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

• Conditions: COVID-19

• Registration Number: NCT05131594
• Lead Sponsor: Huntington Memorial Hospital

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 Timeline

• Study Start: 2021-10-13
• Status Verified: 2021-11
• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?
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?
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?
Identification of risks factor for PASC	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	From onset of infection to 60 months	Are there potential sites of therapeutic intervention to relieve the symptoms of PASC?

Trial Locations

Locations (1)

Huntington Hospital; 🇺🇸 Pasadena, California, United States