ImmunosuppressionNCT04407546
Role of Children in Transmission of COVID-19 to Immunocompromised Patients
An observational study of Immunosuppression, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 13 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Immunocompromised patients with positive SARS-CoV-2 test prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Los Angeles, California, 90095
About this study
Official title: Role of Children in the Transmission of SARS-CoV-2 in Households of Immunocompromised Persons
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.
Read the 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.
- Conditions
- Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to one year
Secondary outcomes (2)
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
Measured: 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
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.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start27 May 2020
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Why it stopped: enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Aldrovandi, M.D., Principal investigator, University of Califiornia at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407546
- Sponsor's protocol ID
- 20-000517
- Other IDs
- NCI-2020-03669
- Status last verified
- Mar 2023
- First submitted
- 27 May 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Children in the Transmission of SARS-CoV-2 in Households of Immunocompromised Persons
- ClinicalTrials.gov ID
- NCT04407546
- Acronym / sponsor ID
- 20-000517
- Conditions
- Immunosuppression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enrollment
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Immunocompromised patients with positive SARS-CoV-2 test prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To characterize secondary cases of SARS-CoV-2 in immunocompromised participants
Time frame: 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
Time frame: up to one year
Results and safety
The study was stopped early (reason given: enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Aldrovandi, M.D. principal investigator
University of Califiornia at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.