COVID-19 Trials: Who Participates and Who Benefits?

Narayanasamy, Shanti; Mourad, Ahmad; Turner, Nicholas A; Le, Thuy; Rolfe, Robert J; Okeke, Nwora Lance; O'Brien, Sean M; Baker, Arthur W; Wrenn, Rebekah; Rosa, Rossana; Rockhold, Frank W; Naggie, Susanna; Stout, Jason E

COVID-19 Trials: Who Participates and Who Benefits?

dc.contributor.author	Narayanasamy, Shanti
dc.contributor.author	Mourad, Ahmad
dc.contributor.author	Turner, Nicholas A
dc.contributor.author	Le, Thuy
dc.contributor.author	Rolfe, Robert J
dc.contributor.author	Okeke, Nwora Lance
dc.contributor.author	O'Brien, Sean M
dc.contributor.author	Baker, Arthur W
dc.contributor.author	Wrenn, Rebekah
dc.contributor.author	Rosa, Rossana
dc.contributor.author	Rockhold, Frank W
dc.contributor.author	Naggie, Susanna
dc.contributor.author	Stout, Jason E
dc.date.accessioned	2022-09-01T13:22:29Z
dc.date.available	2022-09-01T13:22:29Z
dc.date.issued	2022-04
dc.date.updated	2022-09-01T13:22:29Z
dc.description.abstract	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.
dc.identifier	SMJ_220174
dc.identifier.issn	0038-4348
dc.identifier.issn	1541-8243
dc.identifier.uri	https://hdl.handle.net/10161/25626
dc.language	eng
dc.publisher	Southern Medical Association
dc.relation.ispartof	Southern medical journal
dc.relation.isversionof	10.14423/smj.0000000000001374
dc.subject	Humans
dc.subject	Minority Groups
dc.subject	Aged
dc.subject	United States
dc.subject	COVID-19
dc.subject	Ethnicity
dc.subject	Hispanic or Latino
dc.subject	Blacks
dc.title	COVID-19 Trials: Who Participates and Who Benefits?
dc.type	Journal article
duke.contributor.orcid	Mourad, Ahmad\|0000-0002-3149-597X
duke.contributor.orcid	Turner, Nicholas A\|0000-0003-0650-4894
duke.contributor.orcid	Le, Thuy\|0000-0002-3393-6580
duke.contributor.orcid	Baker, Arthur W\|0000-0002-0914-0291
duke.contributor.orcid	Rockhold, Frank W\|0000-0003-3732-4765
duke.contributor.orcid	Naggie, Susanna\|0000-0001-7721-6975
duke.contributor.orcid	Stout, Jason E\|0000-0002-6698-8176
pubs.begin-page	256
pubs.end-page	261
pubs.issue	4
pubs.organisational-group	Duke
pubs.organisational-group	School of Medicine
pubs.organisational-group	Staff
pubs.organisational-group	Basic Science Departments
pubs.organisational-group	Clinical Science Departments
pubs.organisational-group	Institutes and Centers
pubs.organisational-group	Biostatistics & Bioinformatics
pubs.organisational-group	Molecular Genetics and Microbiology
pubs.organisational-group	Medicine
pubs.organisational-group	Medicine, Infectious Diseases
pubs.organisational-group	Duke Clinical Research Institute
pubs.organisational-group	Institutes and Provost's Academic Units
pubs.organisational-group	University Institutes and Centers
pubs.organisational-group	Duke Global Health Institute
pubs.organisational-group	Population Health Sciences
pubs.publication-status	Published
pubs.volume	115