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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04371978
• Other study ID #: 0303-20-RMC
• Status: Terminated
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2021
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: May 4, 2021
• Est. primary completion date: April 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.

3. Confirmation of infection with SARS-CoV-2 by PCR testing.

4. Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).

Exclusion Criteria:

1. WHO COVID-19 Ordinal Scale for Clinical Improvement = 6.

2. Respiratory failure requiring mechanical ventilation prior to randomization.

3. Use of vasopressor or inotropic medications prior to randomization.

4. Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.

5. Patients expected to require intensive care unit admission or immediate surgical intervention.

6. Participation in another trial assessing any treatment for COVID-19.

7. Current treatment with a DPP-4 inhibitor.

8. Pregnancy.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID 19
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dipeptidyl-Peptidase IV Inhibitors
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Hormones
• Hypoglycemic Agents
• Incretins
• Linagliptin
• Metabolic Disease
• Metabolic Diseases
• Respiratory Tract Diseases
• Sars-CoV2
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Drug:
• Linagliptin 5 MG
Linagliptin 5 mg PO once daily

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Rabin Medical Center, Beilinson Campus	Petah tikva
Israel	Rabin Medical Center, Hasharon Campus	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of serious adverse events and premature discontinuation of treatment.		28 days
Secondary	Percent of patients with clinical improvement.	Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.	28 days
Secondary	Length of hospitalization.		28 days
Secondary	All-cause mortality.		28 days
Secondary	Percent of supplemental oxygen use.		28 days
Secondary	Supplemental oxygen-free days.		28 days
Secondary	Percent of mechanical ventilation use.		28 days
Secondary	Ventilator-free days.		28 days
Secondary	Percent of ICU admissions.		28 days
Secondary	ICU-free days.		28 days
Secondary	Percent of 50% decrease in C-reactive protein (CRP) levels		Up to 28 days
Secondary	Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.		28 days