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LIINC: Long-term Impact of Infection With Novel Coronavirus (COVID-19)

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04362150
Collaborator
(none)
800
Enrollment
1
Location
32.3
Anticipated Duration (Months)
24.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    LIINC is an observational, prospective study of individuals previously infected with SARS-CoV-2 who have recovered from acute illness. The overall objective of the study is to investigate the clinical consequences of SARS-CoV-2 infection. These include the pre-existence and development of medical conditions, measures of immune activation and inflammation, changes in immunologic function, and variability in host responses. There will be a specific focus on demographic differences including age, gender, and race.

    Enrolled volunteers are seen at San Francisco General Hospital at baseline, monthly for 3 months and then every 3 months for up to 2 years. Visits include a detailed interview, saliva collection, and a blood draw. Baseline visits take approximately 90 minutes, and follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study
    Actual Study Start Date :
    Apr 21, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    COVID-19 positive, recovered

    Individuals with positive test for COVID-19 who have recovered from acute infection (21 days after symptom onset + improvement in symptoms + resolution of fever for 72 hours without fever reducing medicines).

    Outcome Measures

    Primary Outcome Measures

    1. Participant age [Baseline visit]

      The median age of study participants at enrollment.

    2. Participant sex [Baseline visit]

      The proportion of men and women participating in the baseline visit.

    3. Participant race/ethnicity [Baseline visit]

      The proportion of participants from each demographic group.

    4. Proportion of participants previously hospitalized. [Baseline visit]

      The proportion of participants who were previously hospitalized.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Willing and able to provide written informed consent, and

    2. Age >/= 18 years, and

    3. A history of SARS-CoV-2 infection, as evidenced by:

    4. Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or

    5. 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,

    6. And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier.

    Exclusion Criteria:

    1. Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.

    2. 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.

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zuckerberg San Francisco General Hospital (ZSFG) San Francisco California United States 94110

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Steven Deeks, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04362150
    Other Study ID Numbers:
    • 20-30479
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    COVID-19
    coronavirus
    SARS-CoV-2
    Additional relevant MeSH terms:
    Coronavirus Infections

    Study Results

    No Results Posted as of Mar 24, 2022