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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    800
  • sponsor
    University of California, San Francisco
Updated on 5 April 2022
covid-19
SARS
coronavirus infection

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.

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.

Details
Condition COVID
Clinical Study IdentifierNCT04362150
SponsorUniversity of California, San Francisco
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent, and
Age >/= 18 years, and
A history of SARS-CoV-2 infection, as evidenced by
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
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

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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