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Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia (Covid-19)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423315
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Murat Civan, Nisantasi University

Brief Summary:
Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. In this study, the association between thrombosis risk and clinical presentation of Covid-19 is investigated.

Condition or disease
Corona Virus Infection Thromboembolic Disease

Detailed Description:

The severe acute respiratory distress syndrome related coronavirus-2 (SARS-CoV-2) and its clinical presentation as Coronavirus disease 2019 (COVID-19) was first reported in Wuhan, Hubei, China in December 2019. It has spread rapidly from its origin in Wuhan City to other countries of the world over the last several months.

Although it mainly affects the respiratory system , multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. SARS-CoV-2 infection may also lead to thrombotic disease both in the venous and arterial circulation of patients apart from respiratory system due to excessive inflammation, thrombocyte activation, endothelial malfunction, and stasis.

Investigators have reported that both CHADS2 and CHA2DS2-VASc scores were related to mortality in individuals that had stable coronary angina, acute coronary syndrome, Takotsubo syndrome or sick sinus syndrome, apart from atrial fibrillation . In addition, thrombocyte/lymphocyte (PLT/LYM) and neutrophil/lymphocyte (NEU/LYM) ratios on admission were also related with thromboembolic complications in former studies which found them useful to predict prognosis of acute pulmonary embolism, as being one of the thromboembolic complications of Covid-19.

Investigators suggest that the parameters mentioned above should also be studied in terms of thrombotic complications of Covid-19. Thus they aimed to find out potential associations between markers of prothrombotic or inflammatory conditions and some clinical features of Covid-19 pneumonia cases on admission and follow-up.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Thrombosis Risk Assessment May Predict Clinical Presentation and Length of Hospital Stay in Covid-19 Pneumonia
Actual Study Start Date : June 8, 2020
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
patients with covid-19 pneumonia
patients with covid-19 pneumonia above 18 years old who were diagnosed by pcr testing and computed tomography of thorax



Primary Outcome Measures :
  1. length of hospital stay [ Time Frame: 2 months ]
    from admission to discharge expressed in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COVID - 19 pneumonia diagnosed in the emergency, internal medicine and cardiology outpatient clinics will be included
Criteria

Inclusion Criteria:

  • patients diagnosed with COVID - 19 pneumonia between March 11 th , 2020 and April 25th, 2020 in the emergency, internal medicine and cardiology outpatient clinics.
  • patients diagnosed by pcr testing and computed tomography of the chest

Exclusion Criteria:

  • patients below 18 years of age
  • patients with an alternative aetiology of pneumonia

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): NCT04423315


Locations
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Turkey
Vital Hospital
Bahcelievler, Istanbul, Turkey, 34230
Sponsors and Collaborators
Nisantasi University
Publications:
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Responsible Party: Murat Civan, M.D., Nisantasi University
ClinicalTrials.gov Identifier: NCT04423315    
Other Study ID Numbers: 20200504443
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD excluding names and personal identity numbers will be shared when the research is ready to be submitted for publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Civan, Nisantasi University:
covid-19 pneumonia
thromboembolism risk
length of hospitalization
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Thrombosis
Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections