This study monitors adult and children family members to understand the role that household contact plays in the transmission of SARS-CoV-2 in immunocompromised households. The SARS-CoV-2 is the respiratory virus that causes COVID-19. Children are known to be notorious viral vectors eager to share their secretions, and they play an important role in spreading of respiratory viral infections. By collecting biospecimen samples and monitoring children and their family members, researchers may learn how COVID-19 spreads in households of people who have compromised immune systems, which may help to better care for COVID-19 patients in the future. Additionally, researchers are evaluating the immunological responses in immunocompromised participants following SARS-CoV-2 directed vaccination.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04407546.
PRIMARY OBJECTIVES:
I. To define the role of household contact with children or siblings in the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to immunocompromised patients.
Ia. Estimate the secondary infection rate for the immunocompromised patient from household contacts (primary outcome).
Ib. Determine if the secondary infection rate differs between immunocompetent and immunocompromised patients in the same household.
II. 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.
III. To characterize secondary cases of SARS-CoV-2 in immunocompromised participants including:
IIIa. The number of asymptomatic, mild and severe infections.
IIIb. The range of clinical presentations.
IIIc. Risk factors for infection and clinical progression.
IIId. The duration and pattern of viral positivity by nucleic acid testing (polymerase chain reaction [PCR]) and culture in respiratory secretions and feces.
IIIe. Evaluate clinical predictors of virus shedding.
IV. To characterize the immunologic response following confirmed coronavirus disease-2019 (COVID-19) infection in households.
OUTLINE:
Participants undergo collection of nasal swab, saliva, and blood samples at baseline and 6 month. Participants then undergo at home collection of saliva and nasal swab samples and complete online questionnaires over 15-30 minutes every 2 weeks for up to 6 months. Participants found to be positive for COVID-19 are contacted immediately and referred for medical evaluation and confirmatory testing. Participants with positive research-use only SARS-CoV-2 test undergo collection of saliva and nasal swabs samples twice a week for 4 weeks and undergo collection blood sample weekly for 4 weeks after which time participants return to the every 2 week collections. Immunocompromised participants may undergo collection of additional nasal and blood samples at 4-8 weeks after completion of their vaccine.
After completion of enrollment, participants are followed up at 1 year.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorGrace Aldrovandi
