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)
• Enrollment: 102
• Location: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 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
COVID-19; Post-acute COVID-19 Syndrome	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: COVID-19; Post-acute COVID-19 Syndrome; Coagulopathy; Fibrinolysis; Thrombosis
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Feb 16, 2023