Diabetes MellitusNCT04550403
Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
An observational study of Diabetes Mellitus and Covid19, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial summary
Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Covid19
- How many people
- 757 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2020to 31 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with and without diabetes, hospitalized for COVID-19 between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy
Who may be able to join
- admission with COVID-19 to the Internal Medicine Unit dedicated to COVID-19 (Macrounit 1), academic hospital in Parma (Italy) between February 23 to March 31 2020.
Who cannot join
- during hospitalization inter or intra-hospital transfer of inpatients
Trial locations and contacts
1 site in 1 country.
About this study
Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.
Read the detailed description
The epidemic of coronavirus disease-2019 (COVID-19), a disease caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus, rapidly spread worldwide and was declared a pandemic by the World Health Organization on 11 March 2020.
It is well known that people with diabetes have increased infection risk, especially for influenza and pneumonia. Moreover, diabetes was previously reported as a major risk factor for mortality in people infected with the H1N1 pandemic influenza and, more recently, with the Middle East respiratory syndrome-related coronavirus (MERS-CoV) . Epidemiological studies have quickly and consistently pointed out diabetes as one of the major comorbidities associated with COVID-19 and affecting its severity.
The prevalence of diabetes in patients with COVID-19 was first reported to range from 5% to 20%. Furthermore, the COVID-19-Associated Hospitalisation Surveillance Network (COVID-NET) reported a diabetes prevalence of 28.3% in hospitalised patients in the USA.
More importantly, all studies published so far have reported a two- to threefold higher prevalence of diabetes in patients in ICUs compared with those with less severe disease and an increased mortality in people with diabetes. A recent meta-analysis further demonstrated that diabetes was associated with a more than doubled risk for ICU admission and a more than tripled risk for death.
However, precise data regarding diabetes characteristics in hospitalised people with COVID-19 are still lacking. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This study aims to identify the clinical and biological features and potential interactions of diabetic therapies associated with disease severity and mortality risk in people hospitalised for COVID-19. Hospital medical records of inpatients, hospitalized between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy will be analysed.
- Conditions
- Diabetes Mellitus, Covid19
- Keywords
- diabetes, Covid-19, inhospital mortality, intensive care unit
- Medical subject headings
- Diabetes Mellitus, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
to assess risk of intensive care unit admission and/or death among COVID-19 inpatients
Measured: february 23 to march 31, 2020
Secondary outcomes (6)
prevalence of death among COVID-19 inpatients with and without diabetes
to compare risk of death among inpatients in presence or absence of diabetes
Measured: february 23 to march 31, 2020
prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes
to compare intensive care unit admission among inpatients in presence or absence of diabetes
Measured: february 23 to march 31, 2020
demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization
to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measured: february 23 to march 31, 2020
laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization
to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measured: february 23 to march 31, 2020
pharmacological therapies and death and/or intensive care unit admission during hospitalization
to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization
Measured: february 23 to march 31, 2020
number of days of hospitalization in patients with and without diabetes
to compare total length of hospitalization in patients with or without diabetes
Measured: february 23 to march 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start30 Jul 2020
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Bonadonna, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Riccardo Bonadonna, MD, PhD, Principal investigator, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550403
- Sponsor's protocol ID
- 27557
- Status last verified
- Feb 2022
- First submitted
- 10 Sep 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Memish ZA, Perlman S, Van Kerkhove MD, Zumla A. Middle East respiratory syndrome. Lancet. 2020 Mar 28;395(10229):1063-1077. doi: 10.1016/S0140-6736(19)33221-0. Epub 2020 Mar 4.
PubMed 32145185Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.
PubMed 18948167Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
PubMed 19333547Drucker DJ. Coronavirus Infections and Type 2 Diabetes-Shared Pathways with Therapeutic Implications. Endocr Rev. 2020 Jun 1;41(3):bnaa011. doi: 10.1210/endrev/bnaa011.
PubMed 32294179Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.
