Biomarkers for Identification of COVID-19 Infection

Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04322513

Acronym

B-DT-COV2

Enrollment

110

Registered

2020-03-26

Start date

2020-03-24

Completion date

2022-12-30

Last updated

2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBiomarkers expression

Evaluation in biomarkers expression between 2 groups

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers expression	up to 30 days	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
Liver Biomarkers expression	up to 30 days	Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Secondary

Measure	Time frame	Description
biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment	60 days	Changes in biomarkers in covid-19 patients before and after standard treatment

Countries

Italy

Contacts

Primary ContactLUCA GALLELLI

gallelli@unicz.it3339245656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026