Study Stopped
End of COVID-19 outbreak in Israel
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
1 other identifier
interventional
64
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2020
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedJune 2, 2021
May 1, 2021
6 months
April 30, 2020
May 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time to clinical change
Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
28 days
Secondary Outcomes (12)
Percent of serious adverse events and premature discontinuation of treatment.
28 days
Percent of patients with clinical improvement.
28 days
Length of hospitalization.
28 days
All-cause mortality.
28 days
Percent of supplemental oxygen use.
28 days
- +7 more secondary outcomes
Study Arms (2)
DPP-4 inhibition
EXPERIMENTALParticipants in the Dipeptidyl Peptidase-4 (DPP-4) inhibition group will receive linagliptin in addition to standard of care insulin regimen as per hospital protocol during their entire hospitalization.
Control
NO INTERVENTIONParticipants in the control group will receive only the standard of care insulin regimen as per hospital protocol during their entire hospitalization.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.
- Confirmation of infection with SARS-CoV-2 by PCR testing.
- Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).
You may not qualify if:
- WHO COVID-19 Ordinal Scale for Clinical Improvement ≥ 6.
- Respiratory failure requiring mechanical ventilation prior to randomization.
- Use of vasopressor or inotropic medications prior to randomization.
- Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.
- Patients expected to require intensive care unit admission or immediate surgical intervention.
- Participation in another trial assessing any treatment for COVID-19.
- Current treatment with a DPP-4 inhibitor.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shamir Medical Center
Be’er Ya‘aqov, Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva, Israel
Rabin Medical Center, Hasharon Campus
Petah Tikva, Israel
Related Publications (1)
Abuhasira R, Ayalon-Dangur I, Zaslavsky N, Koren R, Keller M, Dicker D, Grossman A. A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Patients Hospitalized With Diabetes and COVID-19. Front Endocrinol (Lausanne). 2021 Dec 22;12:794382. doi: 10.3389/fendo.2021.794382. eCollection 2021.
PMID: 35002970DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Ran Abuhasira, Internal Medicine B
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 1, 2020
Study Start
October 1, 2020
Primary Completion
April 4, 2021
Study Completion
May 4, 2021
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share