Hemostatic Profile in Patients Affected by COVID-19 (EMO-COVID)

• ClinicalTrials.gov Identifier: NCT04595110
• Recruitment Status: Recruiting
• First Posted: October 20, 2020
• Last Update Posted: October 20, 2020
• Sponsor: ANNA FALANGA
• Information provided by (Responsible Party): ANNA FALANGA, A.O. Ospedale Papa Giovanni XXIII

Study Description

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).

Condition or disease	Intervention/treatment
Covid19; Thrombosis	Other: Observational study

Study Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Extensive Investigation of the Hemostatic Profile in a Prospective Cohort of Patients Affected by COVID-19
• Actual Study Start Date: March 25, 2020
• Estimated Primary Completion Date: April 25, 2021
• Estimated Study Completion Date: May 10, 2021

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of mortality among enrolled COVID-19 patients [ Time Frame: up to 6 months from the date of the enrollment ]
   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.
2. Incidence of thrombosis among enrolled COVID patients [ Time Frame: up to 12 months from the date of the enrollment ]
   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.

Secondary Outcome Measures :

1. Evaluation the role of enoxaparin in the management of Covid-19-associated coagulopathy [ Time Frame: Samples collected from identified participants with COVID19 diagnosis will be assessed to determine the effect of thromboprophylaxis on thrombotic and inflammatory biomarkers ]
   up to 12 months from the date of the enrollment

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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:

-

Contacts and Locations

Locations

Italy

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

Bergamo, Italy, 24127

Contact: Anna Falanga, MD +390352674776 annafalanga@icthic.com

Contact: Laura Russo, BSc laurarusso78@yahoo.it

Sponsors and Collaborators

ANNA FALANGA

More Information

• Responsible Party: ANNA FALANGA, Principal Investigator, A.O. Ospedale Papa Giovanni XXIII
• ClinicalTrials.gov Identifier: NCT04595110
• Other Study ID Numbers: EMO-COVID-ASSTPG23
• First Posted: October 20, 2020
• Last Update Posted: October 20, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ANNA FALANGA, A.O. Ospedale Papa Giovanni XXIII:

covid19; Hospitalized patients; coagulation

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases