COVID-19PROS-CovidNCT05351385
S Protein and COVID-19: a Monocentric Prospective Study
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hematolgy and Chemistry analysis, Real Time PCR and PROS assay COVID+
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2021to 3 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Pneumonia SARS-CoV-2 related or not related
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Gerardo Hospital
Monza, Lombardy, 20900
Luisa Verga, MD, +39 0392339868, l.verga@asst-monza.it
Daniela Ciulla, +39 0392339883, d.ciulla.hsg@gmail.com
About this study
The aim of this study is to compare plasma S Protein levels to SARS-CoV-2 viral load in COVID positive patients.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Hematolgy and Chemistry analysis, Real Time PCR, PROS assay COVID+, Sflt1 assay COVID+, PROS assay CONTROL
- Keywords
- PROS, S Protein, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematolgy and Chemistry analysisProcedure or surgery
Also called Peripheral Blood
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Real Time PCRProcedure or surgery
Also called Nasopharyngeal swab, Bronchoalveolar lavage
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROS assay COVID+Procedure or surgery
Also called Peripheral Blood
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Sflt1 assay COVID+Procedure or surgery
Also called Peripheral Blood
Samples will be collected at Day 0 and Day 10
PROS assay CONTROLProcedure or surgery
Also called Peripheral Blood
Samples will be collected at Day 0 (+5)
Sflt1 assay CONTROLProcedure or surgery
Also called Peripheral Blood
Samples will be collected at Day 0 (+5)
| Study group | Role | What they receive |
|---|---|---|
| Covid + | Patients SARS-CoV-2 positive. Receives: 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 Receives: Procedure: PROS assay CONTROL; Procedure: Sflt1 assay CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day+15
Secondary outcomes (4)
Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related
To confirm the non-consumption of protein S in Pneumonia other than SARS-CoV-2.
Measured: Day 0, Day +5
Normal levels Plasma S potein in late stage of SARS-CoV-2 infection in COVID + patients.
To confirm normalization of plasma S Potein levels longitudinally during the late stages of SARS-CoV-2 infection.
Measured: Day 0, Day +5, Day +10, Day+15
Correlation between plasma levels of S protein and the severity indices of SARS-CoV-2 disease
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).
Measured: Day 0, Day +5, Day +10, Day+15
Plasma protein S as an index for use of immunosuppressive therapy.
To use protein S values as an indicator for the introduction of immunosuppressive drugs in therapy in patients with COVID-19 disease.
Measured: Day 0, Day +5, Day +10, Day+15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start23 Sep 2021
- Primary completion3 Jun 2022
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- San Gerardo Hospital
- Responsible party
- Sponsor
- Investigators
- Luisa Verga, MD, Study director, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351385
- Sponsor's protocol ID
- PROS-Covid
- Acronym
- PROS-Covid
- Status last verified
- Dec 2023
- First submitted
- 5 Oct 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S Protein and COVID-19: a Monocentric Prospective Study
- ClinicalTrials.gov ID
- NCT05351385
- Acronym / sponsor ID
- PROS-Covid / PROS-Covid
- Conditions
- COVID-19
- Keywords
- PROS, S Protein, SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- San Gerardo Hospital
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid + | – | Procedure: Hematolgy and Chemistry analysis, Procedure: Real Time PCR, Procedure: PROS assay COVID+, Procedure: Sflt1 assay COVID+Patients SARS-CoV-2 positive. |
| Control | – | Procedure: PROS assay CONTROL, Procedure: Sflt1 assay CONTROLPatients with Pneumonia non-SARS-CoV-2 related |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Pneumonia SARS-CoV-2 related or not related
Key inclusion criteria (8 listed)
- Subjects aged ≥ 18 years.
- Signing of the informed consent.
- Positivity for SARS-CoV-2 by RealTimePCR from nasopharyngeal swab or bronchial wash.
- Subjects aged ≥ 18 years.
- Signing of the informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematolgy and Chemistry analysisAlso: Peripheral BloodSamples will be collected at Day 0, Day 5, Day 10 and Day 15 | Procedure or surgery | Covid + |
| Real Time PCRAlso: Nasopharyngeal swab, Bronchoalveolar lavageSamples will be collected at Day 0, Day 5, Day 10 and Day 15 | Procedure or surgery | Covid + |
| PROS assay COVID+Also: Peripheral BloodSamples will be collected at Day 0, Day 5, Day 10 and Day 15 | Procedure or surgery | Covid + |
| Sflt1 assay COVID+Also: Peripheral BloodSamples will be collected at Day 0 and Day 10 | Procedure or surgery | Covid + |
| PROS assay CONTROLAlso: Peripheral BloodSamples will be collected at Day 0 (+5) | Procedure or surgery | Control |
| Sflt1 assay CONTROLAlso: Peripheral BloodSamples will be collected at Day 0 (+5) | Procedure or surgery | Control |
Primary outcome
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.
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.
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.
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.
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
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
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
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
4 secondary outcomes
Normal plasma protein S levels in patients with Pneumonia non-SARS-CoV related
Time frame: 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
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
Plasma protein S as an index for use of immunosuppressive therapy.
Time frame: Day 0, Day +5, Day +10, Day+15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa Verga, MD study director
San Gerardo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Ciulla, M.Sc (+392339883, d.ciulla.hsg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma PROS levels compared to early stage of SARS-CoV-2 infection. (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.