PCORI Biweekly COVID-19 Scan: Treating Mild to Moderate COVID-19, Mental and Behavioral Health in Adolescents/Young Adults (January 6-19, 2022)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
In the past 2 weeks, 5 studies have been published about pregnancy and COVID-19 that might help increase vaccination rates among pregnant people. COVID-19 vaccination rates in this group are currently lower than among the general population.
In the United States, retrospective evidence shows that vaccination during pregnancy demonstrated no increased risk of preterm birth or small-for-gestational-age birth. Furthering the case for vaccination during pregnancy, Scottish and US studies suggest that unvaccinated women who became infected with SARS CoV-2 were more likely to experience stillbirth, complications, or maternal death compared with vaccinated women.
In addition, a smaller study showed that infection during pregnancy elicits an immune response in the fetus that can still be measured after birth even though the infant does not have COVID-19. Another small study suggests that breastfeeding is safe. Although SARS-CoV-2 viral RNA was detected in the breastmilk of mothers with recent infection, no sign of infectivity or coronavirus replication was detected.
Meanwhile, as the pandemic continues into its third year, the health care industry continues to explore interventions that might address both physical and mental health needs (see Topics to Watch).
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Bebtelovimab (LY-CoV1404) to Treat Mild to Moderate COVID-19
At a Glance
- Bebtelovimab is a monoclonal antibody therapy being investigated to treat patients with mild to moderate COVID-19. Monoclonal antibodies work by blocking the virus from attaching to and infecting human cells.
- Mutations in some SARS-CoV-2 virus variants have resulted in total or partial resistance to most of the available monoclonal antibody treatments, prompting a need for new treatments capable of neutralizing the currently circulating variants.
- Laboratory studies have found that bebtelovimab’s binding and neutralizing activity is unaffected by most mutations in the receptor-binding domain of the COVID-19 spike protein, allowing it to still be effective against variants such as Omicron.
- The company announced it is pursuing FDA Emergency Use Authorization (EUA) for bebtelovimab in the first quarter of 2022.
Bebtelovimab (Eli Lilly and Company, Indianapolis, IN) is a SARS-CoV-2 glycoprotein receptor-binding domain (RBD)-specific monoclonal antibody under investigation to treat patients with mild to moderate COVID-19.
Monoclonal antibodies are laboratory-manufactured proteins designed to mimic the body’s natural immune response, which recognizes and neutralizes foreign pathogens. The SARS-CoV-2 virus is able to enter human host cells through the interaction of viral spike (S) proteins expressed on the surface the virus, with the broadly expressed angiotensin-converting enzyme 2 (ACE-2) receptor on human cell surfaces. Treatments targeting the S protein intend to impair the virus’s ability to enter cells to replicate and then infect other cells.
Because natually occurring mutations in the S protein can affect the ability of antibodies to recognize it, there is an ongoing need for effective treatments as novel SARS-CoV-2 variants arise. Many antibodies that have been granted EUA by the FDA have been shown to be less effective at treating some COVID-19 variants. Bebtelovimab is designed to bind to a portion of the S protein that rarely mutates, potentially increasing the effectiveness of it against current and future variants.
A recent preclinical, nonpeer reviewed study suggests bebtelovimab is effective against the highly mutated Omicron variant and Delta variant, and might be several times more potent compared with other functionally similar antibodies.
Eli Lilly has announced it is pursuing FDA EUA for bebtelovimab, which just completed a phase 2 trial, in the first quarter of 2022. We were unable to find information regarding the potential cost of a treatment course of bebtelovimab.
The Omicron variant’s increased transmissibility, infectivity, and resistance to available treatments all highlight a need for new and effective treatments. Treatment with bebtelovimab might improve patient health outcomes for patients with mild to moderate COVID-19.
