NCT04433754

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 12, 2020

Last Update Submit

June 15, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    3 month

Study Arms (2)

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

patients without pancreatic injury

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

Other: biochemical analysis

Interventions

cRP, d-dimer levels and lymphocyte counts will be compared

patients with pancreatic injurypatients without pancreatic injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak University Training and Research Hospital

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D.

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

March 1, 2020

Primary Completion

June 11, 2020

Study Completion

June 12, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations