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| Name | Class |
|---|---|
| San Gerardo Hospital | OTHER |
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The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.
Non-pharmacological, non-interventional, prospective, monocentric study involving the use of biological materials.
There will be two cohorts:
The study involves analyzing biological samples collected for normal clinical practice.
In particular:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid + | Patients SARS-CoV-2 positive. |
| |
| Control | Patients with Pneumonia non-SARS-CoV-2 related |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematolgy and Chemistry analysis | Procedure | Samples will be collected at Day 0, Day 5, Day 10 and Day 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PROS levels compared to early stage of SARS-CoV-2 infection. | To demonstrate a correlation between low plasma PROS levels and the early stage of SARS-CoV-2 infection, defined as the first 10 days after onset of symptoms. | Day 0 |
| Plasma PROS levels compared to early stage of SARS-CoV-2 infection. | To demonstrate a correlation between low plasma PROS levels and the early stage of SARS-CoV-2 infection, defined as the first 10 days after onset of symptoms. | Day +5 |
| Plasma PROS levels compared to early stage of SARS-CoV-2 infection. | To demonstrate a correlation between low plasma PROS levels and the early stage of SARS-CoV-2 infection, defined as the first 10 days after onset of symptoms. | Day +10 |
| Plasma PROS levels compared to early stage of SARS-CoV-2 infection. | To demonstrate a correlation between low plasma PROS levels and the early stage of SARS-CoV-2 infection, defined as the first 10 days after onset of symptoms. | Day +15 |
| Plasma PROS level compared to SARS-Cov-2 viral load | To demonstrate a correlation between PROS and the viral load of SARS-CoV-2 | Day 0 |
| Plasma PROS level compared to SARS-Cov-2 viral load | To demonstrate a correlation between PROS and the viral load of SARS-CoV-2 | Day+5 |
| Plasma PROS level compared to SARS-Cov-2 viral load |
| Measure | Description | Time Frame |
|---|---|---|
| Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related | To confirm the non-consumption of protein S in Pneumonia other than SARS-CoV-2. | Day 0, Day +5 |
| Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients. |
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Inclusion Criteria:
Cohort COVID + :
Cohort Control:
Exclusion Criteria:
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Patients with Pneumonia SARS-CoV-2 related or not related
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Ciulla, M.Sc | Contact | +392339883 | d.ciulla.hsg@gmail.com | |
| Ivan Civettini, MD | Contact | +39 039 2339883 | ivan.civettini@hotmail.it |
| Name | Affiliation | Role |
|---|---|---|
| Luisa Verga, MD | San Gerardo Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gerardo Hospital | Recruiting | Monza | Lombardy | 20900 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D060888 | Real-Time Polymerase Chain Reaction |
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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Nasopharyngeal swab, Bronchoalveolar lavage, Peripheral blood
| Real Time PCR | Procedure | Samples will be collected at Day 0, Day 5, Day 10 and Day 15 |
|
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| PROS assay COVID+ | Procedure | Samples will be collected at Day 0, Day 5, Day 10 and Day 15 |
|
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| Sflt1 assay COVID+ | Procedure | Samples will be collected at Day 0 and Day 10 |
|
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| PROS assay CONTROL | Procedure | Samples will be collected at Day 0 (+5) |
|
|
| Sflt1 assay CONTROL | Procedure | Samples will be collected at Day 0 (+5) |
|
|
To demonstrate a correlation between PROS and the viral load of SARS-CoV-2 |
| Day+10 |
| Plasma PROS level compared to SARS-Cov-2 viral load | To demonstrate a correlation between PROS and the viral load of SARS-CoV-2 | Day+15 |
To confirm normalization of plasma S Potein levels longitudinally during the late stages of SARS-CoV-2 infection. |
| Day 0, Day +5, Day +10, Day+15 |
| Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease | To detect any correlations between plasma levels of S Protein and already known parameters indicative of SARS-CoV-2 disease severity (e.g. days spent in O2 at high flows or the need for intubation; access to the Intensive Care Unit; appearance of arterial or venous thromboembolic events; coagulation activation markers; markers of inflammatory or cytokine phase; mortality). | Day 0, Day +5, Day +10, Day+15 |
| Plasma protein S as an index for use of immunosuppressive therapy. | To use protein S values as an indicator for the introduction of immunosuppressive drugs in therapy in patients with COVID-19 disease. | Day 0, Day +5, Day +10, Day+15 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007507 | Therapeutic Irrigation |