In partnership with Cue Health, the study will deploy at-home COVID-19 tests, on-demand telemedicine and delivery of antiviral medication in an effort to lessen severe disease outcomes.
LA JOLLA, CA—While COVID-19 vaccines have been proven to protect most people from adverse outcomes, for the more than seven million immunocompromised people in the United States, the risk of developing severe disease remains high.
To help address this issue, scientists at the Scripps Research Translational Institute have partnered with healthcare technology company Cue Health to launch ImmunoCARE, a remote trial aimed at reducing hospitalizations and other severe outcomes in immunocompromised people infected with SARS-CoV-2, the virus that causes COVID-19.
By providing study participants with a combination of fast and accurate molecular at-home tests to diagnose infection, on-demand telemedicine consultations, and same-day delivery of antivirals (if medically indicated) to treat COVID-19, the team seeks to determine if early detection of infection and treatment can reduce hospitalizations and adverse outcomes in this vulnerable population.
“It’s taking too long to get help to the people who need it the most,” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute and co-principal investigator of the study. “The continued evolution of the virus and its ability to escape our immune response has rendered monoclonal antibodies ineffective, making it all the more important for us to continue to innovate and develop tools to protect the immunocompromised and elderly.”
Immunocompromised individuals have a reduced ability to fight off infections and other illnesses due to medical conditions or because they are taking immunosuppressive medications. These include people with autoimmune diseases, such as rheumatoid arthritis and lupus. Some conditions, like HIV and AIDS, destroy immune cells, leaving the body with fewer defenses to fend off infections. Additionally, some medications, such as immunosuppressive therapies taken by transplant recipients to ensure their bodies don’t reject the organs they’ve received, can reduce immune function.
“In many ways, the immunocompromised community is more at risk now than they were earlier in the pandemic. We’re no longer seeing non-pharmaceutical interventions to prevent transmission, such as masking and isolating when exposed to COVID-19, being employed by a large proportion of the public, leaving immunocompromised people to fend for themselves,” says Julia Moore Vogel, PhD, co-principal investigator of ImmunoCARE and a program director at the Scripps Research Translational Institute. “This study is our attempt to help this vulnerable group of people avoid severe outcomes.”
The ImmunoCARE study will provide half of the participants (those who are randomized for intervention) with up to ten Cue COVID-19 Tests for Home and Over The Counter (OTC) Use every month for their own use and to share with members of their household. These nucleic acid amplification tests detect the genomic RNA of SARS-CoV-2 and are much more sensitive than rapid antigen tests commonly used to test for COVID-19. The study seeks to determine whether early detection can reduce transmission within the household and enable early treatment when immunocompromised individuals test positive.
“This study, led by world-class researchers at Scripps Research, will provide pivotal data on whether access to highly accurate molecular at-home tests such as Cue’s COVID-19 test will facilitate earlier detection among high-risk individuals and lead to better health outcomes,” says David Tsay, MD, PhD, chief medical officer at Cue Health.
Participants will also have the option to utilize Cue’s telemedicine and prescription delivery services to obtain antiviral medication, if eligible, to treat infection. Scientists will compare infection rates, emergency department visits, ICU admissions, deaths and cost of care between the control and intervention groups by reviewing insurance claims data at the conclusion of the study.
The study is fully remote, leveraging the MyDataHelps mobile app-based research platform developed by CareEvolution, a health technology company that enables secure and reliable sharing of clinical health information. The ImmunoCARE study plans to enroll 10,000 immunocompromised participants nationwide.
For more details about the ImmunoCare study, visit immunocare.scripps.edu.
Disclaimer: Cue’s COVID-19 tests have not been FDA cleared or approved; but have been authorized by FDA and under an Emergency Use Authorization (EUA). These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Medication requires prescription and is subject to availability, independent judgment of the provider, and patient eligibility.