INFLAMmatory BiomarkErs in COVID-19 Participants and Severity of Disease

NCT05175846 | Unknown

• 1 other identifier: 001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Observational Study of the Association of Immunological and Inflammatory Biomarkers in COVID-19 Naïve and Infected Participants and Severity of Disease. Thirty naive and 30 COVID positive participants will have a blood sample taken after informed consent and be assessed for COVID symptoms according to WHO classification. Participants will be followed monthly for 6 months. At each contact, participants will be assessed for COVID symptoms and progress since the previous visit.

Conditions

COVID-19

Keywords

COVID-19, inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• To identify immunological and inflammatory biomarkers in participants with and without COVID-19 that may predict a participant's potential risk for severity of disease.

  Correlation of biomarkers at baseline with severity of COVID-19 disease at baseline and on Day 30 according to WHO classification of COVID-19 symptoms

  30 days

Secondary Outcomes (1)

• To correlate the biomarkers at baseline with the duration of symptoms up to six months in participants who develop COVID-19.

  6 months

Study Arms (2)

Normal volunteers

Participants with negative COVID-19 test

COVID-19

Participants with positive COVID-19 test and severe symptoms of disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants at least 18 years of age who do not have autoimmune disease or are not taking immune-modulator therapy and may or may not have a positive COVID-19 test will be entered into one of two groups for Stage 1 of the study. (Stage 2 is TBD). * Group 1: Participants whose COVID-19 test is negative and who do not have symptoms of COVID-19 disease. * Group 2: Participants whose COVID-19 test is positive and who have Severe or Critical symptoms of COVID-19 disease

You may qualify if:

• Signed informed consent (IC) within 4 days of COVID-19 test.
• Age 18 or older
• COVID-19 test
• Group 1: negative COVID-19 test Group 2: positive COVID-19 test with Severe or Critical symptoms of disease (per WHO Guidance).

You may not qualify if:

• Any autoimmune disease or immune-modulator therapy.
• Mild or Moderate symptoms of COVID-19 disease (per WHO Guidance).

Sponsors & Collaborators

• Trinitas Global, LLC: lead
• AccessDx Laboratories, Houston, TX: collaborator

Study Sites (1)

St Francis Hospital

Wilmington, Delaware, 19805, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma collected for testing of inflammatory biomarkers

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert A Monteleone, MD

  Saint Francis Family Medicine Residency Program, Wilmington, Delaware

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn G Project Manager

CONTACT

206 890 2710; lynngallen@live.com

Angela Study Coordinator

CONTACT

302 547 0820

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 4, 2022
• Study Start: April 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)