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

Immunosuppression Clinical Trial

Official title:

Role of Children in the Transmission of SARS-CoV-2 in Households of Immunocompromised Persons

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04407546
• Other study ID #: 20-000517
• Secondary ID: NCI-2020-03669
• Status: Terminated
• Start date: May 27, 2020
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression

Locations

Country	Name	City	State
United States	University of California at Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the role of household contact with children or siblings in the transmission of SARS-CoV-2 to immunocompromised patients.	Measure the incidence of transmission of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children	up to one year
Secondary	To characterize secondary cases of SARS-CoV-2 in immunocompromised participants	Measure the rate of serology conversion of SARS-CoV-2 to immunocompromised patients in households with children compared to households without children	up to one year
Secondary	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	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.	up to one year