Clinical trial NCT05655546: ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Official title: ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immunodeficiency
Immunosuppression
HIV Infections
Graft Versus Host Disease
Leukemia
Lymphoma
Cancer
Multiple Myeloma
Transplant
Age-Related Immunodeficiency
Keywords: COVID-19
Immunocompromised
Advanced Age
Medicare
Medicaid
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Cue Health
First posted: 2022-12-19
Enrollment: 2117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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/

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

Primary outcomes:
measure: Number of hospitalizations
timeFrame: 8 months
measure: Cost of care
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Research
state: California
Study officials:
References: