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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Linagliptin 5 mg PO once daily
Shamir Medical Center
Be’er Ya‘aqov, Israel
Rabin Medical Center, Beilinson Campus
Petah Tikva, Israel
Rabin Medical Center, Hasharon Campus
Petah Tikva, Israel
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.
Time frame: 28 days
Percent of serious adverse events and premature discontinuation of treatment.
Time frame: 28 days
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.
Time frame: 28 days
Length of hospitalization.
Time frame: 28 days
All-cause mortality.
Time frame: 28 days
Percent of supplemental oxygen use.
Time frame: 28 days
Supplemental oxygen-free days.
Time frame: 28 days
Percent of mechanical ventilation use.
Time frame: 28 days
Ventilator-free days.
Time frame: 28 days
Percent of ICU admissions.
Time frame: 28 days
ICU-free days.
Time frame: 28 days
Percent of 50% decrease in C-reactive protein (CRP) levels
Time frame: Up to 28 days
Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.
Time frame: 28 days
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