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

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05655546
Collaborator
Cue Health (Other)
10,000
Enrollment
1
Location
2
Arms
12.3
Anticipated Duration (Months)
811.7
Patients Per Site Per Month

Study Details

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. They will also analyze whether these efforts lower the cost of care compared to standard of care.

Condition or Disease Intervention/Treatment Phase
  • Other: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
 N/A

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/

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10000 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Anticipated Study Start Date :
Dec 22, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of hospitalizations [8 months]

    Investigators will compare the number of hospitalizations between the control and intervention arms.

  2. Cost of care [8 months]

    Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Able 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Research La Jolla California United States 92037

Sponsors and Collaborators

  • Scripps Translational Science Institute
  • Cue Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Julia Moore Vogel, Program Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT05655546
Other Study ID Numbers:
  • IRB-22-8082
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julia Moore Vogel, Program Director, Scripps Translational Science Institute
COVID-19
Immunocompromised
Additional relevant MeSH terms:
Multiple Myeloma
Graft vs Host Disease

Study Results

No Results Posted as of Dec 27, 2022