Covid-19COVID-19-PENCT04590378
Pulmonary Embolism and COVID-19
An observational study of Covid-19 and Pulmonary Embolism, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid-19, Pulmonary Embolism
- What is being tested?
- intensive care unit admission ratio
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Dec 2021
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All COVID-19 patients with positive RT-PCR tests will be analyzed retrospectively. Patients with and without pulmonary embolism will be compared in terms of age, gender, side disease, hospitalization in intensive care, mortality rates etc.
Who may be able to join
- All patients with positive RT-PCR for COVID-19
Who cannot join
- All patients with negative RT-PCR for COVID-19
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uşak University
Uşak, 64200
Cevdet Duran, Prof., 02762212121, drcduran@gmail.com
Canan Akkus, M.D.
About this study
Official title: Evaluation of the Patients With COVID-19 in Terms of Pulmonary Embolism
The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.
Read the detailed description
Patients with COVID-19 infection will be evaluated retrospectively. Demographic data, clinical and laboratory findings will be recorded. Findings of patients with pulmonary embolism and withour pulmonary embolism will be compared.
- Conditions
- Covid-19, Pulmonary Embolism
- Being tested
- intensive care unit admission ratio
- Medical subject headings
- COVID-19, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive care unit admission ratioOther
intensive care unit admission ratio
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Patients with Pulmonary embolism | Clinically demonstared cases infected with COVID-19 who developed pulmonary embolism. Receives: Other: intensive care unit admission ratio | |
| Covid-19 Patients without Pulmonary embolism | Clinically demonstared cases infected with COVID-19 who did not develop pulmonary embolism. Receives: Other: intensive care unit admission ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary embolism
development of pulmonary embolism
Measured: 1 year
Secondary outcomes (2)
Intensive care unit
need for admission to intensive care unit
Measured: 1 year
mortality
mortality rate due to pulmonary embolism
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cevdet Duran, M.D., Principal investigator, Uşak University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590378
- Sponsor's protocol ID
- UU-PE001
- Acronym
- COVID-19-PE
- Status last verified
- May 2021
- First submitted
- 14 Oct 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Patients With COVID-19 in Terms of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04590378
- Acronym / sponsor ID
- COVID-19-PE / UU-PE001
- Conditions
- Covid-19, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.
Detailed description
Patients with COVID-19 infection will be evaluated retrospectively. Demographic data, clinical and laboratory findings will be recorded. Findings of patients with pulmonary embolism and withour pulmonary embolism will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Patients with Pulmonary embolism | – | Other: intensive care unit admission ratioClinically demonstared cases infected with COVID-19 who developed pulmonary embolism. |
| Covid-19 Patients without Pulmonary embolism | – | Other: intensive care unit admission ratioClinically demonstared cases infected with COVID-19 who did not develop pulmonary embolism. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All COVID-19 patients with positive RT-PCR tests will be analyzed retrospectively. Patients with and without pulmonary embolism will be compared in terms of age, gender, side disease, hospitalization in intensive care, mortality rates etc.
Key inclusion criteria (1 listed)
- All patients with positive RT-PCR for COVID-19
Key exclusion criteria (1 listed)
- All patients with negative RT-PCR for COVID-19
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 |
|---|---|---|
| intensive care unit admission ratiointensive care unit admission ratio | Other | Covid-19 Patients with Pulmonary embolism, Covid-19 Patients without Pulmonary embolism |
Primary outcome
pulmonary embolism
Time frame: 1 year
development of pulmonary embolism
2 secondary outcomes
Intensive care unit
Time frame: 1 year
mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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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.
Cevdet Duran, M.D. principal investigator
Uşak University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Pulmonary Embolism, run by Uşak University 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 4 May 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 Cevdet Duran, M.D. (+905334298585, drcduran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary embolism (time frame: 1 year). 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 4 May 2021.