Hemostatic Profile in Patients Affected by COVID-19

NCT04595110 | Unknown DMC

• 1 other identifier: EMO-COVID-ASSTPG23
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

covid19; Hospitalized patients; coagulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Evaluation the role of enoxaparin in the management of Covid-19-associated coagulopathy

  Samples collected from identified participants with COVID19 diagnosis will be assessed to determine the effect of thromboprophylaxis on thrombotic and inflammatory biomarkers

Interventions

Observational study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study involves the enrollment of ≥ 400 consecutive hospitalized patients diagnosed with COVID-19, aged\> 18 years.

You may qualify if:

• 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.

Sponsors & Collaborators

• ANNA FALANGA: lead

Study Sites (1)

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

Bergamo, 24127, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for hemostasis study are collected from all study subjects at admission. After discarding the first 2-3 mL of blood, peripheral venous blood samples were collected into 6 mL vacuum tubes (BD, Vacutainer ™, Plymouth, UK) containing 3.2% citrate (0.109 mol/L, 1:9 vol./vol.) for coagulation studies, and K3-ethylenediamine tetraacetic acid (K3-EDTA) 7.2mg for the complete blood cell count study.

MeSH Terms

Conditions

COVID-19; Thrombosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 20, 2020
• Study Start: March 25, 2020
• Primary Completion: April 25, 2021
• Study Completion: May 10, 2021
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)