NCT05655546 · BASELINE

Baseline characteristics

ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals · Source last updated 2025-08-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants

groups

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.
id
BG000
title
Intervention 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.
id
BG001
title
Control Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
88
group Id
BG001
value
72
group Id
BG002
value
160
title
Between 18 and 65 years
measurements
group Id
BG000
value
204
group Id
BG001
value
178
group Id
BG002
value
382
title
>=65 years
denoms
counts
group Id
BG000
value
292
group Id
BG001
value
250
group Id
BG002
value
542
units
Participants
description
Participant ages were inferred from their date of birth
param Type
COUNT_OF_PARTICIPANTS
population Description
Ages were reported for all who responded to the baseline survey
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
4
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Nonbinary
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
4
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Transgender
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Prefer not to answer
categories
measurements
group Id
BG000
value
198
group Id
BG001
value
150
group Id
BG002
value
348
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Woman
categories
measurements
group Id
BG000
value
90
group Id
BG001
value
94
group Id
BG002
value
184
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Man
param Type
COUNT_OF_PARTICIPANTS
title
Sex/Gender, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Middle Eastern
categories
measurements
group Id
BG000
value
262
group Id
BG001
value
218
group Id
BG002
value
480
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
White only
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Hispanic only
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Black / African American
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Other
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
12
group Id
BG002
value
24
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Multiple races/ethnicities
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Prefer not to answer
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Asian
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
176
group Id
BG001
value
160
group Id
BG002
value
336
title
Immunocompromised
measurements
group Id
BG000
value
134
group Id
BG001
value
125
group Id
BG002
value
259
title
Age 65+
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
description
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.
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
title
Primary eligibility category
unit Of Measure
Participants

population Description

These participants completed the baseline survey where demographics were reported.

Complete source fields

denoms

counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants

groups

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.
id
BG000
title
Intervention 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.
id
BG001
title
Control Arm
description
Total of all reporting groups
id
BG002
title
Total

measures

calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
88
group Id
BG001
value
72
group Id
BG002
value
160
title
Between 18 and 65 years
measurements
group Id
BG000
value
204
group Id
BG001
value
178
group Id
BG002
value
382
title
>=65 years
denoms
counts
group Id
BG000
value
292
group Id
BG001
value
250
group Id
BG002
value
542
units
Participants
description
Participant ages were inferred from their date of birth
param Type
COUNT_OF_PARTICIPANTS
population Description
Ages were reported for all who responded to the baseline survey
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
4
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Nonbinary
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
4
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Transgender
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Prefer not to answer
categories
measurements
group Id
BG000
value
198
group Id
BG001
value
150
group Id
BG002
value
348
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Woman
categories
measurements
group Id
BG000
value
90
group Id
BG001
value
94
group Id
BG002
value
184
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Man
param Type
COUNT_OF_PARTICIPANTS
title
Sex/Gender, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Middle Eastern
categories
measurements
group Id
BG000
value
262
group Id
BG001
value
218
group Id
BG002
value
480
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
White only
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Hispanic only
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Black / African American
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Other
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
12
group Id
BG002
value
24
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Multiple races/ethnicities
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Prefer not to answer
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
title
Asian
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
176
group Id
BG001
value
160
group Id
BG002
value
336
title
Immunocompromised
measurements
group Id
BG000
value
134
group Id
BG001
value
125
group Id
BG002
value
259
title
Age 65+
denoms
counts
group Id
BG000
value
310
group Id
BG001
value
285
group Id
BG002
value
595
units
Participants
description
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.
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
title
Primary eligibility category
unit Of Measure
Participants

population Description

These participants completed the baseline survey where demographics were reported.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice