Advancing Health Equity for American Indian and Alaska Native People Through Inclusion in Clinical Trials: Anti-SARS-CoV-2 Monoclonal Antibody Treatment and COVID-19 Outcomes Among Ambulatory Cherokee Nation Health Services Patients.

Abstract

Background: Racial/ethnic minority groups are underrepresented in clinical trials with American Indian and Alaska Native (AI/AN) people having the lowest representation. This article aims to contribute to the literature to address that gap by sharing the results of the use of anti-SARS-CoV-2 monoclonal antibodies among AI/AN people at risk for severe COVID-19.

Methods: This retrospective cohort study assessed data from ambulatory AI/AN patients enrolled in Cherokee Nation Health Services in Northeastern Oklahoma, who had a positive test for SARS-CoV-2, high risk for progression, and were offered anti-SARS-CoV-2 monoclonal antibody treatment active against the circulating SARS-CoV-2 strain from December 1, 2020, to April 16, 2021. The outcomes of interest were all-cause and COVID-19-related emergency department visits, hospitalizations, intensive care admissions, and deaths within 28 days of being offered treatment.

Results: Among 1,447 participants, 813 (56.2%) were treated and 634 (43.8%) were not. When adjusted for potential confounders, there was a significant difference in the odds of treated versus untreated patients experiencing a COVID-19-related emergency department visit (OR, 0.42; 95% CI, 0.27-0.63) and hospitalization (OR, 0.10; 95% CI, 0.03-0.31).

Discussion: Anti-SARS-CoV-2 monoclonal antibody treatment was associated with lower odds of COVID-19-related emergency department visits and hospitalization among high-risk AI/AN patients.

Health equity implications: To advance health equity, it is critical to have representation of AI/AN in clinical trials and other research. This project is an example of how community partnerships with AI/AN health systems can strengthen the evidence for new and emerging treatments, address past harm, and advance equity.