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

NCT04407546 | Terminated

• 2 other identifiers: 20-000517NCI-2020-03669
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To characterize secondary cases of SARS-CoV-2 in immunocompromised participants

  up to one year

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potentially eligible patients will be identified through examination of the electronic health record to identify patients receiving chemotherapy who are potentially eligible and could be approached for participation. Invitation to the study will occur through the MyChart portal or paper mailing letter, and those who are interested in participation will contact the research coordinator by phone or e-mail to undergo telephone screening for study eligibility. In addition, the research team member will explain the study objectives and procedures, and assess interest in participation. Pediatric recruitment of solid organ and hematopoietic stem cell transplantation patients will be done in collaboration with those respective primary pediatric subspecialist. The pediatric subspecialist teams will identify the patients who meet the inclusion criteria and will send the recruitment letter directly to the parents or patients if \>18 years old via MyChart or paper mailed letter.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects to provide biological specimens including nasal swabs, saliva and blood. Thereafter, participants will complete at-home nasal swab collections on a weekly basis for 6 months. If our research-use only SARS-CoV-2 test is positive, participants will be referred immediately to UCLA 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.

Study Officials

• Grace Aldrovandi, M.D.

  University of Califiornia at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: May 27, 2020
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)