Long-term Impact of Infection With Novel Coronavirus (COVID-19)
ConditionCOVID
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of California, San Francisco
About this trial
LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide written informed consent, and
Age >/= 18 years, and
Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or
Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,
Disqualifiers
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.
Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements or to give informed consent.
Trial population
The investigators will enroll individuals with prior SARS-CoV-2 infection across a wide spectrum of age, race, gender, and disease severity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 1 trial groupGroup A: COVID-19 positive, recovered
Trial outcomes
Primary outcomes
1
Participant age
The median age of study participants at enrollment.
Time frame
Baseline visit2
Participant sex
The proportion of men and women participating in the baseline visit.
Time frame
Baseline visit3
Participant race/ethnicity
The proportion of participants from each demographic group.
Time frame
Baseline visit4
Proportion of participants previously hospitalized.
The proportion of participants who were previously hospitalized.
Time frame
Baseline visitSecondary outcomes
1
Long COVID Outcomes
The proportion of participants meeting various case definitions of Long COVID.
Time frame
4, 8, 12, 16, 20, and 24 months post-COVID.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov