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

COVID-19 Clinical Trial

— LCRC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05131594
• Other study ID #: Pro00054801
• Status: Enrolling by invitation
• Start date: October 13, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2021
• Source: Huntington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United States	Huntington Hospital	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Huntington Memorial Hospital	San Diego Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Identification of risks factor for PASC	What are the risk factors for PASC?	From onset of infection to 24 months
Primary	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