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NCT05655546 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Control Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        495
      2. group Id
        FG001
        num Subjects
        521
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        493
      2. group Id
        FG001
        num Subjects
        517
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
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.
recruitment Details
Participants were recruited remotely from across the United States.
Complete source fields
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
    FG000
    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
    FG001
    title
    Control Arm
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        495
      2. group Id
        FG001
        num Subjects
        521
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        493
      2. group Id
        FG001
        num Subjects
        517
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
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.
recruitment Details
Participants were recruited remotely from across the United States.

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

Preserved source evidence · Not medical advice