← Back to Search

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Scripps Translational Science InstituteLead Sponsor

51 Previous Clinical Trials

569,561 Total Patients Enrolled

Cue HealthUNKNOWN

Media Library

Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 Clinical Trial Eligibility Overview. Trial Name: NCT05655546 — N/A

Human Immunodeficiency Virus Infection Research Study Groups: Intervention Arm, Control Arm

Human Immunodeficiency Virus Infection Clinical Trial 2023: Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 Highlights & Side Effects. Trial Name: NCT05655546 — N/A

Access to Cue Health COVID-19 Remote testing and treatment for COVID-19 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655546 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process for this medical research project currently open?

"As per the records on clinicaltrials.gov, this trial is seeking participants at present. It was made public on December 22nd 2022 and its information has been updated as recently as March 9th 2023."

Answered by AI

Does this research encompass participants aged 45 and above?

"In order to enroll in this clinical trial, potential participants must be 18 years of age or older - the maximum allowable age for study participation is 120."

Answered by AI

How extensive is the participant pool for this experiment?

"Indeed, the information available on clinicaltrials.gov confirms that this scientific venture is currently recruiting participants. First posted in December 2022 and most recently updated in March 2023, it needs to enrol 10000 people from one medical facility."

Answered by AI

What are the prerequisites for participating in this investigation?

"This clinical trial seeks to enrol 10,000 individuals aged between 18 and 120 who have been diagnosed with cancer. Additionally, participants must be immunocompromised due to disease or therapy such as HIV, Graft versus host disease, Immunoglobulin deficiency/Immunodeficiency, Immunosuppressive therapy, Leukemia, Lymphoma (Hodgkin or non-Hodgkin), Metastatic Cancer, Multiple myeloma and Solid organ malignancy; Transplantation of hematopoietic stem cell or solid organs; use of smartphones with Bluetooth connectivity along with a camera and compatible"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Julia Moore Vogel 2022. "ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05655546.

All > Graft Vs Host Disease > Leukemia