PancreatitisNCT04433754
The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection
An observational study of Pancreatitis, 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?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- biochemical analysis
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 12 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: Patients who develop amylase and lipase elevation during the course of COVID 19 will be considered in the pancreatic injury group. Those who do not develop will be counted as the control group.
Who may be able to join
- Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia
Who cannot join
- Patients with pregnancy
- Patients whose amylase and lipase levels were not measured during covid 19 disease
- Patients with known solid organ malignacy
- Patients with known hematologic malignacy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University Training and Research Hospital
Uşak, 64200
About this study
Official title: Pancreatic Injury in Patients With COVID-19 Disease
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 in the course of COVID 19 disease.
- Conditions
- Pancreatitis
- Being tested
- biochemical analysis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biochemical analysisOther
cRP, d-dimer levels and lymphocyte counts will be compared
| Study group | Role | What they receive |
|---|---|---|
| patients with pancreatic injury | patients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection Receives: Other: biochemical analysis | |
| patients without pancreatic injury | patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection Receives: Other: biochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare presence of fever in patients with and without pancreatic injury
To evaluate the frequency of presence of fever in patients with and without pancreatic injury
Measured: 3 month
to compare presence of dyspnea in patients with and without pancreatic injury
To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury
Measured: 3 month
To compare cRP levels in patients with and without pancreatic injury
CRP levels will be compared in patients with and without pancreatic injury
Measured: 3 month
To compare d-dimer levels in patients with and without pancreatic injury
D-Dimer levels will be compared in patients with and without pancreatic injury
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Mar 2020
- Primary completion11 Jun 2020
- Study completion12 Jun 2020
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
- 500 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
- NCT04433754
- Sponsor's protocol ID
- UsakU-Cevdet2
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Injury in Patients With COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04433754
- Acronym / sponsor ID
- UsakU-Cevdet2
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 16 Jun 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.
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 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 pancreatic injury | – | Other: biochemical analysispatients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection |
| patients without pancreatic injury | – | Other: biochemical analysispatients with normal amylase and lipase levels in the course of SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who develop amylase and lipase elevation during the course of COVID 19 will be considered in the pancreatic injury group. Those who do not develop will be counted as the control group.
Key inclusion criteria (1 listed)
- Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia
Key exclusion criteria (4 listed)
- Patients with pregnancy
- Patients whose amylase and lipase levels were not measured during covid 19 disease
- 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 |
|---|---|---|
| biochemical analysiscRP, d-dimer levels and lymphocyte counts will be compared | Other | patients with pancreatic injury, patients without pancreatic injury |
Primary outcome
to compare presence of fever in patients with and without pancreatic injury
Time frame: 3 month
To evaluate the frequency of presence of fever in patients with and without pancreatic injury
to compare presence of dyspnea in patients with and without pancreatic injury
Time frame: 3 month
To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury
To compare cRP levels in patients with and without pancreatic injury
Time frame: 3 month
CRP levels will be compared in patients with and without pancreatic injury
To compare d-dimer levels in patients with and without pancreatic injury
Time frame: 3 month
D-Dimer levels will be compared in patients with and without pancreatic injury
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 16 Jun 2020.
- 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, 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 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 16 Jun 2020. 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?
to compare presence of fever in patients with and without pancreatic injury (time frame: 3 month). The study lists 4 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 16 Jun 2020.