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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371978
Recruitment Status : Terminated (End of COVID-19 outbreak in Israel)
First Posted : May 1, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ran Abuhasira, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 1, 2020
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE October 1, 2020
Actual Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Percent of serious adverse events and premature discontinuation of treatment. [ Time Frame: 28 days ]
  • 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Official Title  ICMJE Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Linagliptin 5 MG
Linagliptin 5 mg PO once daily
Other Name: Trajenta
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Linagliptin 5 MG
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 28, 2021)
64
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2020)
100
Actual Study Completion Date  ICMJE May 4, 2021
Actual Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04371978
Other Study ID Numbers  ICMJE 0303-20-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ran Abuhasira, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP