Study Stopped
On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
1 other identifier
interventional
2,117
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
December 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedResults Posted
Study results publicly available
August 8, 2025
CompletedAugust 8, 2025
July 1, 2025
1.5 years
December 9, 2022
May 9, 2025
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Hospitalizations Including COVID Medications
In claims data COVID hospital admissions were defined as: claim type is "HOSP" or "Institutional" or location display contains "inpatient" with COVID diagnosis or COVID procedure or COVID medication in the same medical episode. In survey data, participants were asked to self-report COVID hospitalizations.
During study participation (on average 12 months)
Cost of Care
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
During study participation (on average 12 months)
Study Arms (2)
Intervention Arm
OTHERParticipants in this group will complete the baseline study activities, as described above. Additionally, participants will be instructed to create a Cue Health account and download the Cue Health App. Using the app and the 10 Cue Health COVID-19 molecular tests that are provided (or Cue Health Flu+COVID molecular tests if available and FDA authorized), the participant will perform tests after exposure or if symptoms arise. Participants can also use the test for close contacts who are exposed to COVID-19 and/or have symptoms. If COVID-19 infection occurs, participants will have access to telemedicine to discuss further with a healthcare professional. When clinically indicated, medication for the treatment of COVID-19 (and/or Influenza in case of Cue Health Flu+COVID test availability) will be prescribed and delivered to the participants' delivery address. Participants can also seek care through other healthcare providers or not seek care, at their discretion.
Control Arm
NO INTERVENTIONParticipants in the control group will complete the baseline study activities, as described above. If symptoms arise or COVID-19 infection occurs, participants will test and seek care as they normally would.
Interventions
Participants will receive at home COVID-19 test for themselves and others in their household.
Eligibility Criteria
You may qualify if:
- Living in the United States
- 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
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Translational Science Institutelead
- Cue Healthcollaborator
Study Sites (1)
Scripps Research
La Jolla, California, 92037, United States
Related Publications (1)
Vogel JM, Hung TY, Coughlin E, Delgado F, Kheterpal V, Quer G, Topol E. A Randomized Trial of At-Home COVID-19 Tests, Telemedicine, and Rapid Prescription Delivery for Immunocompromised Individuals. Mayo Clin Proc Innov Qual Outcomes. 2025 May 22;9(3):100627. doi: 10.1016/j.mayocpiqo.2025.100627. eCollection 2025 Jun.
PMID: 40503088DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study ended early because the intervention device's FDA approval was revoked. As a result the study was underpowered and the intervention is no longer available.
Results Point of Contact
- Title
- Julia Moore Vogel
- Organization
- Scripps Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director
Study Record Dates
First Submitted
December 9, 2022
First Posted
December 19, 2022
Study Start
December 22, 2022
Primary Completion
June 20, 2024
Study Completion
June 20, 2024
Last Updated
August 8, 2025
Results First Posted
August 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share