COVID-19LCVNCT05721066
Hemostatic Profile of Post COVID-19/Long COVID-19 Patients
An observational study of COVID-19 and Post-acute COVID-19 Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Post-acute COVID-19 Syndrome
- What is being tested?
- ClotPro assessment, Laboratory analysis and Interview
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2022to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The list of the patients hospitalized in our Institution due to COVID-19 pneumonia (positive COVID-19 test and radiological pneumonia diagnosis) was retrieved. The patients were recruited through a phone contact, those who were reachable and agreed to participate received an appointment for the in-person study-related procedures at our Hospital. The eligible patient population was represented by subjects hospitalized at out Institution for COVID-19 infection between January 1, 2021, and July 31, 2022. The planned patient population was 100 patients. The final patient population comprised 102 subjects.
Who may be able to join
- 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.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID-19, Post-acute COVID-19 Syndrome
- Being tested
- ClotPro assessment, Laboratory analysis, Interview
- Keywords
- COVID-19, Post-acute COVID-19 Syndrome, Coagulopathy, Fibrinolysis, Thrombosis
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotPro assessmentDiagnostic test
Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)
Laboratory analysisDiagnostic test
Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)
InterviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: ClotPro assessment; Diagnostic Test: Laboratory analysis; Other: Interview | |
| 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). Receives: Diagnostic Test: ClotPro assessment; Diagnostic Test: Laboratory analysis; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
ClotPro EXTEST
Extrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)
Measured: 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)
Measured: Day of the visit
ClotPro FIBTEST
Fibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)
Measured: 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, %).
Measured: Day of the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start12 Apr 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
- Investigators
- Marco Ranucci, MD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721066
- Sponsor's protocol ID
- LONG-COVID-VET
- Acronym
- LCV
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The original dataset supporting the findings of this study will be deposited in the public repository Zenodo after the publication of the paper and accessible upon a reasonable request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Profile of Post COVID-19/Long COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05721066
- Acronym / sponsor ID
- LCV / LONG-COVID-VET
- Conditions
- COVID-19, Post-acute COVID-19 Syndrome
- Keywords
- COVID-19, Post-acute COVID-19 Syndrome, Coagulopathy, Fibrinolysis, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POST-COVID | – | Diagnostic Test: ClotPro assessment, Diagnostic Test: Laboratory analysis, Other: InterviewPatients 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). |
| LONG-COVID | – | Diagnostic Test: ClotPro assessment, Diagnostic Test: Laboratory analysis, Other: InterviewPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The list of the patients hospitalized in our Institution due to COVID-19 pneumonia (positive COVID-19 test and radiological pneumonia diagnosis) was retrieved. The patients were recruited through a phone contact, those who were reachable and agreed to participate received an appointment for the in-person study-related procedures at our Hospital. The eligible patient population was represented by subjects hospitalized at out Institution for COVID-19 infection between January 1, 2021, and July 31, 2022. The planned patient population was 100 patients. The final patient population comprised 102 subjects.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClotPro assessmentPoint-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis) | Diagnostic test | LONG-COVID, POST-COVID |
| Laboratory analysisBlood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin) | Diagnostic test | LONG-COVID, POST-COVID |
| InterviewQuestionnaire 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. | Other | LONG-COVID, POST-COVID |
Primary outcome
ClotPro EXTEST
Time frame: Day of the visit
Extrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)
ClotPro INTEST
Time frame: Day of the visit
Intrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)
ClotPro FIBTEST
Time frame: Day of the visit
Fibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)
ClotPro TPATEST
Time frame: 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, %).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided. The original dataset supporting the findings of this study will be deposited in the public repository Zenodo after the publication of the paper and accessible upon a reasonable request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Ranucci, MD principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Post-acute COVID-19 Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ClotPro EXTEST (time frame: Day of the visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.