Hemostatic Profile in Patients Affected by COVID-19

NCT ID: NCT04595110

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-25
• Study Completion Date: 2021-05-10

Brief Summary

Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been associated with the occurrence of cardiovascular adverse events including acute myocardial injury, acute heart failure, cardiac arrhythmias, and thromboembolic disease. These complications represent an important issue in COVID-19 patients accounting for the increased morbidity and mortality of this syndrome. According to a scoping review, venous thromboembolism and stroke occurred in approximately 20% and 3% of patients, respectively, with higher frequency observed in severely ill patients admitted to intensive care units. Despite the use of pharmacological thromboprophylaxis, the thrombotic risk still remained elevated in severe COVID-19 patients, and the optimal doses and timing of anticoagulation are not yet defined. The pathogenesis of COVID-19 associated thrombosis recognizes a prominent role of endothelial damage induced by both direct viral injury and an excessive and aberrant hyper-inflammatory host immune response associated to an increase in infection-related cytokines and chemokines. The occurrence of a hypercoagulable state in COVID-19 patients associated to a profound endothelial cell activation/dysfunction can result in the pathological phenomenon of immunothrombosis.

In this study, in a prospective cohort of consecutive COVID-19 hospitalized patients, an extensive characterization of the hemostatic alterations were performed, in order to: 1) clarify mechanisms underlying the coagulopathy in these patients; 2) how and to what extent the concomitant infection with SARS-CoV-2 affect this coagulopathy; and 3) identify biomarkers potentially predictive of disease outcome (i.e. any thrombotic recurrence and death).

Conditions

Covid19; Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observational study

Coagulation factors, Hypercoagulation biomarkers, Endothelial, Fibrinolysis and neutrophil activation biomarkers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age> 18 years
• Adult patients admitted with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positivity (by real time-PCR) from nasal swab or deep respiratory specimen or with clinical signs suggestive of SARS-Cov-2
• Patients who have signed informed consent. If there is no possibility of obtaining informed consent for the clinical picture (eg adult patients sedated and curarized for acute respiratory failure and consequent mechanical ventilation), the patient's consent will be assumed until the contrary will be manifested.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANNA FALANGA

OTHER

Sponsor Role: lead

Responsible Party

ANNA FALANGA

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Papa Giovanni XXIII Hospital - S.I.M.T.

Bergamo, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Anna Falanga, MD

Role: primary

annafalanga@icthic.com

+390352674776

Laura Russo, BSc

Role: backup

laurarusso78@yahoo.it

Other Identifiers

EMO-COVID-ASSTPG23

Identifier Type: -

Identifier Source: org_study_id