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INFLAMmatory BiomarkErs in COVID-19 Participants and Severity of Disease (INFLAME COVID)

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: NCT05175846
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
AccessDx Laboratories, Houston, TX
Information provided by (Responsible Party):
Trinitas Global, LLC

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.

Condition or disease
COVID-19

Detailed Description:

This is an observational study of participants who are being or have been tested for COVID-19. Participants with or without COVID-19 will be entered into one of two groups for Stage 1 and one of three groups for Stage 2.

Stage 1:

  • 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.

Stage 2:

  • 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 Mild or Moderate symptoms of COVID-19 disease.
  • Group 3: Participants whose COVID-19 test is positive and who have Severe or Critical symptoms of COVID-19 disease.

During Stage 1, Group 1 participants will be matched to Group 2 subjects as follows: Age: 18-64 and >65; Race: Caucasian, Latino, African American, other; Sex: Male or Female Each participant will be assigned a study number. The study case report form (CRF) will record the participants initials, age and study number. Participants will have blood drawn for biomarkers. All samples will be identified using the participants age and study number. Blood volume will be approximately ten milliliters to yield at least four 1 ml serum aliquots. Serum will be frozen at -80ºF and stored. Batch shipments of the serum will occur during the study and sent to AccessDx Laboratory in Houston TX. Laboratory procedures for AccessDx are presented in Appendices B and C. AccessDx will perform the following biomarker tests on the serum: Interleukins 1B, 6, 8,10, 22; CRP; Ferritin; Interferon-ꝩ; MIP 1α and 1β; TNF; VEGF A, B, C.

Participants will be followed for up to 6 months and have monthly calls from the study staff. As much as possible, the participant will be contacted by the same study member at each follow-up visit. If agreed with the participant, information about the participants status may be collected on email or text. Participants will be asked specific questions and their responses recorded on a paper CRF. At enrollment and at each follow-up call, the participant's severity of COVID-19 disease will be categorized based on WHO Interim guidance 27 May 2020 as follows:

  • Mild cases are marked by the onset of symptoms such as fever, cough, fatigue, shortness of breath, headache, diarrhea, and so forth, without evidence of viral pneumonia or hypoxia.
  • Moderate cases include clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air.
  • Severe cases demonstrate clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) plus one of the following: respiratory rate > 30 breaths/min; severe respiratory distress; or SpO2 < 90% on room air.
  • Critical cases present symptoms such as acute respiratory distress syndrome (ARDS), sepsis and/or septic shock A participant's engagement in the study will be approximately 6 months. Recruitment is expected to last 6 months. It is expected that the total study for Stage 1 will be one year. The duration of Stage 2 will not be determined until results from Stage 1 are available. The number of investigator sites for Stage 1 is expected to be up to 3 and for Stage 2, up to 50.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Immunological and INFLAMmatory BiomarkErs in COVID-19 Naïve and Infected Participants and Severity of Disease
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Normal volunteers
Participants with negative COVID-19 test
COVID-19
Participants with positive COVID-19 test and severe symptoms of disease



Primary Outcome Measures :
  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. [ Time Frame: 30 days ]
    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


Secondary Outcome Measures :
  1. To correlate the biomarkers at baseline with the duration of symptoms up to six months in participants who develop COVID-19. [ Time Frame: 6 months ]
    Duration and severity of symptoms of COVID-19


Biospecimen Retention:   Samples Without DNA
plasma collected for testing of inflammatory biomarkers


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05175846


Contacts
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Contact: Lynn G Project Manager 206 890 2710 lynngallen@live.com
Contact: Angela Study Coordinator 302 547 0820

Locations
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United States, Delaware
St Francis Hospital Recruiting
Wilmington, Delaware, United States, 19805
Contact: Angela Herman, DNP, RN    302-547-0820    angela.herman@che-east.org   
Principal Investigator: Robert A Monteleone, MD         
Sponsors and Collaborators
Trinitas Global, LLC
AccessDx Laboratories, Houston, TX
Investigators
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Principal Investigator: Robert A Monteleone, MD Saint Francis Family Medicine Residency Program, Wilmington, Delaware
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Responsible Party: Trinitas Global, LLC
ClinicalTrials.gov Identifier: NCT05175846    
Other Study ID Numbers: 001
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trinitas Global, LLC:
COVID-19, inflammatory biomarkers
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases