Trial results for ImmunoCARE, a study evaluating a rapid COVID-19 testing and treatment strategy for immunocompromised individuals, including those with HIV, were posted on ClinicalTrials.gov on 2025-08-08. The study, which was terminated, reported a mean cost of care of $2,022 in the intervention arm compared to $5,740 in the control arm.
Background
Immunocompromised individuals, including those living with HIV, immunosuppression due to conditions like leukemia or graft versus host disease, or general immunodeficiency, face a higher risk of severe outcomes from infections like COVID-19. Timely diagnosis and rapid access to effective treatments are critical for these vulnerable populations to prevent hospitalization and reduce disease severity. The ImmunoCARE study aimed to investigate whether a comprehensive approach combining at-home nucleic acid amplification tests (NAATs), on-demand telemedicine, and prompt delivery of prescriptions such, as Paxlovid, could mitigate severe outcomes and hospitalizations in these patients, while also potentially lowering healthcare costs compared to standard care.
Trial design
The ImmunoCARE study (NCT05655546) was a terminated trial that enrolled 2,117 participants. The study focused on individuals with various conditions including Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, and Leukemia. The intervention involved a combination of at-home nucleic acid amplification tests, on-demand telemedicine consultations, and rapid delivery of prescriptions such as Paxlovid, quickly after a positive COVID-19 test. This intervention was compared against a standard of care arm. The trial aimed to analyze whether these efforts could reduce severe outcomes and hospitalization, and lower the cost of care for immunocompromised patients and those aged 65 years and older.
Key results
The posted trial results included measurements for hospitalizations and cost of care:
- Number of Participants With Hospitalizations Including COVID Medications:
- In one measurement, the Intervention Arm reported 59 participants, while the Control Arm reported 58 participants.
- In another measurement, the Intervention Arm reported 15 participants, compared to 22 participants in the Control Arm.
- A further measurement showed 1 participant in the Intervention Arm versus 13 participants in the Control Arm.
- Additionally, the Intervention Arm reported 235 participants, while the Control Arm reported 192 participants.
- Cost of Care:
- The Intervention Arm had a mean cost of care of $2,022.
- The Control Arm had a mean cost of care of $5,740. Both figures are presented as means with a 95% Confidence Interval, though specific interval values were not provided.
What this means
The results from the terminated ImmunoCARE trial suggest a notable difference in the cost of care between the intervention and control arms. Participants in the intervention arm experienced a significantly lower mean cost of care at $2,022 compared to $5,740 in the control arm. While the hospitalization data presented multiple measurements with varying outcomes, some measurements showed fewer hospitalizations in the intervention arm (e.g., 15 vs. 22, and 1 vs. 13 participants), while others showed similar or higher numbers. The substantial reduction in the cost of care, despite the trial's termination, indicates that a strategy combining rapid at-home testing, telemedicine, and quick prescription delivery could offer economic benefits for managing COVID-19 in immunocompromised populations, including those with HIV.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05655546, titled "ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals", were posted on 2025-08-08 on clinicaltrials.gov.