Distribution of age, sex, race, and ethnicity in COVID-19 clinical drug trials in the United States: A review.

BACKGROUND: COVID-19 quickly overwhelmed the world, but disproportionately affects certain communities, particularly minority groups. Despite overrepresentation among COVID-19 cases and death, minority groups were underrepresented in some of the early COVID-19 clinical trials. OBJECTIVE: To assess and compare the demographic characteristics of COVID-19 clinical trial participants to national COVID-19 data. METHODS: PubMed was searched from December 1, 2019 to November 24, 2020, for randomized controlled trials evaluating a pharmacologic treatment for COVID-19 patients from one or more U.S. sites written in the English language following the PRISMA checklist. Descriptive statistics were calculated to characterize patient demographics enrolled in the included clinical trials, as well as for comparison with national COVID-19 data. RESULTS: A total of 4472 records were identified, of which 16 studies were included. The median number of participants was higher in studies of nonhospitalized patients compared to those of hospitalized patients (n = 452 [range 20-1062] vs n = 243 [152-2795]). Ten (63%) studies reported mean or median ages of 50 years or older among all study arms. Males comprised more than half of the study cohort in ten (63%) studies. Race and ethnicity were reported separately in four (25%) studies but were combined when reported in five (31%) studies, while six (38%) reported only race or ethnicity. Proportional representation based on age, sex, race, and ethnicity was evident in some trials, but not in others, when compared to national data. CONCLUSION: Overall, participants often did not reflect the actual population with COVID-19 and demographic characteristics were inconsistently reported.

Clinical Severity on Hospital Admission for COVID-19: An Analysis of Social Determinants of Health From an Early Hot Spot in the Southeastern U.S.

INTRODUCTION: Disparities in COVID-19 infection, illness severity, hospitalization, and death are often attributed to age and comorbidities, which fails to recognize the contribution of social, environmental, and financial factors on health. The purpose of this study was to examine relationships between social determinants of health (SDOH) and COVID-19 severity. METHODS: This multicenter retrospective study included adult patients hospitalized with COVID-19 in Southwest Georgia, U.S. The primary outcome was the severity of illness among patients on hospital admission for COVID-19. To characterize the effect of biological and genetic factors combined with SDOH on COVID-19, we used a multilevel analysis to examine patient-level and ZIP code-level data to determine the risk of COVID-19 illness severity at admission. RESULTS: Of 392 patients included, 65% presented with moderate or severe COVID-19 compared to 35% with critical disease. Compared to moderate or severe COVID-19, increasing levels of Charlson Comorbidity Index (OR 1.15, 95% CI 1.07-1.24), tobacco use (OR 1.85, 95% CI 1.10-3.11), and unemployment or retired versus employed (OR 1.91, 95% CI 1.04-3.50 and OR 2.17, 95% CI 1.17-4.02, respectively) were associated with increased odds of critical COVID-19 in bivariate models. In the multi-level model, ZIP codes with a higher percentage of Black or African American residents (OR 0.94, 95% CI 0.91-0.97) were associated with decreased odds of critical COVID-19. CONCLUSION: Differences in SDOH did not lead to significantly higher odds of presenting with severe COVID-19 when accounting for patient-level and ZIP code-level variables.

COVID-19 vaccination among pregnant people in the United States: a systematic review.

