ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Translational Science Institute
Study ID
NCT05655546
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 — OTHER
    Participants will receive at home COVID-19 test for themselves and others in their household.

Study Details

The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.

Key Dates

Start date
Dec 22, 2022
Status verified
Jul 2025
Primary completion
Jun 20, 2024
Completion
Jun 20, 2024

Study Design

Enrollment
2,117 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: 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.
  • No Intervention: 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.

Primary Outcome Measure

Number of Participants With Hospitalizations Including COVID Medications [ Time Frame: During study participation (on average 12 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps ResearchLa JollaCalifornia92037-

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