- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05009186
Changing of Prostate Specific Antigen Value in Patients With Covid-19
August 15, 2021 updated by: Omer Gokhan Doluoglu, Saglik Bilimleri Universitesi
Changing of PSA With Covid-19
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a worldwide pandemic in over 100 years.
The disease caused by this newly discovered virus was called Covid-19.
In this study, we aimed to evaluate changing of PSA value in patients with Covid-19.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients with positive PCR test results were included in the study.
The age of the patient and urea, leukocyte, hemoglobin, platelet, urea, and creatinine values of the patients were recorded.
Urinalysis and urine culture were taken from all patients.
Acute phase reactants such as sedimentation, C-reaktif protein (CRP), ferritin, and fibrinogen were measured both at the time the patients applied and three weeks after the patient recovered.
PSA and free PSA were also measured in the same way.
Patients whose symptoms improved and the PCR test result was negative were considered as recovered.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Omer G Doluoglu, Associate Professor
- Phone Number: +905332157809
- Email: drdoluoglu@yahoo.com.tr
Study Locations
-
-
Altindag
-
Ankara, Altindag, Turkey, 06100
- Recruiting
- Omer Gokhan Doluoglu
-
Contact:
- Omer G Doluoglu
- Phone Number: +905332157809
- Email: drdoluoglu@yahoo.com.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male patients (>45 and <70 years of age) positive PCR test results were included in the study
Exclusion Criteria:
- The patients <45 and >70 years of age who described lower urinary tract symptoms who had urinary tract infection who a history of prostate biopsy and previous high level of PSA who history of prostatitis were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Covid-19 group
We will measure the PSA value during and after Covid-19 infection in the same group via paired simple t test
|
We measure PSA value during and after covid-19 infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSA value
Time Frame: 2 months
|
prostate specific antigen
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ferritin, CRP
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Omer G Doluoglu, Associate Professor, Ankara Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
August 15, 2021
First Submitted That Met QC Criteria
August 15, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 15, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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