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

NCT05721066 | Completed

• 1 other identifier: LONG-COVID-VET
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Post-acute COVID-19 Syndrome

Keywords

COVID-19; Post-acute COVID-19 Syndrome; Coagulopathy; Fibrinolysis; Thrombosis

Outcome Measures

Primary Outcomes (4)

• ClotPro EXTEST

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

  Day of the visit

• ClotPro INTEST

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

  Day of the visit

• ClotPro FIBTEST

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

  Day of the visit

• ClotPro TPATEST

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

  Day of the visit

Study Arms (2)

POST-COVID

Patients hospitalized due to acute COVID-19 pneumonia and discharged home. No residual symptoms after recovery. Contacted by phone and invited to an in-person interview about their health conditions and a blood withdrawal for the assessment of the coagulation profile (both in standard laboratory and point-of-care device ClotPro).

Diagnostic Test: ClotPro assessment; Diagnostic Test: Laboratory analysis; Other: Interview

LONG-COVID

Patients hospitalized due to acute COVID-19 pneumonia and discharged home. Presence of residual symptoms after recovery or new symptoms appeared after discharge not otherwise explained. Contacted by phone and invited to an in-person interview about their health conditions and a blood withdrawal for the assessment of the coagulation profile (both in standard laboratory and point-of-care device ClotPro).

Diagnostic Test: ClotPro assessment; Diagnostic Test: Laboratory analysis; Other: Interview

Interventions

ClotPro assessment DIAGNOSTIC_TEST

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

LONG-COVID; POST-COVID

Laboratory analysis DIAGNOSTIC_TEST

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

LONG-COVID; POST-COVID

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.

LONG-COVID; POST-COVID

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 list of the patients hospitalized in our Institution due to COVID-19 pneumonia (positive COVID-19 test and radiological pneumonia diagnosis) was retrieved. The patients were recruited through a phone contact, those who were reachable and agreed to participate received an appointment for the in-person study-related procedures at our Hospital. The eligible patient population was represented by subjects hospitalized at out Institution for COVID-19 infection between January 1, 2021, and July 31, 2022. The planned patient population was 100 patients. The final patient population comprised 102 subjects.

You may qualify if:

• 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.

You may not qualify if:

• none.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Hemostatic Disorders; Thrombosis

Interventions

Interviews as Topic

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marco Ranucci, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 9, 2023
• Study Start: April 12, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

IT (1)