| Trial ID: | L6697 |
| Source ID: | NCT04371978
|
| Associated Drug: |
Linagliptin 5 Mg
|
| Title: |
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
COVID 19|Coronavirus|Diabetes Mellitus, Type 2|Diabetes Mellitus|Glucose Metabolism Disorders|Metabolic Disease|Endocrine System Diseases|Dipeptidyl-Peptidase IV Inhibitors|Linagliptin|Severe Acute Respiratory Syndrome Coronavirus 2|Sars-CoV2|Hypoglycemic Agents|Respiratory Tract Diseases|Incretins|Hormones
|
| Interventions: |
DRUG: Linagliptin 5 MG
|
| Outcome Measures: |
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|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|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 mechanical ventilation use., 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
|
| Sponsor/Collaborators: |
Sponsor: Rabin Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10-01
|
| Completion Date: |
2021-05-04
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-02
|
| Locations: |
Shamir Medical Center, Be'er Ya'aqov, Israel|Rabin Medical Center, Beilinson Campus, Petah tikva, Israel|Rabin Medical Center, Hasharon Campus, Petah tikva, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT04371978
|
