NCT05601258

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 and acute pancreatitis in the course of COVID 19 disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

October 26, 2022

Last Update Submit

October 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The frequency of lipase enzyme elevation will be compared

    From 31th March 2020 until 9th July 2021

  • The mortaliy rate will be compared

    From 31th March 2020 until 9th July 2021

Study Arms (2)

patients with higher lipase level

patients with higher lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection

Other: Age, gender, hospitalization and mortality rates will be compared

Control

patients with normal lipase levels in the course of SARS-CoV-2 infection

Other: Age, gender, hospitalization and mortality rates will be compared

Interventions

Age, gender, hospitalization and mortality rates will be compared

Controlpatients with higher lipase level

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients with lipase levels measured during COVID-19

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cevdet Duran

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

AgingSexHospitalization

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological PhenomenaReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cevdet Duran

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 1, 2022

Study Start

March 31, 2020

Primary Completion

July 9, 2021

Study Completion

July 9, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations