Recruiting

Observational Study

Sponsor:

Trinitas Global, LLC

Code:

NCT05175846

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05175846

Start date

Apr 1, 2022

Status verified date

Jan, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jan 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent (IC) within 4 days of COVID-19 test.
2. Age 18 or older
3. 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).

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal volunteers

Participants with negative COVID-19 test

COVID-19

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

Primary outcome measure

  • 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. [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Lynn G Project Manager

206 890 2710lynngallen@live.com

Angela Study Coordinator

302 547 0820

Locations

St Francis Hospital

Recruiting

Wilmington, Delaware, United States, 19805

Contacts

Angela Herman, DNP, RN

302-547-0820angela.herman@che-east.org

Principal Investigator:

Robert A Monteleone, MD

More Information

Sponsor

Trinitas Global, LLC

Last update posted

Jun 1, 2022

Last verified

Jan, 2022

Keywords

  • COVID-19, inflammatory biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Trinitas Global, LLC on 2022-06-01.