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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362150
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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
COVID

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
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Study Type : Observational
Estimated 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 : April 21, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Participant age [ Time Frame: Baseline visit ]
    The median age of study participants at enrollment.

  2. Participant sex [ Time Frame: Baseline visit ]
    The proportion of men and women participating in the baseline visit.

  3. Participant race/ethnicity [ Time Frame: Baseline visit ]
    The proportion of participants from each demographic group.

  4. Proportion of participants previously hospitalized. [ Time Frame: Baseline visit ]
    The proportion of participants who were previously hospitalized.


Secondary Outcome Measures :
  1. Long COVID Outcomes [ Time Frame: 4, 8, 12, 16, 20, and 24 months post-COVID. ]
    The proportion of participants meeting various case definitions of Long COVID.


Biospecimen Retention:   Samples With DNA
Whole blood, peripheral blood mononuclear cells, plasma, serum, and saliva.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will enroll individuals with prior SARS-CoV-2 infection across a wide spectrum of age, race, gender, and disease severity.
Criteria

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:

    1. Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or
    2. 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,
  4. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362150


Contacts
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Contact: Rebecca Hoh 415-476-4082 Ext. 139 rebecca.hoh@ucsf.edu
Contact: Michael J Peluso, MD 415-476-9363 michael.peluso@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital (ZSFG) Recruiting
San Francisco, California, United States, 94110
Contact: Michael J Peluso, MD    415-476-4082 x 119    michael.peluso@ucsf.edu   
Contact: Rebecca Hoh    415-476-4082 x 135 ext 139    Rebecca.Hoh@ucsf.edu   
Principal Investigator: Steven G Deeks, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Steven Deeks, MD University of California, San Francisco
Principal Investigator: Michael J Peluso, MD University of California, San Francisco
More Information
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Additional Information:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04362150    
Other Study ID Numbers: 20-30479
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Long COVID
post-acute sequelae of SARS-CoV-2
Additional relevant MeSH terms:
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Coronavirus Infections
Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases