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

COVID-19 Clinical Trial

— LCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721066
• Other study ID #: LONG-COVID-VET
• Status: Completed
• Start date: April 12, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• ClotPro assessment
Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	ClotPro FIBTEST	Fibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)	Day of the visit
Primary	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