drugset / Trial / NCT04371978

Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

NCT04371978 ↗

Phase 3 Terminated 64 enrolled Rabin Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.

Timeline

Start
2020-10-01
Primary completion
2021-04-04
Completion
2021-05-04

Outcome

Missed primary endpoint

Stopped: “End of COVID-19 outbreak in Israel”

paper there was no difference in the time to clinical improvement compared with the standard of care. PMID 35002970 ↗

paper hazard ratio, 1.22; 95% CI, 0.70-2.15; p = 0.49 PMID 35002970 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Linagliptin Unknown 5 mg Oral