Covid19SIDIACO-RETRO'NCT04382794
Sitagliptin Treatment in Diabetic COVID-19 Positive Patients
An observational study of Covid19, run by University of Milan at 6 sites in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 338 participants
- Where
- 6 sitesItaly
- Study dates
- 14 May 2020to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The anonymous data of diabetic patients hospitalized for COVID19 in the hospitals participating in the study will be collected
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Papa Giovanni XXIII Hospital
Bergamo, 24127
Ospedale dell'Angelo, Venezia-Mestre
Mestre, 30174
ASST FBF-Sacco P.O. Sacco
Milan, MI, 20157
Humanitas Hospital
Milan, 20089
University of Pavia
Pavia, 20100
IRCCS Policlinico S. Matteo
Pavia, 27100
About this study
Official title: Sitagliptin Treatment in Diabetic COVID-19 Positive Patients: Retrospective Study
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.
Read the 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)
- Conditions
- Covid19
- Being tested
- Retrospective case-control analysis
- Keywords
- Covid19, Sitagliptin, Diabetes Mellitus, Type 2
- Medical subject headings
- COVID-19, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective case-control analysisDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Retrospective case-control analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameter of acute lung disease
Clinical evaluation of physiological parameter "cough" associated with acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Clinical parameter of acute lung disease
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
Measured: 1 month
Clinical parameter of acute lung disease
Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Clinical parameter of acute lung disease
Variation of the clinical parameter "PaO2/FiO2" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Clinical parameter of acute lung disease
Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Clinical parameter of acute lung disease
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
Measured: 1 month
Clinical parameter of acute lung disease
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
Measured: 1 month
Death
Death of the patient during hospitalization due to COVID19
Measured: 1 month
Secondary outcomes (7)
Biochemical parameter of acute lung disease
Variation of the biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Biochemical parameter of acute lung disease
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
Measured: 1 month
Biochemical parameter of acute lung disease
Variation of the biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Biochemical parameter of acute lung disease
Variation of the biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Biochemical parameter of acute lung disease
Variation of the biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Biochemical parameter of acute lung disease
Variation of the biochemical parameter "fasting blood glucose" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Clinical parameter of acute lung disease
Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start14 May 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital, Fondazione IRCCS Policlinico San Matteo di Pavia, Humanitas Hospital, Italy, Ospedale dell'Angelo, Venezia-Mestre, University of Pavia
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
- Investigators
- Paolo Fiorina, MD, PhD, Principal investigator, ASST FBF Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382794
- Sponsor's protocol ID
- 5/2020
- Acronym
- SIDIACO-RETRO'
- Status last verified
- Jul 2020
- First submitted
- 8 May 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.
PubMed 16759303Perlman S, Azhar EI, Memish ZA, Hui DS, Zumla A. Confronting the persisting threat of the Middle East respiratory syndrome to global health security. Lancet Infect Dis. 2020 Feb;20(2):158-160. doi: 10.1016/S1473-3099(19)30347-0. Epub 2019 Jul 3. No abstract available.
PubMed 31279728Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
PubMed 32178769Zou H, Zhu N, Li S. The emerging role of dipeptidyl-peptidase-4 as a therapeutic target in lung disease. Expert Opin Ther Targets. 2020 Feb;24(2):147-153. doi: 10.1080/14728222.2020.1721468. Epub 2020 Jan 31.
PubMed 31971463Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Meyerholz DK, Lambertz AM, McCray PB Jr. Dipeptidyl Peptidase 4 Distribution in the Human Respiratory Tract: Implications for the Middle East Respiratory Syndrome. Am J Pathol. 2016 Jan;186(1):78-86. doi: 10.1016/j.ajpath.2015.09.014. Epub 2015 Nov 18.
PubMed 26597880Lambeir AM, Durinx C, Scharpe S, De Meester I. Dipeptidyl-peptidase IV from bench to bedside: an update on structural properties, functions, and clinical aspects of the enzyme DPP IV. Crit Rev Clin Lab Sci. 2003 Jun;40(3):209-94. doi: 10.1080/713609354.
PubMed 12892317Schade J, Stephan M, Schmiedl A, Wagner L, Niestroj AJ, Demuth HU, Frerker N, Klemann C, Raber KA, Pabst R, von Horsten S. Regulation of expression and function of dipeptidyl peptidase 4 (DP4), DP8/9, and DP10 in allergic responses of the lung in rats. J Histochem Cytochem. 2008 Feb;56(2):147-55. doi: 10.1369/jhc.7A7319.2007. Epub 2007 Oct 29.
