Clinical trial NCT04595110: Hemostatic Profile in Patients Affected by COVID-19
Official title: Extensive Investigation of the Hemostatic Profile in a Prospective Cohort of Patients Affected by COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Thrombosis
Keywords: covid19
Hospitalized patients
coagulation
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves the enrollment of ≥ 400 consecutive hospitalized patients diagnosed with COVID-19, aged\> 18 years.

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).


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:

-

Primary outcomes:
measure: Incidence of mortality among enrolled COVID-19 patients
timeFrame: up to 6 months from the date of the enrollment
measure: Incidence of thrombosis among enrolled COVID patients
timeFrame: up to 12 months from the date of the enrollment
Secondary outcomes:
measure: Evaluation the role of enoxaparin in the management of Covid-19-associated coagulopathy
timeFrame: Samples collected from identified participants with COVID19 diagnosis will be assessed to determine the effect of thromboprophylaxis on thrombotic and inflammatory biomarkers
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital - S.I.M.T.
Study officials:
References: