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Effects of DPP4 Inhibition on COVID-19

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ClinicalTrials.gov Identifier: NCT04341935
Recruitment Status : Withdrawn (Logistical challenges amid COVID-19 pandemic and lack of financial support)
First Posted : April 10, 2020
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Gianluca Iacobellis, University of Miami

Tracking Information
First Submitted Date  ICMJE April 6, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date June 10, 2021
Estimated Study Start Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
Changes in Glucose Llevels [ Time Frame: Baseline, up to 2 weeks ]
Change in glucose control will be assessed via glucose levels obtained from blood serum samples
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
  • Changes in SpO2 levels [ Time Frame: Baseline, up to 2 weeks ]
    changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
  • Changes in Interleukin 6 (IL6) [ Time Frame: Baseline, up to 2 weeks ]
    Changes in IL 6 will be assessed from blood serum samples
  • Changes in chest structures [ Time Frame: Baseline, up to 2 weeks ]
    Changes in Chest radiography (X-ray)
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 Effects of DPP4 Inhibition on COVID-19
Official Title  ICMJE Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes
Brief Summary The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus Infection
  • Type 2 Diabetes
Intervention  ICMJE
  • Drug: Linagliptin
    5 mg Linagliptin administered by mouth once daily
    Other Name: Tradjenta
  • Drug: Insulin regimen
    Standard of care insulin regimen as per hospital protocol
Study Arms  ICMJE
  • Experimental: DPP4 group
    Participants in the Dipeptidyl Peptidase 4 (DPP4) group will receive Linagliptin in addition to standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days
    Intervention: Drug: Linagliptin
  • Active Comparator: Control group
    Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days
    Intervention: Drug: Insulin regimen
Publications *

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 7, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2020)
20
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines
  • Age ≥ 18
  • Confirmed COVID-19
  • Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea
  • Moderate COVID-19 is defined as > 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 <90% up to 5L Nasal Cannula (NC)
  • No additional signs or symptoms of severe COVID-19.

Exclusion Criteria:

  • Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines
  • History of Diabetic Ketoacidosis (DKA)
  • History of acute pancreatitis
  • Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2

Exclusion Criteria:

T1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR < 30 ml/min/1.73 m2

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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341935
Other Study ID Numbers  ICMJE 20200384
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gianluca Iacobellis, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gianluca Iacobellis, MD PhD University of Miami
PRS Account University of Miami
Verification Date June 2021

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