Biomarkers for Identification of COVID-19 Infection
B-DT-COV2
Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection
1 other identifier
observational
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedStudy Start
First participant enrolled
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 25, 2021
October 1, 2021
1.3 years
March 23, 2020
October 15, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment
60 days
Study Arms (2)
Covid-19 positive patients
all drugs used for standard treatment
Covid-19 negative patients
Interventions
Evaluation in biomarkers expression between 2 groups
Eligibility Criteria
Patients of both sexes and \> 18 years with and without covid-19 infection that came in hospital for flu-like syptoms: cough fever and dyspnea
You may qualify if:
- 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.
You may not qualify if:
- Patients that don't sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luca Gallelli
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 26, 2020
Study Start
March 24, 2020
Primary Completion
June 30, 2021
Study Completion
December 30, 2022
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share