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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371978
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ran Abuhasira, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
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 Drug: Linagliptin 5 MG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: DPP-4 inhibition
Participants 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.
Drug: Linagliptin 5 MG
Linagliptin 5 mg PO once daily
Other Name: Trajenta

No Intervention: Control
Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during their entire hospitalization.



Primary Outcome Measures :
  1. Time to clinical change [ Time Frame: 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 Outcome Measures :
  1. Percent of serious adverse events and premature discontinuation of treatment. [ Time Frame: 28 days ]
  2. Percent of patients with clinical improvement. [ Time Frame: 28 days ]
    Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.

  3. Length of hospitalization. [ Time Frame: 28 days ]
  4. All-cause mortality. [ Time Frame: 28 days ]
  5. Percent of supplemental oxygen use. [ Time Frame: 28 days ]
  6. Supplemental oxygen-free days. [ Time Frame: 28 days ]
  7. Percent of mechanical ventilation use. [ Time Frame: 28 days ]
  8. Ventilator-free days. [ Time Frame: 28 days ]
  9. Percent of ICU admissions. [ Time Frame: 28 days ]
  10. ICU-free days. [ Time Frame: 28 days ]
  11. Percent of 50% decrease in C-reactive protein (CRP) levels [ Time Frame: Up to 28 days ]
  12. Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test. [ Time Frame: 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371978


Contacts
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Contact: Ran Abuhasira, MD +972-3-9376600 ranabu@post.bgu.ac.il
Contact: Alon Grossman, MD +972-3-9376601 along@clalit.org.il

Locations
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Israel
Rabin Medical Center
Petah tikva, Israel
Contact: Ran Abuhasira, MD       ranabu@post.bgu.ac.il   
Sponsors and Collaborators
Rabin Medical Center
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Responsible Party: Ran Abuhasira, Dr. Ran Abuhasira, Internal Medicine B, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04371978    
Other Study ID Numbers: 0303-20-RMC
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Respiratory Tract Diseases
Endocrine System Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action