly elevated by pioglitazone
treatment in T2DM patients. Therefore, we hypothesize that administering pioglitazone to T2DM
patients who have moderate-to-severe COVID-19 will improve the clinical outcome of their
COVID-19 disease.
Phase:
Phase 4
Details
Lead Sponsor:
Dasman Diabetes Institute
Collaborators:
Kuwait University Ministry of Health, Kuwait Texas Diabetes Institute