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NCT05655546 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Participants could report an adverse event at any time during their participation.
Other-event reporting threshold
0%

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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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 / 4950 / 4950 / 495
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 / 5210 / 5210 / 521

Group identifiers: EG000: Intervention Arm · EG001: Control Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      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.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        495
        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. 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.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        495
        serious Num Affected
        0
        serious Num At Risk
        495
        title
        Intervention Arm
      2. deaths Num Affected
        0
        deaths Num At Risk
        521
        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
        EG001
        other Num Affected
        0
        other Num At Risk
        521
        serious Num Affected
        0
        serious Num At Risk
        521
        title
        Control Arm
      frequency Threshold
      0
      time Frame
      Participants could report an adverse event at any time during their participation.

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

      Preserved source evidence · Not medical advice