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On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.
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| Name | Class |
|---|---|
| Cue Health | UNKNOWN |
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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.
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/
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 | Other | Participants will receive at home COVID-19 test for themselves and others in their household. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During study participation (on average 12 months) |
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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:
Immunocompromised due to disease or therapy, including:
Age 1. 65 years and older
Option if under 65 to share claims data as a member of one of the following insurance providers:
Exclusion Criteria:
-Unable to meet inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Research | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40503088 | Derived | 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. |
| Label | URL |
|---|---|
| Study website | View source |
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After completing consent, participants verify their eligibility by connecting their health plan or EHR data, or manually sharing information to verify their eligibility. After confirmation of eligibility, participants are randomized into control or intervention arms. Many participants completed enrollment but did not verify their eligibility and therefore are not included in the randomized participants count.
Participants were recruited remotely from across the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2024 |
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| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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These participants completed the baseline survey where demographics were reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participant ages were inferred from their date of birth | Ages were reported for all who responded to the baseline survey | Count of Participants | Participants | No |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Primary eligibility category | We analyzed the data based on whether participants primarily met eligibility criteria by being immunocompromised or at least age 65; if a participant was both, they were assigned to the immunocompromised group. | This information was collected based on the eligibility verification process and is only presented for participants that shared outcome data. These subgroups are reported on in the analysis. | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During study participation (on average 12 months) |
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| Primary | Cost of Care | Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms. | Participants with claims and/or survey data were included. | Posted | Mean | 95% Confidence Interval | dollars | During study participation (on average 12 months) |
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Participants could report an adverse event at any time during their participation.
Participants were able to report adverse events to the study team by email at any time. EHR and claims data were also analyzed for mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 495 | 0 | 495 | 0 | 495 |
| EG001 | 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. | 0 | 521 | 0 | 521 | 0 | 521 |
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The study ended early because the intervention device's FDA approval was revoked. As a result the study was underpowered and the intervention is no longer available.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Moore Vogel | Scripps Research | 8587842275 | immunocare@scripps.edu |
| Jun 24, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2023 | Jun 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D015658 | HIV Infections |
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D009101 | Multiple Myeloma |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Transgender |
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| Prefer not to answer |
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| Woman |
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| Man |
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| White only |
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| Hispanic only |
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| Black / African American |
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| Other |
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| Multiple races/ethnicities |
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| Prefer not to answer |
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| Asian |
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| COVID ICU stay |
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| No COVID infection reported |
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