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

Study Overview
=================
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.

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

Conditions
-----------------
COVID-19, Post-acute COVID-19 Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: ClotPro assessment
* Diagnostic Test: Laboratory analysis
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POST-COVID<br>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<br>* Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)<br>Diagnostic Test: Laboratory analysis<br>* Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)<br>Other: Interview<br>* 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.<br>|
| LONG-COVID<br>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<br>* Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)<br>Diagnostic Test: Laboratory analysis<br>* Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)<br>Other: Interview<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Post-acute COVID-19 Syndrome, Coagulopathy, Fibrinolysis, Thrombosis