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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362150
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date April 23, 2020
First Posted Date April 24, 2020
Last Update Posted Date November 18, 2020
Actual Study Start Date April 21, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2020)
  • Participant age [ Time Frame: Baseline visit ]
    The median age of study participants at enrollment.
  • Participant sex [ Time Frame: Baseline visit ]
    The proportion of men and women participating in the baseline visit.
  • Participant race/ethnicity [ Time Frame: Baseline visit ]
    The proportion of participants from each demographic group.
  • Proportion of participants previously hospitalized. [ Time Frame: Baseline visit ]
    The proportion of participants who were previously hospitalized.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Impact of Infection With Novel Coronavirus (COVID-19)
Official Title Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, peripheral blood mononuclear cells, plasma, serum, and saliva.
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.
Condition COVID
Intervention Not Provided
Study Groups/Cohorts 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 23, 2020)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 21, 2024
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04362150
Other Study ID Numbers 20-30479
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Steven Deeks, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2020