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NCT Number: NCT04362150

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Emily A Fehrman, MPH

CONTACT

[email protected]

(650) 761-2163

Michael J Peluso, MD

CONTACT

[email protected]

415-476-4082 x 119

Steven G Deeks, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily A Fehrman, MPH

CONTACT

[email protected]

(650) 761-2163

Michael J Peluso, MD

CONTACT

[email protected]

415-476-9363

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study

Acronym: LIINC

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Apr 24, 2020
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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