PubMed 32267833
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes
- ClinicalTrials.gov ID
- NCT04550403
- Acronym / sponsor ID
- 27557
- Conditions
- Diabetes Mellitus, Covid19
- Keywords
- diabetes, Covid-19, inhospital mortality, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Sep 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.
Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.
Detailed description
The epidemic of coronavirus disease-2019 (COVID-19), a disease caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus, rapidly spread worldwide and was declared a pandemic by the World Health Organization on 11 March 2020.
It is well known that people with diabetes have increased infection risk, especially for influenza and pneumonia. Moreover, diabetes was previously reported as a major risk factor for mortality in people infected with the H1N1 pandemic influenza and, more recently, with the Middle East respiratory syndrome-related coronavirus (MERS-CoV) . Epidemiological studies have quickly and consistently pointed out diabetes as one of the major comorbidities associated with COVID-19 and affecting its severity.
The prevalence of diabetes in patients with COVID-19 was first reported to range from 5% to 20%. Furthermore, the COVID-19-Associated Hospitalisation Surveillance Network (COVID-NET) reported a diabetes prevalence of 28.3% in hospitalised patients in the USA.
More importantly, all studies published so far have reported a two- to threefold higher prevalence of diabetes in patients in ICUs compared with those with less severe disease and an increased mortality in people with diabetes. A recent meta-analysis further demonstrated that diabetes was associated with a more than doubled risk for ICU admission and a more than tripled risk for death.
However, precise data regarding diabetes characteristics in hospitalised people with COVID-19 are still lacking. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This study aims to identify the clinical and biological features and potential interactions of diabetic therapies associated with disease severity and mortality risk in people hospitalised for COVID-19. Hospital medical records of inpatients, hospitalized between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with and without diabetes, hospitalized for COVID-19 between February 23 to March 31 2020, at the Internal Medicine Unit dedicated to COVID-19 in the Academic Hospital of Parma, Italy
Key inclusion criteria (1 listed)
- admission with COVID-19 to the Internal Medicine Unit dedicated to COVID-19 (Macrounit 1), academic hospital in Parma (Italy) between February 23 to March 31 2020.
Key exclusion criteria (1 listed)
- during hospitalization inter or intra-hospital transfer of inpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients
Time frame: february 23 to march 31, 2020
to assess risk of intensive care unit admission and/or death among COVID-19 inpatients
6 secondary outcomes
prevalence of death among COVID-19 inpatients with and without diabetes
Time frame: february 23 to march 31, 2020
prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes
Time frame: february 23 to march 31, 2020
demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization
Time frame: february 23 to march 31, 2020
laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization
Time frame: february 23 to march 31, 2020
pharmacological therapies and death and/or intensive care unit admission during hospitalization
Time frame: february 23 to march 31, 2020
number of days of hospitalization in patients with and without diabetes
Time frame: february 23 to march 31, 2020
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 17 Feb 2022.
- Background: PubMed 32145185Memish ZA, Perlman S, Van Kerkhove MD, Zumla A. Middle East respiratory syndrome. Lancet. 2020 Mar 28;395(10229):1063-1077. doi: 10.1016/S0140-6736(19)33221-0. Epub 2020 Mar 4.
- Background: PubMed 18948167Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.
- Background: PubMed 19333547Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
- Background: PubMed 32294179Drucker DJ. Coronavirus Infections and Type 2 Diabetes-Shared Pathways with Therapeutic Implications. Endocr Rev. 2020 Jun 1;41(3):bnaa011. doi: 10.1210/endrev/bnaa011.
- Background: PubMed 32267833Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.
- Individual participant dataSharing planned: Undecided
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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.
Riccardo Bonadonna, MD, PhD principal investigator
Azienda Ospedaliero-Universitaria di Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Covid19, run by Azienda Ospedaliero-Universitaria di Parma at 1 site 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 1 inclusion and 1 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients (time frame: february 23 to march 31, 2020). 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 NCT04550403, which also lists 5 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 17 Feb 2022.