COVID-19
Conditions
Keywords
PROS, S Protein, SARS-CoV-2, COVID-19
Brief summary
The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.
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.
Interventions
PROCEDUREHematolgy and Chemistry analysis
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROCEDUREReal Time PCR
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROCEDUREPROS assay COVID+
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROCEDURESflt1 assay COVID+
Samples will be collected at Day 0 and Day 10
PROCEDUREPROS assay CONTROL
Samples will be collected at Day 0 (+5)
PROCEDURESflt1 assay CONTROL
Samples will be collected at Day 0 (+5)
Sponsors
San Gerardo Hospital
University of Milano Bicocca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PROS levels compared to early stage of SARS-CoV-2 infection. | 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. |
| Plasma PROS level compared to SARS-Cov-2 viral load | Day 0 | To demonstrate a correlation between PROS and the viral load of SARS-CoV-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related | Day 0, Day +5 | To confirm the non-consumption of protein S in Pneumonia other than SARS-CoV-2. |
| Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients. | 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. |
| Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease | 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). |
| Plasma protein S as an index for use of immunosuppressive therapy. | 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. |
Countries
Italy
Contacts
Primary ContactDaniela Ciulla, M.Sc
Backup ContactIvan Civettini, MD
Outcome results
None listed