Covid19NCT05009186
Changing of Prostate Specific Antigen Value in Patients With Covid-19
A study testing PSA value in people with Covid19 and Prostate Specific Antigen, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Covid19, Prostate Specific Antigen
- What is being tested?
- PSA value
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 1 Oct 2021
- Phase
- Interventional
- 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 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients (>45 and <70 years of age) positive PCR test results were included in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Omer Gokhan Doluoglu
Ankara, Altindag, 06100
Omer G Doluoglu, +905332157809, drdoluoglu@yahoo.com.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Prostate Specific Antigen
- Being tested
- PSA value
- Keywords
- Covid-19, Prostate cancer, Prostate Specific Antigen
- Medical subject headings
- COVID-19, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA valueOther
We measure PSA value during and after covid-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 group | Other | We will measure the PSA value during and after Covid-19 infection in the same group via paired simple t test Receives: Other: PSA value |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA value
prostate specific antigen
Measured: 2 months
Secondary outcomes (1)
Ferritin, CRP
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Apr 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We measured PSA value during and after Covid-19 infection
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Gokhan Doluoglu, Saglik Bilimleri Universitesi
- Investigators
- Omer G Doluoglu, Associate Professor, Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009186
- Sponsor's protocol ID
- PSA
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing of PSA With Covid-19
- ClinicalTrials.gov ID
- NCT05009186
- Acronym / sponsor ID
- PSA
- Conditions
- Covid19, Prostate Specific Antigen
- Keywords
- Covid-19, Prostate cancer, Prostate Specific Antigen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 17 Aug 2021 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We measured PSA value during and after Covid-19 infection
| Arm | Type | Receives |
|---|---|---|
| Covid-19 group | Other | Other: PSA valueWe will measure the PSA value during and after Covid-19 infection in the same group via paired simple t test |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients (>45 and <70 years of age) positive PCR test results were included in the study
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| PSA valueWe measure PSA value during and after covid-19 infection | Other | Covid-19 group |
Primary outcome
PSA value
Time frame: 2 months
prostate specific antigen
1 secondary outcome
Ferritin, CRP
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Omer G Doluoglu, Associate Professor principal investigator
Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA value in people with Covid19 and Prostate Specific Antigen, run by Saglik Bilimleri Universitesi 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 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer G Doluoglu, Associate Professor (+905332157809, drdoluoglu@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA value (time frame: 2 months). 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 17 Aug 2021.