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

NCT ID: NCT04362150

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2030-12-31

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.

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.

Conditions

COVID

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Deeks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Michael J Peluso, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Hoh

Role: CONTACT

rebecca.hoh@ucsf.edu

415-476-4082 Ext. 139

Michael J Peluso, MD

Role: CONTACT

michael.peluso@ucsf.edu

415-476-9363

Facility Contacts

Michael J Peluso, MD

Role: primary

michael.peluso@ucsf.edu

415-476-4082 x 119

Rebecca Hoh

Role: backup

Rebecca.Hoh@ucsf.edu

415-476-4082 x 135 ext. 139

References

Peluso MJ, Deveau TM, Munter SE, Ryder D, Buck A, Beck-Engeser G, Chan F, Lu S, Goldberg SA, Hoh R, Tai V, Torres L, Iyer NS, Deswal M, Ngo LH, Buitrago M, Rodriguez A, Chen JY, Yee BC, Chenna A, Winslow JW, Petropoulos CJ, Deitchman AN, Hellmuth J, Spinelli MA, Durstenfeld MS, Hsue PY, Kelly JD, Martin JN, Deeks SG, Hunt PW, Henrich TJ. Chronic viral coinfections differentially affect the likelihood of developing long COVID. J Clin Invest. 2023 Feb 1;133(3):e163669. doi: 10.1172/JCI163669.

Reference Type: DERIVED

PMID: 36454631 (View on PubMed)

Related Links

https://www.liincstudy.org/en/home

Long-term Impact of Infection with Novel Coronavirus study website

Other Identifiers

20-30479

Identifier Type: -

Identifier Source: org_study_id