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Biomarkers for Identification of COVID-19 Infection (B-DT-COV2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322513
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : October 25, 2021
Sponsor:
Collaborators:
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Information provided by (Responsible Party):
Luca Gallelli, University of Catanzaro

Tracking Information
First Submitted Date March 23, 2020
First Posted Date March 26, 2020
Last Update Posted Date October 25, 2021
Actual Study Start Date March 24, 2020
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2020)
  • Biomarkers expression [ Time Frame: 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 [ Time Frame: up to 30 days ]
    Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy
Original Primary Outcome Measures
 (submitted: March 23, 2020)
  • Biomarkers expression [ Time Frame: up to 30 days ]
    Change in biomarkers (microRNA, oxidative stress, cytokines) in covid-19 positive patients vs covid-negative patients
  • Liver Biomarkers expression [ Time Frame: up to 30 days ]
    Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy
Change History
Current Secondary Outcome Measures
 (submitted: May 4, 2020)
biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment [ Time Frame: 60 days ]
Changes in biomarkers in covid-19 patients before and after standard treatment
Original Secondary Outcome Measures
 (submitted: March 23, 2020)
biomarkers expression after treatment [ Time Frame: 60 days ]
Changes in biomarkers in covid-19 patients before and after standard treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers for Identification of COVID-19 Infection
Official Title Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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
Condition Coronavirus
Intervention Diagnostic Test: Biomarkers expression
Evaluation in biomarkers expression between 2 groups
Study Groups/Cohorts
  • Covid-19 positive patients
    all drugs used for standard treatment
    Intervention: Diagnostic Test: Biomarkers expression
  • Covid-19 negative patients
    Intervention: Diagnostic Test: Biomarkers expression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 23, 2020)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: LUCA GALLELLI 3339245656 ext 3339245656 gallelli@unicz.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04322513
Other Study ID Numbers covid-19 biomarkers
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Luca Gallelli, University of Catanzaro
Original Responsible Party Luca Gallelli, University of Catanzaro, Prof
Current Study Sponsor University of Catanzaro
Original Study Sponsor Same as current
Collaborators
  • Azienda Ospedaliera Pugliese Ciaccio
  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Investigators Not Provided
PRS Account University of Catanzaro
Verification Date October 2021