Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia

Completed

• Conditions: Corona Virus Infection; Thromboembolic Disease

• Registration Number: NCT04423315
• Lead Sponsor: Istanbul 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.

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.

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study Start: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length of hospital stay	2 months	from admission to discharge expressed in days

Trial Locations

Locations (1)

Vital Hospital; 🇹🇷 Bahcelievler, Istanbul, Turkey