Clinical trial NCT05351385: S Protein and COVID-19: a Monocentric Prospective Study
Official title: S Protein and COVID-19: a Monocentric Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: PROS
S Protein
SARS-CoV-2
COVID-19
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: San Gerardo Hospital
First posted: 2022-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pneumonia SARS-CoV-2 related or not related

Brief summary: The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID 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.

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.

Primary outcomes:
measure: Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
timeFrame: Day 0
measure: Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
timeFrame: Day +5
measure: Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
timeFrame: Day +10
measure: Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
timeFrame: Day +15
measure: Plasma PROS level compared to SARS-Cov-2 viral load
timeFrame: Day 0
measure: Plasma PROS level compared to SARS-Cov-2 viral load
timeFrame: Day+5
measure: Plasma PROS level compared to SARS-Cov-2 viral load
timeFrame: Day+10
measure: Plasma PROS level compared to SARS-Cov-2 viral load
timeFrame: Day+15
Secondary outcomes:
measure: Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related
timeFrame: Day 0, Day +5
measure: Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients.
timeFrame: Day 0, Day +5, Day +10, Day+15
measure: Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease
timeFrame: Day 0, Day +5, Day +10, Day+15
measure: Plasma protein S as an index for use of immunosuppressive therapy.
timeFrame: Day 0, Day +5, Day +10, Day+15
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: Lombardia
Study officials:
affiliation: San Gerardo Hospital
name: Luisa Verga, MD
role: STUDY_DIRECTOR
References: