- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04590378
Pulmonary Embolism and COVID-19 (COVID-19-PE)
May 1, 2021 updated by: Uşak University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
600
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: Cevdet Duran, M.D.
- Phone Number: +905334298585
- Email: drcduran@gmail.com
Study Locations
-
-
-
Usak, Turkey, 64200
- Recruiting
- Uşak University
-
Contact:
- Cevdet Duran, Prof.
- Phone Number: 02762212121
- Email: drcduran@gmail.com
-
Sub-Investigator:
- Canan Akkus, M.D.
-
Sub-Investigator:
- Hakan Yilmaz, M.D.
-
Sub-Investigator:
- Barış Sevinç, M.D.
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- All patients with positive RT-PCR for COVID-19
Exclusion Criteria:
- All patients with negative RT-PCR for COVID-19
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Covid-19 Patients with Pulmonary embolism
Clinically demonstared cases infected with COVID-19 who developed pulmonary embolism.
|
intensive care unit admission ratio
|
Covid-19 Patients without Pulmonary embolism
Clinically demonstared cases infected with COVID-19 who did not develop pulmonary embolism.
|
intensive care unit admission ratio
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulmonary embolism
Time Frame: 1 year
|
development of pulmonary embolism
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensive care unit
Time Frame: 1 year
|
need for admission to intensive care unit
|
1 year
|
mortality
Time Frame: 1 year
|
mortality rate due to pulmonary embolism
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cevdet Duran, M.D., Uşak University Medical School
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)
March 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 14, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
May 1, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Embolism and Thrombosis
- COVID-19
- Embolism
- Pulmonary Embolism
Other Study ID Numbers
- UU-PE001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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