The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection

• Sponsor: Uşak University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04433754
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 147.8

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis	Other: biochemical analysis

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Pancreatic Injury in Patients With COVID-19 Disease
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Jun 11, 2020
• Actual Study Completion Date: Jun 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Other: biochemical analysis; cRP, d-dimer levels and lymphocyte counts will be compared
patients without pancreatic injury patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection	Other: biochemical analysis; cRP, d-dimer levels and lymphocyte counts will be compared

Outcome Measures

Primary Outcome Measures

1. to compare presence of fever in patients with and without pancreatic injury [3 month]

   To evaluate the frequency of presence of fever in patients with and without pancreatic injury

2. to compare presence of dyspnea in patients with and without pancreatic injury [3 month]

   To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury

3. To compare cRP levels in patients with and without pancreatic injury [3 month]

   CRP levels will be compared in patients with and without pancreatic injury

4. To compare d-dimer levels in patients with and without pancreatic injury [3 month]

   D-Dimer levels will be compared in patients with and without pancreatic injury

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Usak University Training and Research Hospital	Usak		Turkey	64200

Sponsors and Collaborators

• Uşak University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cevdet Duran, Professor, M.D., Uşak University
• ClinicalTrials.gov Identifier: NCT04433754
• Other Study ID Numbers: UsakU-Cevdet2
• First Posted: Jun 16, 2020
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis

Study Results

No Results Posted as of Jun 16, 2020