Coronavirus Clinical Trial
— B-DT-COV2Official title:
Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 30, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Luca Gallelli | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University of Catanzaro | Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biomarkers expression | Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients | up to 30 days | |
Primary | Liver Biomarkers expression | Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy | up to 30 days | |
Secondary | biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment | Changes in biomarkers in covid-19 patients before and after standard treatment | 60 days |
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