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

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Bahcelievler, Istanbul, Turkey, 34230
      • Vital Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	from admission to discharge expressed in days	2 months

Collaborators and Investigators

• Sponsor: Nisantasi University

Publications and helpful links

General Publications

• 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. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: covid-19 pneumonia; thromboembolism risk; length of hospitalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Embolism and Thrombosis; COVID-19; Coronavirus Infections; Pneumonia; Thrombosis; Thromboembolism
• Other Study ID Numbers: 20200504443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD excluding names and personal identity numbers will be shared when the research is ready to be submitted for publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No