Clinical trial · Interventional
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
NCT05655546CI-TRIAL-00093369terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Age-Related Immunodeficiency | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| HIV Infections | — | UNRESOLVED | — |
| Immunodeficiency | — | UNRESOLVED | — |
| Immunosuppression | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Intervention Arm
- description
- 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.
- interventionNames
- Other: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVogel 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. PMID 40503088