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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362150
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

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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, 2022
Estimated Study Completion Date : December 21, 2024

Resource links provided by the National Library of Medicine


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).



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.


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


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.

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


Locations
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United States, California
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Steven Deeks, MD University of California, San Francisco
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: November 18, 2020
Last Verified: November 2020
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
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases