S Protein and COVID-19: a Monocentric Prospective Study

NCT05351385 | Unknown

• 1 other identifier: PROS-Covid
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

PROS; S Protein; SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related

  Day 0, Day +5

• Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients.

  Day 0, Day +5, Day +10, Day+15

• Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease

  Day 0, Day +5, Day +10, Day+15

• Plasma protein S as an index for use of immunosuppressive therapy.

  Day 0, Day +5, Day +10, Day+15

Study Arms (2)

Covid +

Patients SARS-CoV-2 positive.

Procedure: Hematolgy and Chemistry analysis; Procedure: Real Time PCR; Procedure: PROS assay COVID+; Procedure: Sflt1 assay COVID+

Control

Patients with Pneumonia non-SARS-CoV-2 related

Procedure: PROS assay CONTROL; Procedure: Sflt1 assay CONTROL

Interventions

Hematolgy and Chemistry analysis PROCEDURE

Samples will be collected at Day 0, Day 5, Day 10 and Day 15

Also known as: Peripheral Blood

Covid +

Real Time PCR PROCEDURE

Samples will be collected at Day 0, Day 5, Day 10 and Day 15

Also known as: Nasopharyngeal swab, Bronchoalveolar lavage

Covid +

PROS assay COVID+ PROCEDURE

Samples will be collected at Day 0, Day 5, Day 10 and Day 15

Also known as: Peripheral Blood

Covid +

Sflt1 assay COVID+ PROCEDURE

Samples will be collected at Day 0 and Day 10

Also known as: Peripheral Blood

Covid +

PROS assay CONTROL PROCEDURE

Samples will be collected at Day 0 (+5)

Also known as: Peripheral Blood

Control

Sflt1 assay CONTROL PROCEDURE

Samples will be collected at Day 0 (+5)

Also known as: Peripheral Blood

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• Subjects aged ≥ 18 years.
• Signing of the informed consent.
• Diagnosis of pneumonia not related to SARS-CoV-2, demonstrated by negative swab.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• San Gerardo Hospital: collaborator

Study Sites (1)

San Gerardo Hospital

Monza, Lombardy, 20900, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab, Bronchoalveolar lavage, Peripheral blood

MeSH Terms

Conditions

COVID-19

Interventions

Real-Time Polymerase Chain Reaction; Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Therapeutic Irrigation

Study Officials

• Luisa Verga, MD

  San Gerardo Hospital

  STUDY DIRECTOR

Central Study Contacts

Daniela Ciulla, M.Sc

CONTACT

+392339883; d.ciulla.hsg@gmail.com

Ivan Civettini, MD

CONTACT

+39 039 2339883; ivan.civettini@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: April 28, 2022
• Study Start: September 23, 2021
• Primary Completion: June 3, 2022
• Study Completion: December 3, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)