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

U

University of Milano Bicocca

Status

Enrolling

Conditions

COVID-19

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05351385
PROS-Covid

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

Covid +
Description:
Patients SARS-CoV-2 positive.
Treatment:
Procedure: PROS assay COVID+
Procedure: Sflt1 assay COVID+
Procedure: Hematolgy and Chemistry analysis
Procedure: Real Time PCR
Control
Description:
Patients with Pneumonia non-SARS-CoV-2 related
Treatment:
Procedure: PROS assay CONTROL
Procedure: Sflt1 assay CONTROL

Trial contacts and locations

1

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Central trial contact

Ivan Civettini, MD; Daniela Ciulla, M.Sc

Data sourced from clinicaltrials.gov

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