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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05655546
• Other study ID #: IRB-22-8082
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: June 20, 2024

Study information

• Verified date: May 2024
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2117
• Est. completion date: June 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Immunodeficiency
• Cancer
• Graft Versus Host Disease
• Graft vs Host Disease
• HIV Infections
• Immunodeficiency
• Immunologic Deficiency Syndromes
• Immunosuppression
• Leukemia
• Lymphoma
• Multiple Myeloma
• Transplant

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Research	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Cue Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalizations	Investigators will compare the number of hospitalizations between the control and intervention arms.	8 months
Primary	Cost of care	Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.	8 months

External Links

•   Study website