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Recruiting
NCT05655546
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Conditions: Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia, Lymphoma, Cancer, Multiple Myeloma, Transplant
Sex: All
Ages: 18 Years – 110 Years
Phase: NA
Enrollment: 10000
Sponsor: Scripps Translational Science Institute
Location: United States
Summary
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.
They will also analyze whether these efforts lower the cost of care compared to standard of care.
Eligibility Criteria
Inclusion Criteria:Living in the United States18 years or olderCan read and understand EnglishUse 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 bluetoothUpload verification of diagnosis, if neededCompleting SurveysUse of Cue Health AppUse of MyDataHelps Web or AppImmunocompromised due to disease or therapy, including:Symptomatic HIVGraft versus host diseaseImmunoglobulin deficiency/ImmunodeficiencyImmunosuppressive therapyLeukemiaLymphoma (Hodgkin or non-Hodgkin)Metastatic CancerMultiple MyelomaSolid organ malignancyTransplant, hematopoietic stem cellTransplant, solid organAble to share claims data as a member of one of the following insurance providers:Anthem BlueCross and BlueShieldAnthem BlueCrossEmpire BlueCross BlueShieldEmpire BlueCrossWellpointCarelonUnicareSimply Healthcare PlansNational Government Services, Inc.MMMHealth SunHealthLinkAmerigroupMedicareMedicaidOr another partner that can provide claims data on participant's behalfExclusion Criteria:Unable to meet inclusion criteria
Source: ClinicalTrials.gov (NCT05655546). StuddyBuddy aggregates publicly available trial information.