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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClotPro assessment | Diagnostic Test | Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marco Ranucci, MD | IRCCS Policlinico S. Donato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | San Donato Milanese | MI | 20097 | Italy |
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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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D020141 | Hemostatic Disorders |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Laboratory analysis | Diagnostic Test | Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin) |
|
| Interview | Other | 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. |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |