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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Immunosuppression

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ashley Gray, M.D. 310 825-6708 AshleyGray@mednet.ucla.edu
Contact: Mikayla Henderson 310 825-6742 MMHenderson@mednet.ucla.edu

Locations
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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         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Grace Aldrovandi, M.D. University of Califiornia at Los Angeles
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04407546    
Other Study ID Numbers: 20-000517
NCI-2020-03669 ( Registry Identifier: CTRP )
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No