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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04362150|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 19, 2023
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|Condition or disease|
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|
|Estimated Enrollment :||800 participants|
|Official Title:||Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study|
|Actual Study Start Date :||April 21, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
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).
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362150
|Contact: Rebecca Hoh||415-476-4082 Ext. firstname.lastname@example.org|
|Contact: Michael J Peluso, MDemail@example.com|
|United States, California|
|Zuckerberg San Francisco General Hospital (ZSFG)||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Michael J Peluso, MD 415-476-4082 x 119 firstname.lastname@example.org|
|Contact: Rebecca Hoh 415-476-4082 x 135 ext 139 Rebecca.Hoh@ucsf.edu|
|Principal Investigator: Steven G Deeks, MD|
|Principal Investigator:||Steven Deeks, MD||University of California, San Francisco|
|Principal Investigator:||Michael J Peluso, MD||University of California, San Francisco|
|Responsible Party:||University of California, San Francisco|
|Other Study ID Numbers:||
|First Posted:||April 24, 2020 Key Record Dates|
|Last Update Posted:||April 19, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
post-acute sequelae of SARS-CoV-2
RNA Virus Infections