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

NCT ID: NCT05655546

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2024-06-20

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/

Conditions

Immunodeficiency; Immunosuppression; HIV Infections; Graft Versus Host Disease; Leukemia; Lymphoma; Cancer; Multiple Myeloma; Transplant; Age-Related Immunodeficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: OTHER

Access to Cue Health COVID-19 Remote testing and treatment for COVID-19

Intervention Type: OTHER

Participants will receive at home COVID-19 test for themselves and others in their household.

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Access to Cue Health COVID-19 Remote testing and treatment for COVID-19

Participants will receive at home COVID-19 test for themselves and others in their household.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cue Health

UNKNOWN

Sponsor Role: collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Julia Moore Vogel

Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Scripps Research

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40503088 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://immunocare.scripps.edu/

Study website

Other Identifiers

IRB-22-8082

Identifier Type: -

Identifier Source: org_study_id