NCT05655546 · REGISTRY CONDITION SEARCH

ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2025-08-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Hospitalizations Including COVID Medications

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outcome · POSTED

Cost of Care

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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: 1. Use of smartphone, including camera and bluetooth 2. Upload verification of diagnosis, if needed 3. Completing Surveys 4. Use of Cue Health App 5. Use of MyDataHelps Web or App * Immunocompromised due to disease or therapy, including: 1. Symptomatic HIV 2. Graft versus host disease 3. Immunoglobulin deficiency/Immunodeficiency 4. Immunosuppressive therapy 5. Leukemia 6. Lymphoma (Hodgkin or non-Hodgkin) 7. Metastatic Cancer 8. Multiple Myeloma 9. Solid organ malignancy 10. Transplant, hematopoietic stem cell 11. 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: 1. Anthem BlueCross and BlueShield 2. Anthem BlueCross 3. Empire BlueCross BlueShield 4. Empire BlueCross 5. Wellpoint 6. Carelon 7. Unicare 8. Simply Healthcare Plans 9. National Government Services, Inc. 10. MMM 11. Health Sun 12. HealthLink 13. Amerigroup 14. Medicare 15. Medicaid 16. Or another partner that can provide claims data on participant's behalf Exclusion Criteria: -Unable to meet inclusion criteria
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants 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.
intervention Names
Other: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
label
Intervention Arm
type
OTHER
description
Participants 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.
label
Control Arm
type
NO_INTERVENTION

interventions

arm Group Labels
Intervention Arm
description
Participants will receive at home COVID-19 test for themselves and others in their household.
name
Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

OTHER

Enrollment

count: 2117
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Hospitalizations Including COVID Medications
time Frame
During study participation (on average 12 months)
description
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
measure
Cost of Care
time Frame
During study participation (on average 12 months)

Full study description

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.
detailed Description: This study is a randomized control trial with 10,000 participants. Participation will last for a minimum of 3 months and maximum of 8 months, depending upon COVID-19 case rates. Half of participants will be randomized to the control group and continue their existing testing and healthcare practices. The remaining participants will be randomized into the intervention arm. Participants in the intervention will receive one Cue Cartridge Reader for the duration of the study and up to 10 Cue COVID Molecular tests per month for their own use and to share with others in their household. In the case that a Cue Flu+COVID Molecular Test is available through FDA EUA or other authorization, participants may be provided this multiplex test in lieu of the Cue COVID Molecular Test. All intervention participants will be asked to test themselves if they are exposed or when symptoms arise and share tests with members of their household who are exposed to COVID or symptoms arise. The primary outcome will be the number of hospitalizations. This study will also compare infection rates, ICU admissions, deaths, and cost of care between the control and intervention group. The hypothesis is that access to high sensitivity portable molecular testing and subsequent telemedicine and prescription delivery can significantly decrease hospitalization and thereby the cost of care. Interested individuals will access the study via the MyDataHelps platform by web or app to complete the eligibility and informed consent process. Within the MyDataHelps experience, participants will complete study activities such as surveys and sharing of claims data. Participants who are randomized to the intervention group will have the option to use Cue Care should they test positive for COVID-19. Cue Care contracts licensed Healthcare providers to deliver telemedicine and treatment for COVID-19. In the case that the COVID Flu+COVID test is available, the intervention group will also have the option to use Cue Care should they test positive for Influenza. To learn more and take the eligibility survey, visit https://ImmunoCARE.scripps.edu/

Source references

references

citation
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
40503088
type
DERIVED