Role of Children in Transmission of COVID-19 to Immunocompromised Patients

Terminated

• Conditions: Immunosuppression

• Registration Number: NCT04407546
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

This is a study of immunosuppressed individuals living in households with and without children to assess the role of household contact with children in the transmission of SARSCoV-2 to immunocompromised individuals. Through careful collection of epidemiological data in combination with biological specimens, risk factors for SARS-CoV-2 in immunocompromised individuals will be identified. During the initial visits, informed consent will be obtained and consented participants will complete an initial questionnaire and provide biological specimens including nasal swabs, saliva and blood. Thereafter, participants will complete at-home saliva collections and questionnaires on a weekly basis for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be referred immediately for medical attention and will be followed every 3 days with nasal swabs and saliva samples and weekly blood specimens and optional rectal swabs or fresh stool collection. Additionally, participants will be contacted by telephone at 1 year for follow-up.

Detailed Description

This is a prospective, longitudinal cohort study of immunosuppressed patients living in households with and without children to assess the role of household contact with children in the transmission of SARS-CoV-2 to immunocompromised patients. This study will be enrolling both pediatric and adult patients who are immunosuppressed, as well as their household members who agree to participate. Through careful collection of epidemiological data in combination with biological specimens, risk factors for SARS- CoV-2 in immunocompromised patients will be identified. During the initial study visit, informed consent will be obtained, the study questionnaire will be completed and the participant will provide biological specimens including nasal mid-turbinate swabs, saliva and blood. Thereafter, participants will complete at-home saliva collections and questionnaires on a weekly basis for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be referred immediately to University of California at Los Angeles(UCLA) Health for medical attention and will be followed every 3 days with nasal swabs and saliva samples, and weekly blood specimens and optional rectal swabs or fresh stool collection. Biological specimen and questionnaire follow-up will occur for 6 months for uninfected participants or until the of end of viral shedding and immunologic profiling for patients infected with SARS-CoV-2, whichever is longer. All participants will be followed at 6 months with the same baseline measurements and then participants will be contacted by telephone at 1 year.

The clinical data and biological specimens collected in this initial study will provide will inform and allow future studies of clinical outcomes, viral characteristics, and immune responses to SARS-CoV-2 infection.

Study Timeline

• Study Start: 2020-05-27
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Status Verified: 2023-03
• Primary Completion: 2023-03-13
• Study Completion: 2023-03-13
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Immunocompromised patient followed at UCLA Health
• Immunocompromised patient >1 day old to <60 years of age
• Patient with a diagnosis of breast, lung, or colorectal cancers, lymphoma, acute/chronic leukemia, multiple myeloma, or other solid tumors and are receiving chemotherapy
• Patients who have received a hematopoietic stem cell transplantation within the last year
• Patients who have received a solid organ transplantation within the last year

Exclusion Criteria

• Immunocompromised patients with positive SARS-CoV-2 test prior to study enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To define the role of household contact with children or siblings in the transmission of SARS-CoV-2 to immunocompromised patients.	up to one year	Measure the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children

Secondary Outcome Measures

Name	Time	Method
To characterize secondary cases of SARS-CoV-2 in immunocompromised participants	up to one year	Measure the rate of serology conversion of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children
To describe the exposure factors such as pets and travel and how those factors are related to immunocompromised patients to estimate risk profiles by household characteristics	up to one year	Measure the rates of exposures to the following risk factors: persons with positive SARS-CoV-2 PCR test, pets, previous travel to the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children.

Trial Locations

Locations (1)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States