COVID-19 Trials: Who Participates and Who Benefits?

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has disproportionately afflicted vulnerable populations. Older adults, particularly residents of nursing facilities, represent a small percentage of the population but account for 40% of mortality from COVID-19 in the United States. Racial and ethnic minority individuals, particularly Black, Hispanic, and Indigenous Americans have experienced higher rates of infection and death than the White population. Although there has been an unprecedented explosion of clinical trials to examine potential therapies, participation by members of these vulnerable communities is crucial to obtaining data generalizable to those communities. METHODS: We undertook an open-label, factorial randomized clinical trial examining hydroxychloroquine and/or azithromycin for hospitalized patients. RESULTS: Of 53 screened patients, 11 (21%) were enrolled. Ten percent (3/31) of Black patients were enrolled, 33% (7/21) of White patients, and 50% (6/12) of Hispanic patients. Forty-seven percent (25/53) of patients declined participation despite eligibility; 58%(18/31) of Black patients declined participation. Forty percent (21/53) of screened patients were from a nursing facility and 10% (2/21) were enrolled. Enrolled patients had fewer comorbidities than nonenrolled patients: median modified Charlson comorbidity score 2.0 (interquartile range 0-2.5), versus 4.0 (interquartile range 2-6) for nonenrolled patients (P = 0.006). The limitations of the study were the low participation rate and the multiple treatment trials concurrently recruiting at our institution. CONCLUSIONS: The high rate of nonparticipation in our trial of nursing facility residents and Black people emphasizes the concern that clinical trials for therapeutics may not target key populations with high mortality rates.

Impact of COVID-19 pandemic on pharmacist-led allergy assessments and penicillin skin testing.

Allergy assessments and penicillin skin testing are associated with reductions in high-Clostridioides difficile infection (CDI)-risk antibiotic use and lower hospital-acquired CDI rates; however, these activities require substantial personnel and resource allocation. Recently, many antimicrobial stewardship programs' (ASPs) focus shifted towards supporting the COVID-19 pandemic response. We evaluated the impact of the COVID-19 pandemic on a pharmacist-led allergy assessment and penicillin skin testing program. Patients undergoing allergy assessment and/or penicillin skin testing (PST) from 1 January 2017 through 30 April 2021 were included for review. Monthly PST and allergy assessment rates were calculated and defined as the number of PSTs or allergy assessments per 1000 unique patient encounters for each month, respectively. The study used interrupted time series regression to assess potential level and slope changes in allergy assessments and PSTs during the pandemic. 200 058 total inpatient encounters by 188 867 unique patients occurred during the study period. ASP performed 918 allergy assessments and 204 PSTs. The local onset of the SARS-CoV-2 pandemic during March 2020 was associated with significant level reductions in allergy assessments and PSTs. Additional responsibilities added to the ASP team during the COVID-19 pandemic limited the ability to perform core antimicrobial stewardship activities with proven patient care benefits.