RECRUITING

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

Conditions

COVID COVID-19 coronavirus SARS-CoV-2 Long COVID post-acute sequelae of SARS-CoV-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-04-21

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04362150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Rebecca Hoh

CONTACT

415-476-4082 Ext. 139

rebecca.hoh@ucsf.edu

Michael J Peluso, MD

CONTACT

415-476-9363

michael.peluso@ucsf.edu

Principal Investigator

Steven Deeks, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Michael J Peluso, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Steven Deeks, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Michael J Peluso, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-21

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-04-21

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

COVID-19
coronavirus
SARS-CoV-2
Long COVID
post-acute sequelae of SARS-CoV-2

Additional Relevant MeSH Terms

COVID