Early feedback from internal ECRI stakeholders suggested that the choice of bebtelovimab’s alternative binding region is promising because it was based on information from an up-to-date database instead of predictive or prospective approaches. It might also preserve the treatment’s effectiveness against future coronavirus variants. If the FDA grants bebtelovimab EUA, already widespread antibody clinics might allow for more patients to benefit from bebtelovimab rapidly, considering the infrastructure is already in place. Health disparities might increase, however, if patients are not able to access treatment due to their location or shortages caused by high demand for bebtelovimab.
- Categories: Treatments
- Areas of potential impact: Patient health outcomes, population health outcomes, health disparities, health care costs, treatment models
Online Single-session Interventions to Treat Mental and Behavioral Health in Adolescents and Young Adults During the COVID-19 Pandemic
At a Glance
- Online single-session mental health interventions might be an accessible, low-cost means to provide timely mental health care to adolescents and young adults.
- Several online single-session mental health interventions are under investigation in the United States and internationally to help close the gap in mental health services.
- Data from an unphased, randomized trial of 2 online, single-session interventions targeting behavioral and cognitive depressive symptoms found that both active interventions increased postintervention agency (ie, the perceived ability to control one's own actions and life circumstances) and reduced depressive symptoms, hopelessness, and restrictive eating at 3 months compared with the supportive control intervention.
- Another study by the University of Pennsylvania found that a single-session intervention improved secondary control and reduced the perceived negative impact of the COVID-19
Online single-session mental health interventions might be an accessible, low-cost means to address the ongoing mental health effects of the COVID-19 pandemic on adolescents and young adults.
Mental health care provider shortages and long appointment wait times predate the COVID-19 pandemic, but adolescent mental health issues due to school closures, reduced activities, social isolation, financial hardship, and stress have been exacerbated by it. Telehealth and other online interventions have been used throughout the pandemic to support mental health care. Several online single-session interventions (SSIs) are under investigation to help close the gap in access to mental health services for adolescents and young adults.
The Lab for Scalable Mental Health at Stony Brook University, in collaboration with the University of Denver, completed an unphased, randomized trial of 2 online, 30-minute, self-administered, SSIs. These interventions targeted behavioral and cognitive depressive symptoms in adolescents aged 13 to 16 (n = 2452) in the context of COVID-19. Results published in December 2021 found that both active interventions increased postintervention agency (ie, the perceived ability to control one's own actions and life circumstances) and reduced depressive symptoms, hopelessness, and restrictive eating at 3 months compared with the supportive control intervention.
The University of Pennsylvania investigated an SSI that utilized the Common Elements Toolbox (COMET), adapted for the COVID-19 pandemic, to support mental health among graduate students. The intervention, focused on behavioral activation and cognitive restructuring, improved secondary control and reduced the perceived negative impact of the COVID-19 pandemic on quality of life from baseline.
Other SSIs are under investigation within the United States by Harvard University, Yale University, and University of Nevada, Reno, and internationally in Kenya, India, and the United Kingdom. Digital mental health interventions are generally considered low-cost, but there is a lack of data on cost-effectiveness.
Effective and timely interventions are needed to combat the pervasive increase in mental health symptoms among adolescents and young adults during the COVID-19 pandemic.
Early feedback from ECRI internal stakeholders suggested that SSIs might increase access to mental health support and alleviate mild anxiety and depressive symptoms quickly and conveniently. Self-administered SSIs might encourage adolescents and young adults to seek treatment, reduce the stigma of mental illness, and improve mental health care coordination. SSIs are unlikely to effectively treat patients with chronic anxiety or depressive disorders, but they might serve as an early intervention.
Upfront costs to develop and implement SSIs might be outweighed by a decreased need for long-term mental health care utilization. SSIs might also help mitigate the worsening mental health care provider shortages. However, SSIs might increase disparities in access to care, especially for people experiencing financial hardship or homelessness, or who do not have access to digital devices and internet service.
- Categories: Treatment
- Areas of potential impact: Patient outcomes, population health outcomes, patient management, care setting, health care disparities, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: January 31, 2022
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