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

NCT04362150 | Recruiting

• 1 other identifier: 20-30479
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

COVID-19; coronavirus; SARS-CoV-2; Long COVID; post-acute sequelae of SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• Participant age

  The median age of study participants at enrollment.

  Baseline visit

• Participant sex

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

  Baseline visit

• Participant race/ethnicity

  The proportion of participants from each demographic group.

  Baseline visit

• Proportion of participants previously hospitalized.

  The proportion of participants who were previously hospitalized.

  Baseline visit

Secondary Outcomes (1)

• Long COVID Outcomes

  4, 8, 12, 16, 20, and 24 months post-COVID.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36454631 DERIVED

Related Links

• Long-term Impact of Infection with Novel Coronavirus study website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, peripheral blood mononuclear cells, plasma, serum, and saliva.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Deeks, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Michael J Peluso, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Hoh

CONTACT

415-476-4082 Ext. 139; rebecca.hoh@ucsf.edu

Michael J Peluso, MD

CONTACT

415-476-9363; michael.peluso@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 24, 2020
• Study Start: April 21, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)