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

A legfontosabb adatok

Ki végzi
Scripps Translational Science Institute
Hol
La Jolla (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Leállítva
Résztvevők
2117 fő vett részt
Kezdés
2022. dec. 22.
Befejezés
2024. jún. 20.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Access to Cue Health COVID-19 Remote testing and treatment for COVID-19
A regiszteradat frissítve
2025. augusztus 8.
Miért állt le
On May 13, 2024, the FDA released a communication that Cue Health tests should no longer be used.

Ki vehet részt

Életkor
18 év – 120 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 25 feltétel megnézéseKevesebb

Ki vehet részt

  • Living in the United States
  • 18 years or older
  • Can read and understand English
  • Use of smartphone with bluetooth, a camera and a compatible operating system (Android OS 9.0 or higher, Apple iOS 13.0 or higher)
  • Vaccinated against COVID-19 (completed at least the initial course, e.g. at least 2 doses of -Moderna or Pfizer, one dose of J\&J)
  • Willing and able to participate in study interventions including:; Use of smartphone, including camera and bluetooth; Upload verification of diagnosis, if needed; Completing Surveys; Use of Cue Health App; Use of MyDataHelps Web or App
  • Immunocompromised due to disease or therapy, including:; Symptomatic HIV; Graft versus host disease; Immunoglobulin deficiency/Immunodeficiency; Immunosuppressive therapy; Leukemia; Lymphoma (Hodgkin or non-Hodgkin); Metastatic Cancer; Multiple Myeloma; Solid organ malignancy; Transplant, hematopoietic stem cell; Transplant, solid organ
  • Age 1. 65 years and older; Option if under 65 to share claims data as a member of one of the following insurance providers:
  • Anthem BlueCross and BlueShield
  • Anthem BlueCross
  • Empire BlueCross BlueShield
  • Empire BlueCross
  • Wellpoint
  • Carelon
  • Unicare
  • Simply Healthcare Plans
  • National Government Services, Inc
  • MMM
  • Health Sun
  • HealthLink
  • Amerigroup
  • Medicare
  • Medicaid
  • Or another partner that can provide claims data on participant's behalf

Ki nem vehet részt

  • -Unable to meet inclusion criteria

Helyszínek itt: Egyesült Államok

  • Scripps ResearchLa Jolla, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

  • Intervention ArmEgyéb csoport

    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.

    Kezelés: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19

  • Control ArmNincs vizsgálati kezelés, összehasonlításként

    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.

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
A regiszteradat frissítve
2025. augusztus 8.