Immune Response to Post Acute Sequelae of SARSCoV2: A Correlation of Clinical Symptoms and Inflammatory Pathways
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Huntington Memorial Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)
Study Overview
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.
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
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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?
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?
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?
Identification of risks factor for PASC
Time Frame: From onset of infection to 24 months
What are the risk factors for PASC?
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?
Secondary Outcomes
No secondary outcomes reported