Clinical trial NCT05131594: Evaluating the Response of the Immune System of People with Long COVID (post SARS-CoV-2)
Official title: Immune Response to Post Acute Sequelae of SARSCoV2: a Correlation of Clinical Symptoms and Inflammatory Pathways
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Keywords: post-acute sequelae of SARS-CoV2
post-acute COVID-19 syndrome
long COVID
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
Collaborators: name: San Diego Biomedical Research Institute
First posted: 2021-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* Enrolled in Huntington Hospital\&#39;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

Primary outcomes:
measure: Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)
timeFrame: From onset of infection to 24 months
measure: Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays
timeFrame: From onset of infection to 24 months
measure: Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection
timeFrame: From onset of infection to 60 months
measure: Identification of risks factor for PASC
timeFrame: From onset of infection to 24 months
measure: Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC
timeFrame: From onset of infection to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Hospital
state: California
Study officials:
affiliation: Huntington Hospital
name: Kimberly Shriner, MD
role: PRINCIPAL_INVESTIGATOR
References: