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

• ClinicalTrials.gov Identifier: NCT04322513
• Recruitment Status: Recruiting
• First Posted: March 26, 2020
• Last Update Posted: October 25, 2021
• Sponsor: University of Catanzaro
• 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

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

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

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