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Sitagliptin Treatment in Diabetic COVID-19 Positive Patients (SIDIACO-RETRO')

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ClinicalTrials.gov Identifier: NCT04382794
Recruitment Status : Completed
First Posted : May 11, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
Papa Giovanni XXIII Hospital
IRCCS Policlinico S. Matteo
Humanitas Hospital, Italy
Ospedale dell'Angelo, Venezia-Mestre
University of Pavia
Information provided by (Responsible Party):
Paolo Fiorina, MD, University of Milan

Tracking Information
First Submitted Date May 8, 2020
First Posted Date May 11, 2020
Last Update Posted Date July 9, 2020
Actual Study Start Date May 14, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2020)
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Clinical evaluation of physiological parameter "cough" associated with acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "PaO2/FiO2" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "need for ventilator support" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "duration in days of ventilator support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study
  • Death [ Time Frame: 1 month ]
    Death of the patient during hospitalization due to COVID19
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2020)
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of the study
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of the study
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of the study
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of the study
  • Biochemical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the biochemical parameter "fasting blood glucose" of acute lung disease from the beginning of the study to the end of the study
  • Clinical parameter of acute lung disease [ Time Frame: 1 month ]
    Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sitagliptin Treatment in Diabetic COVID-19 Positive Patients
Official Title Sitagliptin Treatment in Diabetic COVID-19 Positive Patients: Retrospective Study
Brief Summary Coronavirus Pathology is frequently associated with both diabetes mellitus and metabolic syndrome. In particular, results of observational studies and meta-analyzes configure diabetes as one of the main risk factors for the development of complications and unfavorable course of SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), the syndromes caused respectively by SARS- VOC coronavirus and MERS-COV coronavirus. The available data confirm this association also in the clinical picture of the infection supported by SARS-COV 2 (COVID-19). In the epidemic outbreak that erupted at the beginning of 2020 in the Lombardy Region, about two thirds of the patients who died from COVID-19 were affected by diabetes mellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airways that can be fed by a cytokine storm and result in severe respiratory failure (10% cases) and death (5%). At the moment, the mainly involved pathophysiological molecular mechanisms are not clearly defined. It has been hypothesized that the transmembrane glycoprotein type II CD26, known for the enzyme activity Dipeptilpeptidase 4 exerted by its extracellular domain, may play a fundamental role in this process. In addition, it is considerably expressed at the parenchyma and lung interstitium level and carries out both systemic and paracrine enzymatic activity, modulating the activity of various proinflammatory cytokines, growth factors and vasoactive peptides at the level of the deep respiratory tract. The pulmonary parenchyma and the interstitium express significantly the Dipeptilpeptidase 4 protein, which in the Middle East Respiratory Syndrome favors the entry of the virus into the cells, thus allowing the virus to replicate within the cells and thus spread throughout the cell inside the organism. Dipeptilpeptidase 4 regulates the function of bioactive peptides and above all of cytokines, vasoactive peptides and chemokines present at the level of the mesothelium, of the deep respiratory tract (alveolar epithelium and alveolar bronchus), of endothelial and immune cells triggering the inflammatory storm. In line with this evidence, it has been hypothesized that acute respiratory disease from Coronavirus may depend on the massive localization of Dipeptilpeptidase 4 in lung tissue. Furthermore, the involvement of Dipeptilpeptidase 4 in other chronic respiratory diseases has been demonstrated. Starting from these observations we hypothesized that the selective blockade of Dipeptilpeptidase 4 can favorably modulate the pulmonary inflammatory response in the subject affected by COVID-19. Among the drugs that selectively block Dipeptilpeptidase 4, the one with greater affinity precisely for Dipeptilpeptidase 4 is Sitagliptin.
Detailed Description

An observational, retrospective-case control, multi-center study is proposed to evaluate any effects of Sitagliptin on clinical, laboratory and instrumental parameters in the course of hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study. The evaluation will be performed by comparing the parameters of COVID-19 positive diabetic patients treated with Sitagliptin with those of a group of COVID-19 positive diabetic patients not treated with Sitagliptin. All diabetic subjects treated with Sitagliptin (100 mg / day, 50 mg / day or 25 mg / day) and all diabetic subjects not treated with Sitagliptin, eligible for inclusion / exclusion criteria, will be included in the analysis.

The clinical data of patients that will be collected anonymously during hospitalization will include: smoking habit, remote medical history aimed at assessing the presence of comorbidities (atrial fibrillation, heart failure, hypertension, arterial hypertension, chronic obstructive pulmonary disease, other lung disease, chronic renal failure, decay cognitive, Parkinson's disease, autoimmune diseases), pharmacological history (treatment introduced during hospitalization for COVID-19, respiratory failure or other complications; use of ACE-inhibitors, sartans, calcium channel blockers, diuretics, antiarrhythmics, beta blockers, anti-aggregants, anticoagulants, neuroleptics ). Anthropometric parameters including blood pressure measurement and BMI will also be collected.

For all patients, the following data will be collected at the baseline (first data available upon entry into the hospitalization regime) and upon discharge:

  • Clinical picture and symptoms (presence of cough, body temperature, respiratory rate, need for ventilatory support, duration of ventilatory support in days, duration of oxygen therapy in day, duration of hospitalization in Intensive Care Unit in days, total length of stay in days, blood gas parameters, PaO2 / FiO2 ratio, oxygen saturation by pulse oximeter)
  • Routine blood chemistry tests performed in hospitalization (e.g. glycemia, reactive protein C, blood count with formula, erythrocyte sedimentation rate, blood gas analysis, LDH, inflammation indices).
  • Instrumental exams (chest x-ray)
  • glycated hemoglobin
  • Serum creatinine and Estimated Glomerular Filtration Rate (estimated with CKD-EPI)
  • Presence of specific comorbidities for diabetes
  • Average daily blood sugar levels (from capillary blood)
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The anonymous data of diabetic patients hospitalized for COVID19 in the hospitals participating in the study will be collected
Condition Covid19
Intervention Drug: Retrospective case-control analysis
Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study
Study Groups/Cohorts
  • DMT2 COVID19 positive patients treated with Sitagliptin
    The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study. The data will be anonymous and not attributable to individual subjects
    Intervention: Drug: Retrospective case-control analysis
  • DMT2 COVID19 positive patients not treated with Sitagliptin
    The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes not treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study. The data will be anonymous and not attributable to individual subjects
    Intervention: Drug: Retrospective case-control analysis
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 Completed
Actual Enrollment
 (submitted: July 8, 2020)
338
Original Estimated Enrollment
 (submitted: May 8, 2020)
200
Actual Study Completion Date June 15, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes, according to ADA 2020 criteria
  • Diagnosis of COVID-19 (positive SARS-COV2 RNA buffer) with pneumonia, with or without an increase in inflammation indexes, with or without respiratory failure

Exclusion Criteria:

  • Pregnancy
  • Type 1 diabetes
  • Presence of other acute infections in place
  • Presence of serious diseases or conditions that make the patient unsuitable for the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04382794
Other Study ID Numbers 5/2020
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.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Paolo Fiorina, MD, University of Milan
Study Sponsor University of Milan
Collaborators
  • Papa Giovanni XXIII Hospital
  • IRCCS Policlinico S. Matteo
  • Humanitas Hospital, Italy
  • Ospedale dell'Angelo, Venezia-Mestre
  • University of Pavia
Investigators
Principal Investigator: Paolo Fiorina, MD, PhD ASST FBF Sacco
PRS Account University of Milan
Verification Date July 2020