Role of Children in Transmission of COVID-19 to Immunocompromised Patients
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|ClinicalTrials.gov Identifier: NCT04407546|
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : July 23, 2020
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Role of Children in the Transmission of SARS-CoV-2 in Households of Immunocompromised Persons|
|Actual Study Start Date :||May 27, 2020|
|Estimated Primary Completion Date :||May 28, 2022|
|Estimated Study Completion Date :||May 28, 2023|
Families with Children
Families containing an immunocompromised individual that have children in the family setting.
Famlies without children
Families containing an immunocompromised individual that do not have children in the family setting.
- To define the role of household contact with children or siblings in the transmission of SARS-CoV-2 to immunocompromised patients. [ Time Frame: 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
- To characterize secondary cases of SARS-CoV-2 in immunocompromised participants [ Time Frame: 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 [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
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): NCT04407546
|Contact: Ashley Gray, M.D.||310 825-6708||AshleyGray@mednet.ucla.edu|
|Contact: Mikayla Henderson||310 825-6742||MMHenderson@mednet.ucla.edu|
|United States, California|
|University of California at Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Mikayla Henderson 310-825-6742 MMHenderson@mednet.ucla.edu|
|Principal Investigator: Grace Aldrovandi, MD|
|Principal Investigator:||Grace Aldrovandi, M.D.||University of Califiornia at Los Angeles|