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LCRC: Evaluating the Response of the Immune System of People With Long COVID

Sponsor
Huntington Memorial Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05131594
Collaborator
San Diego Biomedical Research Institute (Other)
100
Enrollment
1
Location
31.6
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many people who have had COVID 19 continue to experience symptoms long after they have recovered from the acute infection. This study will examine the clinical symptoms of people with "Long COVID" and measure various markers of inflammation in their blood.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients who attend the Long Covid Recovery Clinic at Huntington Hospital will be offered participation in the study. After giving written informed consent, their medical history along with a description of clinical symptoms given through an extensive questionnaire will be accessed. Venous blood will be collected as a baseline and then at follow up visits (as dictated by changes in clinical symptomatology) for evaluation of corollary immune parameters. Patients will be followed at a minimum of every 2 months for 2 years.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immune Response to Post Acute Sequelae of SARSCoV2: A Correlation of Clinical Symptoms and Inflammatory Pathways
    Actual Study Start Date :
    Oct 13, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC) [From onset of infection to 24 months]

      Do patient symptoms correlate with abnormalities in inflammatory profiles?

    2. Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays [From onset of infection to 24 months]

      Are there abnormalities in immunologic and inflammatory assays unique to PASC?

    3. Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection [From onset of infection to 60 months]

      What are the pathological pathways and long-term effects of SARS-CoV2?

    4. Identification of risks factor for PASC [From onset of infection to 24 months]

      What are the risk factors for PASC?

    5. Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC [From onset of infection to 60 months]

      Are there potential sites of therapeutic intervention to relieve the symptoms of PASC?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Enrolled in Huntington Hospital's Long Covid Recovery Clinic

    • Documented previous infection with SARS-CoV2

    • Symptoms suggestive of post-acute sequelae of SARS-CoV2 (including but not limited to chronic fatigue, brain fog, muscle and joint pain, cardiac and pulmonary issues, or other factors related to their acute COVID-19 event)

    • Signed Informed Consent Form

    Exclusion Criteria:

    • No documented positive SARS-CoV2 serologies

    • No post-acute sequelae of SARS-CoV2 symptomatology

    • Incarcerated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huntington Hospital Pasadena California United States 91105

    Sponsors and Collaborators

    • Huntington Memorial Hospital
    • San Diego Biomedical Research Institute

    Investigators

    • Principal Investigator: Kimberly Shriner, MD, Huntington Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huntington Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05131594
    Other Study ID Numbers:
    • Pro00054801
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huntington Memorial Hospital
    post-acute sequelae of SARS-CoV2
    post-acute COVID-19 syndrome
    long COVID
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 23, 2021