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OpenTrials
Completed

NCT Number: NCT05721066

Hemostatic Profile of Post COVID-19/Long COVID-19 Patients

The present study aims at assessing long-term hemostatic profile of patients recovered from COVID-19 acute infection that remain asymptomatic (POST-COVID) versus patients with residual symptoms (LONG-COVID) through the employment of a commercially available new generation point-of-care viscoelastic device. The primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from COVID-19.

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Key information

Conditions

COVID-19 Cardiovascular Diseases Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years;
  • recovery from acute COVID-19 infection;
  • COVID-19 pneumonia that required hospitalization in our Institution;
  • discharge from the hospital minimum 3 months before the day of the visit;
  • written consent to participate to the study.

Exclusion criteria

  • none.

Treatment and study plan

ClotPro assessment

Diagnostic Test

Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)

Laboratory analysis

Diagnostic Test

Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)

interview

Other

Questionnaire from ISS (Istituto Superiore Sanità, the National Health Institute) about the health conditions before the acute COVID-19 infection, the disease (and the hospitalization) details and the eventual health disturbances experienced after the recovery from COVID-19 infection.

Primary outcomes

  1. ClotPro EXTEST

    Time frame: Day of the visit

    Extrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)

  2. ClotPro INTEST

    Time frame: Day of the visit

    Intrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)

  3. ClotPro FIBTEST

    Time frame: Day of the visit

    Fibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)

  4. ClotPro TPATEST

    Time frame: Day of the visit

    Resistance to the fibrinolysis induced by the tPA (tissue plasminogen) as measured by the ClotPro (lysis time, LT, seconds; maximum lysis, ML, %).

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Acronym: LCV

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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