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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Milano Bicocca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Gerardo Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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