S Protein and COVID-19: a Monocentric Prospective Study (PROS-Covid)

December 29, 2023 updated by: University of Milano Bicocca
The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Monza, Lombardia, Italy, 20900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Pneumonia SARS-CoV-2 related or not related

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid +
Patients SARS-CoV-2 positive.
Procedure: Hematolgy and Chemistry analysis
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Names:
  • Peripheral Blood
Procedure: Real Time PCR
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Names:
  • Bronchoalveolar lavage
  • Nasopharyngeal swab
Procedure: PROS assay COVID+
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Other Names:
  • Peripheral Blood
Procedure: Sflt1 assay COVID+
Samples will be collected at Day 0 and Day 10
Other Names:
  • Peripheral Blood
Control
Patients with Pneumonia non-SARS-CoV-2 related
Procedure: PROS assay CONTROL
Samples will be collected at Day 0 (+5)
Other Names:
  • Peripheral Blood
Procedure: Sflt1 assay CONTROL
Samples will be collected at Day 0 (+5)
Other Names:
  • Peripheral Blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma PROS levels compared to early stage of SARS-CoV-2 infection.
Time Frame: Day 0
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.
Time Frame: Day +5
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.
Time Frame: Day +10
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.
Time Frame: Day +15
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
Time Frame: Day 0
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
Time Frame: Day+5
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
Time Frame: Day+10
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
Time Frame: Day+15
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
Time Frame: Day 0, Day +5
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.
Time Frame: Day 0, Day +5, Day +10, 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
Time Frame: Day 0, Day +5, Day +10, Day+15
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.
Time Frame: Day 0, Day +5, Day +10, Day+15
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Collaborators

San Gerardo Hospital

Investigators

  • Study Director: Luisa Verga, MD, San Gerardo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Actual)

June 3, 2022

Study Completion (Estimated)

December 3, 2024

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROS-Covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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