Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia

Corona Virus Infection Clinical Trial

— Covid-19  

Official title:

Thrombosis Risk Assessment May Predict Clinical Presentation and Length of Hospital Stay in Covid-19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423315
• Other study ID #: 20200504443
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: July 20, 2020

Study information

• Verified date: September 2020
• Source: Nisantasi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 20, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Pneumonia
• Severe Acute Respiratory Syndrome
• Thromboembolic Disease
• Thromboembolism
• Thrombosis

Locations

Country	Name	City	State
Turkey	Vital Hospital	Bahcelievler	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Nisantasi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198. — View Citation

Wang Q, Ma J, Jiang Z, Ming L. Prognostic value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in acute pulmonary embolism: a systematic review and meta-analysis. Int Angiol. 2018 Feb;37(1):4-11. doi: 10.23736/S0392-9590.17.03848-2. Epub 2017 May 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay	from admission to discharge expressed in days	2 months