Trial Outcomes & Findings for ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals (NCT NCT05655546)
NCT ID: NCT05655546
Last Updated: 2025-08-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2117 participants
Primary outcome timeframe
During study participation (on average 12 months)
Results posted on
2025-08-08
Participant Flow
Participants were recruited remotely from across the United States.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
495
|
521
|
|
Overall Study
COMPLETED
|
493
|
517
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
Ages were reported for all who responded to the baseline survey
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=310 Participants
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.
|
Control Arm
n=285 Participants
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.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=292 Participants • Ages were reported for all who responded to the baseline survey
|
0 Participants
n=250 Participants • Ages were reported for all who responded to the baseline survey
|
0 Participants
n=542 Participants • Ages were reported for all who responded to the baseline survey
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=292 Participants • Ages were reported for all who responded to the baseline survey
|
72 Participants
n=250 Participants • Ages were reported for all who responded to the baseline survey
|
160 Participants
n=542 Participants • Ages were reported for all who responded to the baseline survey
|
|
Age, Categorical
>=65 years
|
204 Participants
n=292 Participants • Ages were reported for all who responded to the baseline survey
|
178 Participants
n=250 Participants • Ages were reported for all who responded to the baseline survey
|
382 Participants
n=542 Participants • Ages were reported for all who responded to the baseline survey
|
|
Sex/Gender, Customized
Nonbinary
|
8 Participants
n=310 Participants
|
4 Participants
n=285 Participants
|
12 Participants
n=595 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=310 Participants
|
4 Participants
n=285 Participants
|
4 Participants
n=595 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
0 Participants
n=310 Participants
|
0 Participants
n=285 Participants
|
0 Participants
n=595 Participants
|
|
Sex/Gender, Customized
Woman
|
198 Participants
n=310 Participants
|
150 Participants
n=285 Participants
|
348 Participants
n=595 Participants
|
|
Sex/Gender, Customized
Man
|
90 Participants
n=310 Participants
|
94 Participants
n=285 Participants
|
184 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=310 Participants
|
0 Participants
n=285 Participants
|
1 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
White only
|
262 Participants
n=310 Participants
|
218 Participants
n=285 Participants
|
480 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Hispanic only
|
5 Participants
n=310 Participants
|
1 Participants
n=285 Participants
|
6 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
3 Participants
n=310 Participants
|
3 Participants
n=285 Participants
|
6 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=310 Participants
|
1 Participants
n=285 Participants
|
2 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Multiple races/ethnicities
|
12 Participants
n=310 Participants
|
12 Participants
n=285 Participants
|
24 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
3 Participants
n=310 Participants
|
1 Participants
n=285 Participants
|
4 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=310 Participants
|
8 Participants
n=285 Participants
|
16 Participants
n=595 Participants
|
|
Primary eligibility category
Immunocompromised
|
176 Participants
n=310 Participants • 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.
|
160 Participants
n=285 Participants • 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.
|
336 Participants
n=595 Participants • 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.
|
|
Primary eligibility category
Age 65+
|
134 Participants
n=310 Participants • 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.
|
125 Participants
n=285 Participants • 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.
|
259 Participants
n=595 Participants • 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.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Arm
n=310 Participants
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.
|
Control Arm
n=285 Participants
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.
|
|---|---|---|
|
Number of Participants With Hospitalizations Including COVID Medications
COVID ICU stay
|
1 Participants
|
13 Participants
|
|
Number of Participants With Hospitalizations Including COVID Medications
COVID medication
|
59 Participants
|
58 Participants
|
|
Number of Participants With Hospitalizations Including COVID Medications
COVID hospitalization
|
15 Participants
|
22 Participants
|
|
Number of Participants With Hospitalizations Including COVID Medications
No COVID infection reported
|
235 Participants
|
192 Participants
|
PRIMARY outcome
Timeframe: During study participation (on average 12 months)Population: Participants with claims and/or survey data were included.
Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.
Outcome measures
| Measure |
Intervention Arm
n=310 Participants
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.
|
Control Arm
n=285 Participants
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.
|
|---|---|---|
|
Cost of Care
|
2,022 dollars
Interval 0.0 to
|
5,740 dollars
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place