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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05655546
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Scripps Translational Science Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia, Lymphoma, Cancer, Multiple Myeloma, Transplant, Age-Related Immunodeficiency
Study Website: View Trial Website
Additional Details

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/

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scripps Research, La Jolla, California

Status

Recruiting

Address

Scripps Research

La Jolla, California, 92037

Site Contact

Erin Coughlin

ImmunoCARE@scripps.edu

18007274777