S Protein and COVID-19: a Monocentric Prospective Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Non-pharmacological, non-interventional, prospective, monocentric study involving the use of biological materials. There will be two cohorts: COVID + cohort: 50 patients with positive nasopharyngeal swab and / or BAL. Control Cohort: 20 patients with non-SARS-CoV-2 related pneumonia. The study involves analyzing biological samples collected for normal clinical practice. In particular: blood samples will be used for PROS and Sflt1 assay, haematological, biochemical and coagulation tests. Samples deriving from nasopharyngeal swab or from Broncho-Alveolar Lavage (BAL) liquid will be used for Real time PCR analysis to evaluate the viral load of SARS CoV-2.

Official Title
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S Protein and COVID-19: a Monocentric Prospective Study

Conditions
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COVID-19

Intervention / Treatment
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* Procedure: Hematolgy and Chemistry analysis
* Procedure: Real Time PCR
* Procedure: PROS assay COVID+
* Procedure: Sflt1 assay COVID+
* Procedure: PROS assay CONTROL
* Procedure: Sflt1 assay CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort COVID + : Subjects aged ≥ 18 years. Signing of the informed consent. Positivity for SARS-CoV-2 by RealTimePCR from nasopharyngeal swab or bronchial wash. Cohort Control: Subjects aged ≥ 18 years. Signing of the informed consent. Diagnosis of pneumonia not related to SARS-CoV-2, demonstrated by negative swab. Exclusion Criteria: Patients with a diagnosis of congenital S Protein deficiency. Patients who are taking oral anticoagulant therapy (TAO) or new oral anticoagulants (NAO). Chronic liver failure (> 5 points on the Child-Pugh score). Female subjects who are pregnant or on estrogen-progestogen replacement therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid +<br>Patients SARS-CoV-2 positive. | Procedure: Hematolgy and Chemistry analysis<br>* Samples will be collected at Day 0, Day 5, Day 10 and Day 15<br>* Other names: Peripheral Blood;Procedure: Real Time PCR<br>* Samples will be collected at Day 0, Day 5, Day 10 and Day 15<br>* Other names: Bronchoalveolar lavage;Procedure: PROS assay COVID+<br>* Samples will be collected at Day 0, Day 5, Day 10 and Day 15<br>* Other names: Peripheral Blood;Procedure: Sflt1 assay COVID+<br>* Samples will be collected at Day 0 and Day 10<br>* Other names: Peripheral Blood;|
| Control<br>Patients with Pneumonia non-SARS-CoV-2 related | Procedure: PROS assay CONTROL<br>* Samples will be collected at Day 0 (+5)<br>* Other names: Peripheral Blood;Procedure: Sflt1 assay CONTROL<br>* Samples will be collected at Day 0 (+5)<br>* Other names: Peripheral Blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PROS, S Protein, SARS-CoV-2, COVID-19