OBJECTIVE: Pregnant people are at increased risk of COVID-19-related morbidity and mortality, and vaccination presents an important strategy for preventing negative outcomes. However, pregnant people were not included in vaccine trials, and there are limited data on COVID-19 vaccines during pregnancy. The objectives of this systematic review were to identify the safety, immunogenicity, effectiveness, and acceptance of COVID-19 vaccination among pregnant people in the United States. DATA SOURCES: Four databases (PubMed, Web of Science, CINAHL, and Google Scholar) were used to identify eligible studies published from January 1, 2020 through February 6, 2022. STUDY ELIGIBILITY CRITERIA: Inclusion criteria were peer-reviewed empirical research conducted in the United States, publications in English, and research addressing 1 of the following topics: safety, immunogenicity, effectiveness, and acceptance of COVID-19 vaccination among pregnant people. METHODS: A narrative synthesis approach was used to synthesize findings. Critical appraisal was done using the JBI (formerly Joanna Briggs Institute) tool. RESULTS: Thirty-two studies were identified. Most studies (n=24) reported the use of Pfizer and Moderna COVID-19 vaccines among pregnant people; only 6 reported the Janssen vaccine. Of the 32 studies, 11 examined COVID-19 vaccine safety, 10 investigated immunogenicity and effectiveness, and 11 assessed vaccine acceptance among pregnant people. Injection-site pain and fatigue were the most common adverse events. One case study reported immune thrombocytopenia. COVID-19 vaccination did not increase the risk of adverse pregnancy or neonatal outcomes compared with unvaccinated pregnant people. After COVID-19 vaccination, pregnant people had a robust immune response, and vaccinations conferred protective immunity to newborns through breast milk and placental transfer. COVID-19 vaccine acceptance was low among pregnant people in the United States. African American race, Hispanic ethnicity, younger age, low education, previous refusal of the influenza vaccine, and lack of provider counseling were associated with low vaccine acceptance. CONCLUSION: Peer-reviewed studies support COVID-19 vaccine safety and protective effects on pregnant people and their newborns. Future studies that use rigorous methodologies and include diverse populations are needed to confirm current findings. In addition, targeted and tailored strategies are needed to improve vaccine acceptance, especially among minorities.

Integrating and Disseminating Pre-Exposure Prophylaxis (PrEP) Screening and Dispensing for Black Men Who Have Sex With Men in Atlanta, Georgia: Protocol for Community Pharmacies.

BACKGROUND: Black men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United States. Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 99% among men who have sex with men, yet profound racial disparities in the uptake of PrEP persist. Low PrEP uptake in BMSM is driven by poor access to PrEP, including inconvenient locations of PrEP-prescribing physicians, distrust of physicians, and stigma, which limit communication about PrEP and its side effects. Previous work indicates that offering HIV prevention services in pharmacies located in low-income, underserved neighborhoods is feasible and can reduce stigma because pharmacies offer a host of less stigmatized health services (eg, vaccinations). We present a protocol for a pharmacy PrEP model that seeks to address challenges and barriers to pharmacy-based PrEP specifically for BMSM. OBJECTIVE: We aim to develop a sustainable pharmacy PrEP delivery model for BMSM that can be implemented to increase PrEP access in low-income, underserved neighborhoods. METHODS: This study design is a pilot intervention to test a pharmacy PrEP delivery model among pharmacy staff and BMSM. We will examine the PrEP delivery model's feasibility, acceptability, and safety and gather early evidence of its impact and cost with respect to PrEP uptake. A mixed-methods approach will be performed, including three study phases: (1) a completed formative phase with qualitative interviews from key stakeholders; (2) a completed transitional pilot phase to assess customer eligibility and willingness to receive PrEP in pharmacies during COVID-19; and (3) a planned pilot intervention phase which will test the delivery model in 2 Atlanta pharmacies in low-income, underserved neighborhoods. RESULTS: Data from the formative phase showed strong support of pharmacy-based PrEP delivery among BMSM, pharmacists, and pharmacy staff. Important factors were identified to facilitate the implementation of PrEP screening and dissemination in pharmacies. During the transitional pilot phase, we identified 81 individuals who would have been eligible for the pilot phase. CONCLUSIONS: Pharmacies have proven to be a feasible source for offering PrEP for White men who have sex with men but have failed to reach the most at-risk, vulnerable population (ie, BMSM). Increasing PrEP access and uptake will reduce HIV incidence and racial inequities in HIV. Translational studies are required to build further evidence and scale pharmacy-based PrEP services specifically for populations that are disconnected from HIV prevention resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35590.