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NCT05655546 · OUTCOME

Number of Participants With Hospitalizations Including COVID Medications

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
During study participation (on average 12 months)

What was measured

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.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Intervention Arm310
Control Arm285

Reported measurements

Source class 1

COVID medication

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Intervention Arm59Not reportedNot reportedNot reportedNot reported
Control Arm58Not reportedNot reportedNot reportedNot reported

COVID hospitalization

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Intervention Arm15Not reportedNot reportedNot reportedNot reported
Control Arm22Not reportedNot reportedNot reportedNot reported

COVID ICU stay

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Intervention Arm1Not reportedNot reportedNot reportedNot reported
Control Arm13Not reportedNot reportedNot reportedNot reported

No COVID infection reported

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Intervention Arm235Not reportedNot reportedNot reportedNot reported
Control Arm192Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        58
      title
      COVID medication
    2. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        22
      title
      COVID hospitalization
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        13
      title
      COVID ICU stay
    4. measurements
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        192
      title
      No COVID infection reported
denoms
  1. counts
    1. group Id
      OG000
      value
      310
    2. group Id
      OG001
      value
      285
    units
    Participants
description
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.
groups
  1. 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
    OG000
    title
    Intervention Arm
  2. 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
    OG001
    title
    Control Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
During study participation (on average 12 months)
title
Number of Participants With Hospitalizations Including COVID Medications
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice