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

COVID Clinical Trial

— LIINC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04362150
• Other study ID #: 20-30479
• Status: Recruiting
• Start date: April 21, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Rebecca Hoh
• Phone: 415-476-4082 Ext. 139
• Email: rebecca.hoh[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital (ZSFG)	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant age	The median age of study participants at enrollment.	Baseline visit
Primary	Participant sex	The proportion of men and women participating in the baseline visit.	Baseline visit
Primary	Participant race/ethnicity	The proportion of participants from each demographic group.	Baseline visit
Primary	Proportion of participants previously hospitalized.	The proportion of participants who were previously hospitalized.	Baseline visit
Secondary	Long COVID Outcomes	The proportion of participants meeting various case definitions of Long COVID.	4, 8, 12, 16, 20, and 24 months post-COVID.

External Links

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