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Biomarkers for Identification of COVID-19 Infection

NCT ID: NCT04322513

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-24

Study Completion Date

2022-12-30

Brief Summary

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Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.

Detailed Description

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Conditions

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Coronavirus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid-19 positive patients

all drugs used for standard treatment

Biomarkers expression

Intervention Type DIAGNOSTIC_TEST

Evaluation in biomarkers expression between 2 groups

Covid-19 negative patients

Biomarkers expression

Intervention Type DIAGNOSTIC_TEST

Evaluation in biomarkers expression between 2 groups

Interventions

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Biomarkers expression

Evaluation in biomarkers expression between 2 groups

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 75 years, extremes included, male or female In conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors.

Exclusion Criteria

* Patients that don't sign the informed consent
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Pugliese Ciaccio

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

OTHER

Sponsor Role collaborator

University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luca Gallelli

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luca Gallelli

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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LUCA GALLELLI

Role: CONTACT

[email protected]
3339245656 ext. 3339245656

Facility Contacts

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LUCA GALLELLI

Role: primary

[email protected]
3339245656 ext. 3339245656

Other Identifiers

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covid-19 biomarkers

Identifier Type: -

Identifier Source: org_study_id