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

The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load inCOVID positive patients.

Detailed Description

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.

Recruiting
COVID-19

Procedure: Hematolgy and Chemistry analysis

Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Name: Peripheral Blood

Procedure: Real Time PCR

Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Name: Nasopharyngeal swab,Bronchoalveolar lavage

Procedure: PROS assay COVID+

Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Name: Peripheral Blood

Procedure: Sflt1 assay COVID+

Samples will be collected at Day 0 and Day 10
Other Name: Peripheral Blood

Procedure: PROS assay CONTROL

Samples will be collected at Day 0 (+5)
Other Name: Peripheral Blood

Procedure: Sflt1 assay CONTROL

Samples will be collected at Day 0 (+5)
Other Name: Peripheral Blood

Eligibility Criteria

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:

1. Subjects aged ≥ 18 years.

2. Signing of the informed consent.

3. 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

San Gerardo Hospital
Monza, Lombardia, Italy

Investigator: Luisa Verga, MD
Contact: +39 0392339868
l.verga@asst-monza.it

Contacts

Daniela Ciulla, M.Sc
+392339883
d.ciulla.hsg@gmail.com

Ivan Civettini, MD
+39 039 2339883
ivan.civettini@hotmail.it

Luisa Verga, MD, Study Director
San Gerardo Hospital

San Gerardo Hospital
NCT Number
Keywords
PROS
S Protein
SARS-CoV-2
Covid-19
MeSH Terms
COVID-19
Dimercaprol