Coronavirus, 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, Respiratory Tract Diseases, Sars-CoV2, Severe Acute Respiratory Syndrome Coronavirus 2
Conditions
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.
Interventions
DRUGLinagliptin 5 MG
Linagliptin 5 mg PO once daily
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical change | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients with clinical improvement. | 28 days | Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19. |
| Length of hospitalization. | 28 days | — |
| All-cause mortality. | 28 days | — |
| Percent of supplemental oxygen use. | 28 days | — |
| Supplemental oxygen-free days. | 28 days | — |
| Percent of serious adverse events and premature discontinuation of treatment. | 28 days | — |
| Ventilator-free days. | 28 days | — |
| Percent of ICU admissions. | 28 days | — |
| ICU-free days. | 28 days | — |
| Percent of 50% decrease in C-reactive protein (CRP) levels | Up to 28 days | — |
| Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test. | 28 days | — |
| Percent of mechanical ventilation use. | 28 days | — |
Countries
Israel
Outcome results
None listed