Community-Based Public Health Vaccination Campaign (VaccinateLA) in Los Angeles' Black and Latino Communities: Protocol for a Participatory Study.

BACKGROUND: The COVID-19 pandemic has significantly affected Los Angeles County and disproportionately impacted Black and Latino populations who experienced disparities in rates of infection, hospitalizations, morbidity, and mortality. The University of Southern California (USC), USC Keck School of Medicine, Southern California Clinical and Translational Science Institute, USC Mann School of Pharmacy and Pharmaceutical Sciences, Annenberg School for Journalism and Communication, and Children's Hospital Los Angeles will launch a collaborative public health campaign called VaccinateLA. OBJECTIVE: VaccinateLA will implement a community-based, community-partnered public health campaign that (1) delivers culturally tailored information about COVID-19 and available vaccines; and (2) addresses misinformation and disinformation, which serves as a barrier to vaccine uptake. The campaign will be targeted to communities in Los Angeles with the highest rates of COVID-19 infection and the lowest vaccination rates. Using these criteria, the campaign will be targeted to neighborhoods located in 34 zip codes in the Eastside and South Los Angeles. The primary aim of VaccinateLA will be to design and deliver an evidence-based multimedia public health campaign tailored for Black and Latino populations. A secondary aim will be to train and deploy community vaccine navigators to deliver COVID-19 education, help individuals overcome barriers to getting vaccinated (eg, transportation and challenges registering), and assist with delivering vaccinations in our targeted communities. METHODS: We will use a community-based, participatory research approach to shape VaccinateLA's public health campaign to address community members' attitudes and concerns in developing campaign content. We will conduct focus groups, establish a community advisory board, and engage local leaders and stakeholders to develop and implement a broad array of educational, multimedia, and field-based activities. RESULTS: As of February 2023, target communities have been identified. The activities will be initiated and evaluated over the course of this year-long initiative, and dissemination will occur following the completion of the project. CONCLUSIONS: Engaging the community is vital to developing culturally tailored public health messages that will resonate with intended audiences. VaccinateLA will serve as a model for how an academic institution can quickly mobilize to address a pressing public health crisis, particularly in underrepresented and underresourced communities. Our work has important implications for future public health campaigns. By leveraging community partnerships and deploying community health workers or promotores into the community, we hope to demonstrate that urban universities can successfully partner with local communities to develop and deliver a range of culturally tailored educational, multimedia, and field-based activities, which in turn may change the course of an urgent public health crisis, such as the COVID-19 pandemic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40161.

REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19.

BACKGROUND: In the phase 1-2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern. METHODS: In the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated. RESULTS: Covid-19-related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P = 0.002). The median time to resolution of symptoms was 4 days shorter with each REGEN-COV dose than with placebo (10 days vs. 14 days; P<0.001 for both comparisons). REGEN-COV was efficacious across various subgroups, including patients who were SARS-CoV-2 serum antibody-positive at baseline. Both REGEN-COV doses reduced viral load faster than placebo; the least-squares mean difference in viral load from baseline through day 7 was -0.71 log10 copies per milliliter (95% confidence interval [CI], -0.90 to -0.53) in the 1200-mg group and -0.86 log10 copies per milliliter (95% CI, -1.00 to -0.72) in the 2400-mg group. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200-mg group (1.1%) and the 2400-mg group (1.3%); infusion-related reactions of grade 2 or higher occurred in less than 0.3% of the patients in all groups. CONCLUSIONS: REGEN-COV reduced the risk of Covid-19-related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04425629.).

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19.

BACKGROUND: Recent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads. METHODS: In this ongoing, double-blind, phase 1-3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.4 g of REGN-COV2, or 8.0 g of REGN-COV2 and were prospectively characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody-positive or serum antibody-negative). Key end points included the time-weighted average change in viral load from baseline (day 1) through day 7 and the percentage of patients with at least one Covid-19-related medically attended visit through day 29. Safety was assessed in all patients. RESULTS: Data from 275 patients are reported. The least-squares mean difference (combined REGN-COV2 dose groups vs. placebo group) in the time-weighted average change in viral load from day 1 through day 7 was -0.56 log10 copies per milliliter (95% confidence interval [CI], -1.02 to -0.11) among patients who were serum antibody-negative at baseline and -0.41 log10 copies per milliliter (95% CI, -0.71 to -0.10) in the overall trial population. In the overall trial population, 6% of the patients in the placebo group and 3% of the patients in the combined REGN-COV2 dose groups reported at least one medically attended visit; among patients who were serum antibody-negative at baseline, the corresponding percentages were 15% and 6% (difference, -9 percentage points; 95% CI, -29 to 11). The percentages of patients with hypersensitivity reactions, infusion-related reactions, and other adverse events were similar in the combined REGN-COV2 dose groups and the placebo group. CONCLUSIONS: In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629.).