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

Completed

• Conditions: Post-acute COVID-19 Syndrome; COVID-19

• Registration Number: NCT05721066
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-09
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ClotPro FIBTEST	Day of the visit	Fibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)
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)
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, %).
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)

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy