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

a study on COVID-19

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Steven Deeks, MDMichael J Peluso, MD
Headshot of Steven Deeks
Steven Deeks
Headshot of Michael J Peluso
Michael J Peluso

Description

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.

Official Title

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

Details

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.

Keywords

COVID, COVID-19, coronavirus, SARS-CoV-2, Long COVID, post-acute sequelae of SARS-CoV-2, Coronavirus Infections, COVID-19 positive, recovered

Eligibility

You can join if…

Open to people ages 18-100

  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.

You CAN'T join if...

  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.

Location

  • Zuckerberg San Francisco General Hospital (ZSFG) accepting new patients
    San Francisco California 94110 United States

Lead Scientists at UCSF

  • Steven Deeks, MD
    Steven G. Deeks, MD, is a Professor of Medicine in Residence at the University of California, San Francisco (UCSF) and a faculty member in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital. He is an internationally recognized expert on HIV pathogenesis and treatment.
  • Michael J Peluso, MD
    I am an infectious disease clinician and researcher. My primary interests are HIV cure and Long COVID. For HIV, I am involved with clinical and laboratory research aimed at understanding the HIV reservoir and implementing clinical trials to disrupt the reservoir with the aim of inducing antiretroviral therapy-free HIV remission.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Long-term Impact of Infection with Novel Coronavirus study website
ID
NCT04362150
Study Type
Observational
Participants
Expecting 800 study participants
Last Updated
Contact us about this trial