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OpenTrials
Enrolling by Invitation

NCT Number: NCT05131594

Evaluating the Response of the Immune System of People with Long COVID (post SARS-CoV-2)

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.

Enrolling by Invitation

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Key information

Conditions

COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntington Hospital

Pasadena, California, 91105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From onset of infection to 60 months

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

Sponsors and collaborators

Lead sponsor

Huntington Memorial Hospital

Other

Collaborators

  • San Diego Biomedical Research Institute

Registry information

Official study title

Immune Response to Post Acute Sequelae of SARSCoV2: a Correlation of Clinical Symptoms and Inflammatory Pathways

Acronym: LCRC

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 23, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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