PubMed 17967935Bolla AM, Loretelli C, Montefusco L, Finzi G, Abdi R, Ben Nasr M, Lunati ME, Pastore I, Bonventre JV, Nebuloni M, Rusconi S, Santus P, Zuccotti G, Galli M, D'Addio F, Fiorina P. Inflammation and vascular dysfunction: The negative synergistic combination of diabetes and COVID-19. Diabetes Metab Res Rev. 2022 Oct;38(7):e3565. doi: 10.1002/dmrr.3565. Epub 2022 Jul 22.
PubMed 35830597
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Treatment in Diabetic COVID-19 Positive Patients: Retrospective Study
- ClinicalTrials.gov ID
- NCT04382794
- Acronym / sponsor ID
- SIDIACO-RETRO' / 5/2020
- Conditions
- Covid19
- Keywords
- Covid19, Sitagliptin, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital, Fondazione IRCCS Policlinico San Matteo di Pavia, Humanitas Hospital, Italy, Ospedale dell'Angelo, Venezia-Mestre, University of Pavia
- Study start
- 14 May 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMT2 COVID19 positive patients treated with Sitagliptin | – | Drug: Retrospective case-control analysisThe 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 |
| DMT2 COVID19 positive patients not treated with Sitagliptin | – | Drug: Retrospective case-control analysisThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The anonymous data of diabetic patients hospitalized for COVID19 in the hospitals participating in the study will be collected
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective case-control analysisEvaluation 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 | Drug | DMT2 COVID19 positive patients not treated with Sitagliptin, DMT2 COVID19 positive patients treated with Sitagliptin |
Primary outcome
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
7 secondary outcomes
Biochemical parameter of acute lung disease
Time frame: 1 month
Biochemical parameter of acute lung disease
Time frame: 1 month
Biochemical parameter of acute lung disease
Time frame: 1 month
Biochemical parameter of acute lung disease
Time frame: 1 month
Biochemical parameter of acute lung disease
Time frame: 1 month
Biochemical parameter of acute lung disease
Time frame: 1 month
Clinical parameter of acute lung disease
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 16759303Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.
- Background: PubMed 31279728Perlman S, Azhar EI, Memish ZA, Hui DS, Zumla A. Confronting the persisting threat of the Middle East respiratory syndrome to global health security. Lancet Infect Dis. 2020 Feb;20(2):158-160. doi: 10.1016/S1473-3099(19)30347-0. Epub 2019 Jul 3. No abstract available.
- Background: PubMed 32178769Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
- Background: PubMed 31971463Zou H, Zhu N, Li S. The emerging role of dipeptidyl-peptidase-4 as a therapeutic target in lung disease. Expert Opin Ther Targets. 2020 Feb;24(2):147-153. doi: 10.1080/14728222.2020.1721468. Epub 2020 Jan 31.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 26597880Meyerholz DK, Lambertz AM, McCray PB Jr. Dipeptidyl Peptidase 4 Distribution in the Human Respiratory Tract: Implications for the Middle East Respiratory Syndrome. Am J Pathol. 2016 Jan;186(1):78-86. doi: 10.1016/j.ajpath.2015.09.014. Epub 2015 Nov 18.
- Background: PubMed 12892317Lambeir AM, Durinx C, Scharpe S, De Meester I. Dipeptidyl-peptidase IV from bench to bedside: an update on structural properties, functions, and clinical aspects of the enzyme DPP IV. Crit Rev Clin Lab Sci. 2003 Jun;40(3):209-94. doi: 10.1080/713609354.
- Background: PubMed 17967935Schade J, Stephan M, Schmiedl A, Wagner L, Niestroj AJ, Demuth HU, Frerker N, Klemann C, Raber KA, Pabst R, von Horsten S. Regulation of expression and function of dipeptidyl peptidase 4 (DP4), DP8/9, and DP10 in allergic responses of the lung in rats. J Histochem Cytochem. 2008 Feb;56(2):147-55. doi: 10.1369/jhc.7A7319.2007. Epub 2007 Oct 29.
- Derived from this study: PubMed 35830597Bolla AM, Loretelli C, Montefusco L, Finzi G, Abdi R, Ben Nasr M, Lunati ME, Pastore I, Bonventre JV, Nebuloni M, Rusconi S, Santus P, Zuccotti G, Galli M, D'Addio F, Fiorina P. Inflammation and vascular dysfunction: The negative synergistic combination of diabetes and COVID-19. Diabetes Metab Res Rev. 2022 Oct;38(7):e3565. doi: 10.1002/dmrr.3565. Epub 2022 Jul 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Fiorina, MD, PhD principal investigator
ASST FBF Sacco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Milan at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical parameter of acute lung disease (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382794, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.