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COVID-19 Home Testing + Telemedicine for Immunocompromised Patients
N/A
Recruiting
Research Sponsored by Scripps Translational Science Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
Study Summary
This trial will test if a combo of at-home tests, telemedicine, and prescriptions can reduce severe outcomes & costs for immunocompromised COVID-19 patients.
Who is the study for?
This trial is for U.S. residents aged 18+, who can read English, use a compatible smartphone, and are vaccinated against COVID-19. It's specifically for those immunocompromised due to conditions like HIV, cancer, or treatments such as transplants. Participants must be willing to engage with study tools and share health data.Check my eligibility
What is being tested?
The ImmunoCARE trial tests if at-home COVID testing combined with telemedicine support and rapid delivery of medications like Paxlovid can reduce hospitalization in immunocompromised individuals or those over 65 compared to standard care.See study design
What are the potential side effects?
Potential side effects may include reactions related to the remote testing process or adverse effects from COVID-19 treatments delivered during the trial (e.g., Paxlovid), which will vary based on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cost of care
Number of hospitalizations
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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.
Group II: Control ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
Scripps Translational Science InstituteLead Sponsor
51 Previous Clinical Trials
569,561 Total Patients Enrolled
Cue HealthUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received the full COVID-19 vaccination, such as both doses of Moderna or Pfizer, or one dose of J&J.You have a weakened immune system due to certain diseases or treatments, including HIV, organ transplant, cancer, or certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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