NEW YORK – Targeting immunocompromised people who remain vulnerable to COVID-19 as community precautions decline, Scripps Research and Cue Health are testing whether rapid at-home testing paired with telemedicine access could reduce hospitalizations.
Julia Moore Vogel, program director for The Participant Center in the Scripps Research Translational Institute's All of Us Research Program, said Scripps is recruiting 10,000 immunocompromised individuals for the Cue Health-sponsored study called ImmunoCare, which will examine the efficacy of detecting early-stage SARS-CoV-2 infections and treating COVID-19 before the development of serious disease. Half of the participants will receive the firm's Cue Readers and a monthly supply of 10 tests per household, and the other half will continue testing for COVID-19 as they see fit in both testing frequency and technology. The study will last three to eight months, depending on SARS-CoV-2 infection rates.
The study is open to people who are immunocompromised due to conditions and infections such as HIV, graft- or transplant-related disease, immunoglobulin deficiency, immunosuppressive therapy, leukemia, lymphoma, and myeloma.
The 5,000 patients who are enrolled in the intervention arm of the study will also receive on-demand access to the San Diego-based firm's Cue Care virtual consultation service and deliveries of prescription drugs such as the antiviral Paxlovid for those who test positive for COVID-19. The service is similar to the Cue+ membership program the firm launched in 2021 and is currently available as a $20 per month plan that provides discounts on Cue readers and tests, virtual health sessions, and same-day delivery of prescribed antiviral drugs.
Participants from both the treatment and control groups will also complete monthly surveys about SARS-CoV-2 virus exposure, infections, and hospitalizations. Though the study will primarily measure hospitalizations, the researchers also intend to compare infection rates, ICU admissions, deaths, and cost of care across the groups, according to a description from the National Institutes of Health.
Vogel noted that many immunocompromised individuals remain at high risk of contracting COVID-19 and developing health complications and feel left behind in the pandemic response.
"The precautions are lifted, and there's no masking in most places," she said. "And they are still at really high risk and feel that their risk is not taken into account as much as it should be in the overall public health guidance, at this point."
David Tsay, chief medical officer for Cue Health, said in a statement that the ImmunoCare study led by Scripps researchers will provide "pivotal data on how the high accuracy of molecular at-home tests such as Cue’s COVID-19 test can enable earlier detection for high-risk individuals that can lead to better health outcomes.”
Cue Health declined to provide details on its financial commitment to the study.
The firm also said that it is providing the Cue Health Monitoring System instruments and COVID-19 test cartridges free of charge to participants in the study's intervention arm. It sought the partnership with Scripps because of the institute's clinical research leadership, including Scripps' work on the Digital Engagement and Tracking for Early Control and Treatment (DETECT) study that enrolled 40,000 participants in the US and used data from wearable sensors to identify early signs of illness.
The researchers recommend that the participants who receive the Cue Health tests use them when a household member is symptomatic for COVID-19 or when they are potentially exposed to the SARS-CoV-2 virus. They are not mandating any testing routine, however. The researchers hope to learn about real-world testing behavior, and, while testing at set intervals could catch more cases, they instead decided on a study design that is similar to existing testing practices and payor reimbursement practices and, as a result, could help evaluate interventions that are more likely to be implemented at scale if they show a benefit to immunocompromised individuals, Vogel said.
"Part of what we'll be observing in the study is 'Are people using even the tests that we give them for free at the rate that we would expect?'" Vogel said.
The study limits participation to people who have coverage from insurers that have agreed to provide claims data related to COVID-19, including Medicare, Medicaid, Anthem Blue Cross Blue Shield companies, and some other providers. Those agreements allow data collection without relying on participant effort and recall, and Cue Health's app for administering tests also reports data to the researchers, Vogel said.
The ImmunoCare study also includes use of antigen tests to measure symptom reemergence — or "COVID-19 rebound" — following Paxlovid use but does not involve any further examination or comparison of antigen-based tests versus the Cue Health tests, she said.
Cue Health said it wants to participate in more of this type of clinical research. Diagnostics-led healthcare with fast, accurate at-home molecular testing, such as the testing offered by Cue Health, can help people make healthier choices, it said.
"Particularly with the new XBB variants, certain treatment options are no longer effective for vulnerable populations like those who are immunocompromised, so there is a great clinical need to expand the treatment tool set for these patients," the company said. "We’re excited to see how the Cue platform, which brings fast and accurate at-home testing, can enable early detection and subsequent treatment of COVID-19 for the immunocompromised, ultimately reducing adverse outcomes such as hospitalization."
The firm's participation in the ImmunoCare study comes as it faces its own challenges, including layoffs and soft financial results.
During Q3, though, the firm submitted its influenza A/B test to the US Food and Drug Administration for de novo clearance, applied for Emergency Use Authorization for its combination test for COVID-19 and influenzas A and B, and began clinical studies for its respiratory syncytial virus test.
The ImmunoCare study is one of several programs testing the value of increasing at-home COVID-19 testing and treatment services.
The NIH said earlier this month that its pilot Home Test to Treat program would provide up to 8,000 people with at-home COVID-19 antigen tests, telehealth sessions, and home delivery of antivirals. The same day, the telehealth firm Sesame and Lucira Health said they were partnering to deliver Sesame consultations to people who buy Lucira's molecular COVID-19 test as well as treatment options and prescriptions.