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

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Completed
CT.gov ID
NCT05721066
Collaborator
(none)
102
1
7.1
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ClotPro assessment
  • Diagnostic Test: Laboratory analysis
  • Other: Interview

Study Design

Study Type:
Observational
Actual Enrollment :
102 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Hemostatic Profile of Post COVID-19/Long COVID-19 Patients
Actual Study Start Date :
Apr 12, 2022
Actual Primary Completion Date :
Nov 15, 2022
Actual Study Completion Date :
Nov 15, 2022

Arms and Interventions

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

Diagnostic Test: Laboratory analysis
Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)

Other: Interview
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

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

Diagnostic Test: Laboratory analysis
Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)

Other: Interview
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.

Outcome Measures

Primary Outcome Measures

  1. ClotPro EXTEST [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 [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 [Day of the visit]

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

  4. ClotPro TPATEST [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, %).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Policlinico San Donato San Donato Milanese MI Italy 20097

Sponsors and Collaborators

  • IRCCS Policlinico S. Donato

Investigators

  • Principal Investigator: Marco Ranucci, MD, IRCCS Policlinico S. Donato

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marco Ranucci, Dr, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT05721066
Other Study ID Numbers:
  • LONG-COVID-VET
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marco Ranucci, Dr, IRCCS Policlinico S. Donato
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2023