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

NCT05131594 | Enrolling By Invitation

• 1 other identifier: Pro00054801
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

post-acute sequelae of SARS-CoV2; post-acute COVID-19 syndrome; long COVID

Outcome Measures

Primary Outcomes (5)

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

  Do patient symptoms correlate with abnormalities in inflammatory profiles?

  From onset of infection to 24 months

• Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays

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

  From onset of infection to 24 months

• Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection

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

  From onset of infection to 60 months

• Identification of risks factor for PASC

  What are the risk factors for PASC?

  From onset of infection to 24 months

• Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC

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

  From onset of infection to 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18 years old or older) who enroll in Huntington Hospital's Long Covid Recovery Clinic will be offered but are under no obligation to participate in this study. Subjects will have documented previous infection with SARS-CoV2 and 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).

You may qualify if:

• 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

You may not qualify if:

• No documented positive SARS-CoV2 serologies
• No post-acute sequelae of SARS-CoV2 symptomatology
• Incarcerated

Sponsors & Collaborators

• Huntington Memorial Hospital: lead
• San Diego Biomedical Research Institute: collaborator

Study Sites (1)

Huntington Hospital

Pasadena, California, 91105, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimberly Shriner, MD

  Huntington Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: November 23, 2021
• Study Start: October 13, 2021
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)