Author: Lauren Serpico –
The risks associated with COVID-19 infection are higher for immunocompromised individuals and those who are 65 and older, than the general public. ImmunoCARE is an innovative research project aimed at identifying how we can potentially reduce those risks. Our team is studying whether repeated at-home tests, on-demand telemedicine, and quick delivery of medication for those who test positive for COVID-19 can reduce symptom severity in immunocompromised people and those over 65.
ImmunoCARE is a joint research project from Scripps Research and Cue Health, a leading healthcare technology company that develops portable diagnostic tests for at-home use.
The Motivation Behind ImmunoCARE
Clinical research often has a population-level approach, which is important to ensure we are developing new treatments at scale. This approach often has the unintended consequence of sub-populations waiting for answers more specific to their underlying conditions. Given the unique health risks of immunocompromised individuals and those over 65, it’s important we consider them in the context of COVID-19 infection.
In a recent move by the FDA, Evusheld, a therapy for immunocompromised people that has waned in efficacy as the coronavirus has mutated, has had its emergency-use authorization revoked on January 26th. In a recent Time article, Dr. Eric Topol notes a critical gap now exists in how immunocompromised people are treated for COVID-19.
With the data gathered in this study on COVID-19 outcomes among immunocompromised people and those over 65, Dr. Topol and the ImmunoCARE team hope to help prevent hospitalization, and ultimately shape improved models of prevention and treatment through rigorous evidence-based research.
Partnering With an Appropriate Cohort
Even with vaccination, immunocompromised individuals as well as people over the age of 65 face higher risk of adverse outcomes, hospitalization, and death (ref 1, ref 2, ref 3, ref 4). Individuals considered moderately to severely immunocompromised are eligible to participate in this study, such as those with symptomatic HIV, leukemia, or solid organ transplant. Any individual 65 years of age or older is also eligible to participate, due to the risk of severe outcomes and hospitalization within this age group. Eligibility will be automatically verified via insurance claims data.
Participants will be asked to complete study activities such as surveys on the MyDataHelps app. For those randomly assigned to the intervention group, they will also receive 10 Cue Health COVID-19 molecular tests per month for themselves and others in their household. Our aim is to reduce household transmission with these tests for others to use if they are symptomatic or have been exposed to COVID-19. If a participant tests positive, they will have access to telemedicine, and if clinically indicated, the appropriate medicine will be delivered to the participant’s address.
Transforming How and Where Clinical Research is Done
ImmunoCARE participants are asked to complete monthly surveys about COVID-19 exposure, rapid test results, and hospitalization via compatible smartphone, and be willing and able to share their health insurance claims data. Claims data are used so that the researchers are able to understand the care participants received from a number of providers, without the participant having to update this information manually. Participant data will never be used for advertising, will never be sold, and is securely stored.
The Scripps Research Digital Trials Center is advancing science with an approach that invites anyone, anywhere to raise their hand and contribute to and benefit from medical research. With the remote nature of digital clinical trials, projects can be more inclusive, reaching people who have been historically underrepresented in biomedical research, and can help transform research “subjects” into true partners.
To learn more about ImmunoCARE, visit immunocare.scripps.edu