PancreatitisNCT05601258
Lipase Levels and Coronavirus Disease 2019
An observational study of Pancreatitis and Lipase Increased, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatitis, Lipase Increased
- What is being tested?
- Age, gender, hospitalization and mortality rates will be compared
- How many people
- 4,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2020to 9 Jul 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
- Child, Adult, Older adult
Study population: Eighteen years of age or older, whose lipase level is measured in the course of COVID 19, will be included in the study.
Who may be able to join
- Patients with lipase levels measured during COVID-19
Who cannot join
- Patients with age <18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Pancreatic Lipase Levels and Coronavirus Disease 2019
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.
In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.
- Conditions
- Pancreatitis, Lipase Increased
- Being tested
- Age, gender, hospitalization and mortality rates will be compared
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age, gender, hospitalization and mortality rates will be comparedOther
Age, gender, hospitalization and mortality rates will be compared
| Study group | Role | What they receive |
|---|---|---|
| patients with higher lipase level | patients with higher lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection Receives: Other: Age, gender, hospitalization and mortality rates will be compared | |
| Control | patients with normal lipase levels in the course of SARS-CoV-2 infection Receives: Other: Age, gender, hospitalization and mortality rates will be compared |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of lipase enzyme elevation will be compared
Measured: From 31th March 2020 until 9th July 2021
The mortaliy rate will be compared
Measured: From 31th March 2020 until 9th July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start31 Mar 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cevdet Duran, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601258
- Sponsor's protocol ID
- UsakUCevdet3
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pancreatic Lipase Levels and Coronavirus Disease 2019
- ClinicalTrials.gov ID
- NCT05601258
- Acronym / sponsor ID
- UsakUCevdet3
- Conditions
- Pancreatitis, Lipase Increased
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 1 Nov 2022 (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.
Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.
In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury and acute pancreatitis in the course of COVID 19 disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with higher lipase level | – | Other: Age, gender, hospitalization and mortality rates will be comparedpatients with higher lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection |
| Control | – | Other: Age, gender, hospitalization and mortality rates will be comparedpatients with normal lipase levels in the course of SARS-CoV-2 infection |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Eighteen years of age or older, whose lipase level is measured in the course of COVID 19, will be included in the study.
Key inclusion criteria (1 listed)
- Patients with lipase levels measured during COVID-19
Key exclusion criteria (1 listed)
- Patients with age <18 years Patients with pregnancy Patients whose lipase levels were not measured in the course of COVID-19 Patients with known solid organ malignacy Patients with known hematologic malignacy
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 |
|---|---|---|
| Age, gender, hospitalization and mortality rates will be comparedAge, gender, hospitalization and mortality rates will be compared | Other | Control, patients with higher lipase level |
Primary outcome
The frequency of lipase enzyme elevation will be compared
Time frame: From 31th March 2020 until 9th July 2021
The mortaliy rate will be compared
Time frame: From 31th March 2020 until 9th July 2021
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 1 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatitis and Lipase Increased, run by Uşak University at 1 site in Turkey (Türkiye).
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 1 Nov 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 Turkey (Türkiye). 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?
The frequency of lipase enzyme elevation will be compared (time frame: From 31th March 2020 until 9th July 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.