ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Reason given: On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
Key facts
- Where
- La Jolla, United StatesSee the site
Where in United States
- Scripps ResearchLa Jolla, United StatesNo longer taking part
Trial details
- Who runs it
- Scripps Translational Science Institute
- Trial code
- NCT05655546
- Record updated
- 8 August 2025
- Original description
The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.Read full original descriptionShow less
The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.
Inclusion: Living in the United States; 18 years or older; Can read and understand English; Use of smartphone with bluetooth, a camera and a compatible operating system (Android OS 9.0 or higher, Apple iOS 13.0 or higher); Vaccinated against COVID-19 (completed at least the initial course, e.g. at least 2 doses of -Moderna or Pfizer, one dose of J\&J); Willing and able to participate in study interventions including:; Use of smartphone, including camera and bluetooth; Upload verification of diagnosis, if needed; Completing Surveys; Use of Cue Health App; Use of MyDataHelps Web or App; Immunocompromised due to disease or therapy, including:; Symptomatic HIV; Graft versus host disease; Immunoglobulin deficiency/Immunodeficiency; Immunosuppressive therapy; Leukemia; Lymphoma (Hodgkin or non-Hodgkin); Metastatic Cancer; Multiple Myeloma; Solid organ malignancy; Transplant, hematopoietic stem cell; Transplant, solid organ; Age 1. 65 years and older; Option if under 65 to share claims data as a member of one of the following insurance providers:; Anthem BlueCross and BlueShield; Anthem BlueCross; Empire BlueCross BlueShield; Empire BlueCross; Wellpoint; Carelon; Unicare; Simply Healthcare Plans; National Government Services, Inc; MMM; Health Sun; HealthLink; Amerigroup; Medicare; Medicaid; Or another partner that can provide claims data on participant's behalf.
Exclusion: -Unable to meet inclusion criteria.