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Pulmonary Embolism and COVID-19 (COVID-19-PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590378
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Uşak University

Brief 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.

Condition or disease Intervention/treatment
Covid-19 Pulmonary Embolism Other: intensive care unit admission ratio

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Patients With COVID-19 in Terms of Pulmonary Embolism
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Covid-19 Patients with Pulmonary embolism
Clinically demonstared cases infected with COVID-19 who developed pulmonary embolism.
Other: intensive care unit admission ratio
intensive care unit admission ratio

Covid-19 Patients without Pulmonary embolism
Clinically demonstared cases infected with COVID-19 who did not develop pulmonary embolism.
Other: intensive care unit admission ratio
intensive care unit admission ratio




Primary Outcome Measures :
  1. pulmonary embolism [ Time Frame: 1 year ]
    development of pulmonary embolism


Secondary Outcome Measures :
  1. Intensive care unit [ Time Frame: 1 year ]
    need for admission to intensive care unit

  2. mortality [ Time Frame: 1 year ]
    mortality rate due to pulmonary embolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

- All patients with positive RT-PCR for COVID-19

Exclusion Criteria:

- All patients with negative RT-PCR for COVID-19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590378


Contacts
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Contact: Cevdet Duran, M.D. +905334298585 drcduran@gmail.com

Locations
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Turkey
Uşak University Recruiting
Usak, Turkey, 64200
Contact: Cevdet Duran, Prof.    02762212121    drcduran@gmail.com   
Sub-Investigator: Canan Akkus, M.D.         
Sub-Investigator: Hakan Yilmaz, M.D.         
Sub-Investigator: Barış Sevinç, M.D.         
Sponsors and Collaborators
Uşak University
Investigators
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Principal Investigator: Cevdet Duran, M.D. Uşak University Medical School
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Responsible Party: Uşak University
ClinicalTrials.gov Identifier: NCT04590378    
Other Study ID Numbers: UU-PE001
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases