ImmunodeficiencyNCT05655546
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
A study testing Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 in people with Immunodeficiency and Immunosuppression, run by Scripps Translational Science Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Immunodeficiency, Immunosuppression, HIV Infections
- What is being tested?
- Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,117 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 41Show fewer
- Use of smartphone, including camera and bluetooth
- Upload verification of diagnosis, if needed
- Completing Surveys
- Use of Cue Health App
- Use of MyDataHelps Web or App
- Immunocompromised due to disease or therapy, including:
- Symptomatic HIV
- Graft versus host disease
- Immunoglobulin deficiency/Immunodeficiency
- Immunosuppressive therapy
- Leukemia
- Lymphoma (Hodgkin or non-Hodgkin)
- Metastatic Cancer
- Multiple Myeloma
- Solid organ malignancy
- Transplant, hematopoietic stem cell
- 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:
- Anthem BlueCross and BlueShield
- Anthem BlueCross
- Empire BlueCross BlueShield
- Empire BlueCross
- Wellpoint
- Carelon
- Unicare
- Simply Healthcare Plans
- National Government Services, Inc.
- MMM
- Health Sun
- HealthLink
- Amerigroup
- Medicare
- Medicaid
- Or another partner that can provide claims data on participant's behalf
Who cannot join
- -Unable to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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/
- Conditions
- Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia, Lymphoma
- Being tested
- Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
- Keywords
- COVID-19, Immunocompromised, Advanced Age, Medicare, Medicaid
- Medical subject headings
- Immunologic Deficiency Syndromes, HIV Infections, Graft vs Host Disease, Leukemia, Lymphoma, Neoplasms, Multiple Myeloma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Cue Health COVID-19 Remote testing and treatment for COVID-19Other
Participants will receive at home COVID-19 test for themselves and others in their household.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | 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. Receives: Other: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 |
| Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hospitalizations Including COVID Medications
In claims data COVID hospital admissions were defined as: claim type is "HOSP" or "Institutional" or location display contains "inpatient" with COVID diagnosis or COVID procedure or COVID medication in the same medical episode. In survey data, participants were asked to self-report COVID hospitalizations.
Measured: During study participation (on average 12 months)
Cost of Care
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
Measured: During study participation (on average 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start22 Dec 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Why it stopped: On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunodeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cue Health
- Responsible party
- Principal investigator, Julia Moore Vogel, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655546
- Sponsor's protocol ID
- IRB-22-8082
- Status last verified
- Jul 2025
- First submitted
- 9 Dec 2022
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogel 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.
PubMed 40503088
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
- ClinicalTrials.gov ID
- NCT05655546
- Acronym / sponsor ID
- IRB-22-8082
- Conditions
- Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia, Lymphoma
- Keywords
- COVID-19, Immunocompromised, Advanced Age, Medicare, Medicaid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
- Enrolment
- 2,117 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Cue Health
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Other: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19Participants 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. |
| Control Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- 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)
Key exclusion criteria (1 listed)
- -Unable to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to Cue Health COVID-19 Remote testing and treatment for COVID-19Participants will receive at home COVID-19 test for themselves and others in their household. | Other | Intervention Arm |
Primary outcome
Number of Participants With Hospitalizations Including COVID Medications
Time frame: During study participation (on average 12 months)
In claims data COVID hospital admissions were defined as: claim type is "HOSP" or "Institutional" or location display contains "inpatient" with COVID diagnosis or COVID procedure or COVID medication in the same medical episode. In survey data, participants were asked to self-report COVID hospitalizations.
Cost of Care
Time frame: During study participation (on average 12 months)
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40503088Vogel 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 in people with Immunodeficiency and Immunosuppression, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hospitalizations Including COVID Medications (time frame: During study participation (on average 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.