The purpose of this study is to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection.
Participants will provide health information and biological samples, such as blood, saliva, stool, and, for some participants, tissue biopsies. These samples will be used to study the biological processes involved in Long COVID and to support the development of new diagnostic tests that may improve future research, clinical trials, and patient care.
Willing and able to provide written informed consent, and
Age >/= 18 years, and
Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC).
Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols.
Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
The study population will include adults with well-characterized Long COVID and adults who have recovered following SARS-CoV-2 infection. Participants will be enrolled from the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC) research program and through community outreach and referral efforts. The study aims to include individuals with a range of Long COVID symptom patterns and durations to support research on the biological mechanisms of the condition.
Cohort
Prospective
Not listed
Participant age
The median age of study participants at enrollment
Participant sex
The proportion of men and women participating in the baseline visit.
Participant race/ethnicity
The proportion of participants from each demographic group
Proportion of participants previously hospitalized
The proportion of participants who were previously hospitalized
Protocol complete
The proportion of enrolled participants who complete all study activities
Long COVID Symptom Assessment
Participant-reported assessment for presence and severity of persistent post-COVID-19 symptoms
Qualify of Life Assessment (Global Health Score)
Measure of overall health-related quality of life
Mental Health Symptom Assessment
An instrument such as the PHQ-9 will be used to assess participants' overall mental health status. These will include questions about anxiety and depression, independent of Long COVID association.
Cognitive Symptom Assessment
An instrument such as the Everyday Cognition survey will be used to asses perceived changes in everyday cognitive function across domains compared to participants' pre-COVID baselines.
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University of California, San Francisco
Lead sponsor
PolyBio Research Foundation
Collaborator
