S Protein and COVID-19: a Monocentric Prospective Study

COVID-19 Clinical Trial

— PROS-Covid  

Official title:

S Protein and COVID-19: a Monocentric Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351385
• Other study ID #: PROS-Covid
• Status: Recruiting
• Start date: September 23, 2021
• Est. completion date: December 3, 2024

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: Daniela Ciulla, M.Sc
• Phone: +392339883
• Email: d.ciulla.hsg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 3, 2024
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Hematolgy and Chemistry analysis
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
• Real Time PCR
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
• PROS assay COVID+
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
• Sflt1 assay COVID+
Samples will be collected at Day 0 and Day 10
• PROS assay CONTROL
Samples will be collected at Day 0 (+5)
• Sflt1 assay CONTROL
Samples will be collected at Day 0 (+5)

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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