Hemostatic Profile in Patients Affected by COVID-19

Covid19 Clinical Trial

— EMO-COVID  

Official title:

Extensive Investigation of the Hemostatic Profile in a Prospective Cohort of Patients Affected by COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595110
• Other study ID #: EMO-COVID-ASSTPG23
• Status: Recruiting
• Start date: March 25, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: October 2020
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 10, 2021
• Est. primary completion date: April 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Covid19
• Thrombosis

Intervention

Other:
• Observational study
Coagulation factors, Hypercoagulation biomarkers, Endothelial, Fibrinolysis and neutrophil activation biomarkers

Locations

Country	Name	City	State
Italy	Papa Giovanni XXIII Hospital - S.I.M.T.	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
ANNA FALANGA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of mortality among enrolled COVID-19 patients	Identification of variables for prediction of mortality derived from review of clinical records. Samples collected from identified participants with COVID19 diagnosis will be assessed to determine thrombotic and inflammatory biomarkers able to prediction of mortality.	up to 6 months from the date of the enrollment
Primary	Incidence of thrombosis among enrolled COVID patients	Identification of COVID-19 patients with evidence of thrombotic event derived from review of clinical records. Samples collected from identified participants with COVID19 diagnosis will be assessed to determine thrombotic and inflammatory biomarkers.	up to 12 months from the date of the enrollment
Secondary	Evaluation the role of enoxaparin in the management of Covid-19-associated coagulopathy	up to 12 months from the date of the enrollment	Samples collected from identified participants with COVID19 diagnosis will be assessed to determine the effect of thromboprophylaxis on thrombotic and inflammatory biomarkers