In an industry-funded phase 3 trial, bamlanivimab plus etesevimab decreased COVID-19 hospitalization and death in ambulatory patients with mild to moderate COVID-19 who were at high risk for disease progression. Researchers randomly assigned 1,035 outpatients in the U.S. with mild or moderate COVID-19 (mean age, 53.8 years) to receive an infusion of bamlanivimab-etesevimab or placebo within three days of laboratory-confirmed diagnosis. Eleven of 518 patients (2.1%) in the treatment group had a COVID-19-related hospitalization or death from any cause at day 29 versus 36 of 517 patients (7.0%) in the placebo group (relative risk difference, 70%; P<0.001). Patients in the treatment group also had a greater reduction from baseline in log viral load than those who received placebo. Ten patients died in the placebo group, nine of COVID-19-related causes, while no patients died in the treatment group. The results of the study, which was funded by Eli Lilly, were published July 14 by the New England Journal of Medicine. The authors concluded that their results “show the clinical benefit of early testing for SARS-CoV-2 infection coupled with prompt intervention with neutralizing antibody therapy in high-risk ambulatory patients,” as well as provide context for the FDA's recent emergency use authorization for this drug combination in this group.
The FDA announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 vaccine on July 13, noting an increased risk for Guillain-Barré syndrome (GBS). An analysis of data from the Vaccine Adverse Event Reporting System found 100 preliminary reports of GBS after administration of about 12.5 million doses. Ninety-five cases required hospitalization, and one patient died. The FDA said that the data suggest a relationship between the Janssen vaccine and GBS but that causality cannot be determined and stressed that the benefits of vaccination “clearly outweigh” the risks.
Finally, two studies looked at communication with patients on COVID-19 prevention, including in minority groups. A randomized clinical trial published in JAMA Network Open on July 14 looked at whether messages delivered by physicians improved knowledge and preventive behaviors in 18,223 adults who self-identified as Black (n=9,168) or White (n=9,055) and had less than a college education. The researchers also evaluated whether targeting messages to the Black community affected impact. The trial was performed from Aug. 7 to Sept. 6, 2020, and video messages were delivered by a Black or White physician. Those in control groups saw three videos on generic health topics, while those in treatment groups saw videos related to COVID-19, with one video in one treatment group addressing racial disparities. The control and intervention groups were also randomly assigned to watch one of two statements from the American Medical Association on either structural racism or drug price transparency.
Participants in the intervention groups had smaller gaps in COVID-19 knowledge (incidence rate ratio [IRR], 0.89; 95% CI, 0.87 to 0.91) and more demand for COVID-19 information (IRR, 1.05; 95% CI, 1.01 to 1.11) and were more willing to pay for a face mask (difference, $0.50; 95% CI, $0.15 to $0.85). No difference in effects was seen by race or in different intervention groups. The authors concluded that a physician messaging campaign effectively increased COVID-19 knowledge, information seeking, and self-reported protective behaviors in this diverse group of patients and that both Black and White physicians engendered high levels of trust. They called for more studies to determine whether such interventions affect clinical outcomes. An accompanying editorial noted that the study was done before COVID-19 vaccines were widely available and that the findings could have implications for increasing vaccine uptake.
Another study in JAMA Network Open, meanwhile, found that efforts to decrease vaccine hesitancy among Black and Latinx patients must acknowledge their perspectives. In 13 group and individual interviews in New Jersey conducted between Nov. 19, 2020, and Feb. 5, 2021, researchers asked 111 Black and Latinx participants about their experiences during the pandemic and their thoughts on mitigation, COVID-19 testing, and vaccines. The results were published July 15. High rates of information seeking, mitigation behaviors, and testing were reported, and vaccine skepticism was also high. Participants were concerned that COVID-19 vaccines had been developed too quickly and were worried about short- and long-term adverse events. They also wanted more information about vaccine effectiveness, specifically in their own communities. Black patients expressed distrust of the government and of health care systems and concerns about racism and medical experimentation. “Our findings should serve as a cautionary note to decision makers who would simply provide reassurance or dismiss wariness about the COVID-19 vaccine among communities of color as owing to lack of knowledge,” the authors wrote. “Instead, we illustrate the need for clear, transparent information sharing and community-engaged strategies that can facilitate informed choices.”