Coagulopathy and Vasculopathy Assessment as a Predictor of the Severity of SARS-CoV-2 / COVID-19 Infection

NCT04624997 | Unknown

• 2 other identifiers: APHP2005212020-A01048-31
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance. Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 infection; Hemostasis; Coagulopathy; Vasculopathy Assessment; Anticoagulant therapy

Outcome Measures

Primary Outcomes (2)

• Measure D-dimers (ng/ml) to study coagulopathy to characterize COVID-19

  Characterize COVID-19 and identify patient populations who will develop or aggravate a micro or macro thrombotic process

  28 days

• Measure fibrin monomers (µg/ml) to study coagulopathy to characterize COVID-19

  Characterize COVID-19 and identify patient populations who will develop or aggravate a micro or macro thrombotic process

  28 days

Secondary Outcomes (7)

• Study troponin (ng/ml) to characterize COVID-19 and identify patient populations who will develop or aggravate a micro or macro thrombotic process

  28 days

• Study von Willebrand factor antigen (%) to characterize COVID-19 and identify patient populations who will develop or aggravate a micro or macro thrombotic process

  28 days

• Study association of genetical and constitutive factors of thrombophilia :blood type ABO and COVID-19 severity according to OMS classification

  28 days

• Study association of genetical and constitutive factors of thrombophilia: deficit in S protein and COVID-19 severity according to OMS classification

  28 days

• Study association of genetical and constitutive factors of thrombophilia:deficit in C protein and COVID-19 severity according to OMS classification

  28 days

Study Arms (1)

Patient suspected COVID-19

Follow-up of patients as usual in care for infection. No specific puncture. Blood sample collect at admission and every 72h during hospitalisation for hemostasis evaluation, DNA extraction, Circulating endothelial cells measuring. Sampling can be delayed for 24h to match a planned blood collection for care or other research.

Other: biological sample

Interventions

biological sample OTHER

biological sample

Patient suspected COVID-19

Eligibility Criteria

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

Study Population

Public hospital patients

You may qualify if:

• Patients at least 18 years old
• Hospitalized for suspected COVID-19 in the medical wards or intensive care unit.
• Patients benefiting from a social security scheme
• Patient who has been informed of the study

You may not qualify if:

• Patients under guardianship / curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Research Agency, France: collaborator

Study Sites (2)

Hôpital Cochin

Paris, 75014, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, pellet

MeSH Terms

Conditions

COVID-19; Hemostatic Disorders

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; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• David M Smadja

  HEGP, AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Smadja

CONTACT

+33156093933; david.smadja@aphp.fr

Cléo BOURGEOIS

CONTACT

+33156095638; cleo.bourgeois@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: November 12, 2020
• Study Start: June 8, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Locations

FR (2)