PCORI Biweekly COVID-19 Scan: Treating Mild to Moderate COVID-19, Addressing Health Care Staffing Shortages (February 3-16, 2022)

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.

Description

Ensovibep is an antiviral drug being investigated by Novartis (Basel, Switzerland) and Molecular Partners (Zurich-Schlieren, Switzerland) to treat nonhospitalized adults with mild to moderate COVID-19.  

SARS-CoV-2 is able to enter host cells when the receptor-binding domain (RBD) of its spike protein binds to angiotensin-converting enzyme 2 (ACE-2) receptors on the surface of host cells. Ensovibep is designed to bind to SARS-CoV-2’s RBD to prevent it from interacting with host cell ACE-2 receptors, thus preventing the virus from entering and reproducing inside the cells. Ensovibep is a trispecific DARPin, which is a genetically engineered, antibody-like protein designed with 3 unique binding domains that each target 3 different portions of the SARS-CoV-2 RBD, which is thought to increase the drug’s potency and might help it retain effectiveness against future variants of concern. Laboratory data suggest ensovibep is effective against all current SARS-CoV-2 variants of concern, including Omicron. In clinical trials, ensovibep is given as a single intravenous infusion at an unspecified dose within 7 days of symptom onset.

Ensovibep is being studied in an ongoing dose-finding phase 2/3 trial enrolling 2100 nonhospitalized adults with mild to moderate COVID-19. Preliminary phase 2 data on 407 participants reported in January 2022 showed that treatment with ensovibep, compared with placebo, was associated with a reduction in viral load over 8 days and a 78% overall reduced risk of events including COVID-19-related hospitalizations, emergency department visits, and deaths.

Molecular Partners announced on February 10, 2022, that Novartis requested EUA from the FDA for ensovibep to treat COVID-19. Ensovibep was previously granted FDA fast track designation to treat COVID-19 in both hospitalized and ambulatory settings.

We were unable to find information regarding the potential cost of ensovibep.

Commentary

The rise of SARS-CoV-2 variants less susceptible to existing COVID-19 treatments and vaccines signals a need for new and more effective treatment options. Treatment with ensovibep might improve health outcomes for patients with mild to moderate COVID-19 by limiting SARS-CoV-2 replication if the drug retains efficacy as new variants arise.

Early feedback from internal ECRI stakeholders suggested that ensovibep might be effective at reducing COVID-19 disease severity and risk of death and might further help as a treatment option given shortages of existing oral antivirals and monoclonal antibody treatments. Patients at high risk of disease progression need more effective treatments. DARPins investigated in clinical trials for other indications have demonstrated favorable safety profiles, improving the likelihood that the treatment might be authorized in the current year.

Disruption to infrastructure is likely to be limited because patients can receive the drug at existing infusion sites. However, health disparities might increase if the treatment is not accessible in certain areas. It might be challenging to deliver the treatment to patients early enough in the disease course to be most effective. Vaccinated patients with mild disease might be less likely to seek treatment. Patients might also prefer an oral treatment, if available.

• Categories: Treatments
• Areas of potential impact: Costs, health disparities, patient health outcomes, population health outcomes

Description

Description: The Army National Guard, a component of the US military, can be mobilized on federal and state levels to respond to domestic emergencies. As of January 2022, more than 15,600 National Guard members were supporting state and local officials in COVID-19 pandemic efforts in 49 US states and territories. Of those, more than 6,000 members were providing direct aid to hospitals, health care centers, and other medical facilities.

The recent spike in COVID-19 cases due to the Omicron variant worsened existing shortages of health care workers nationwide. Approximately 1 in 4 of the 5,000 US hospitals reporting on their staff status to the US Department of Health and Human Services reported a “critical staffing shortage,” according to data released in early January 2022. This rate is the highest reported since critical hospital staff shortages reported in November 2020.

In response, National Guard members have been deployed to train and work in health care settings. About 70 National Guard members have trained to work as nursing assistants in Wisconsin; more than 180 members in Pennsylvania are assisting in long-term care facilities, helping with medical tasks such as checking vital signs and with nonmedical tasks such as delivering meals and cleaning; and more than 30 soldiers and airmen in New York have trained to work as emergency medical technicians and serve at nursing homes across the state. Other states, including Hawaii, West Virginia, and Vermont, have also received staffing support at vaccination clinics and local hospitals.

In January 2022, it was announced that federal COVID-19 relief funds will now cover National Guard members working in hospitals in addition to other COVID-19 relief efforts previously covered.

Commentary

Mobilizing the National Guard to work in health care settings might increase the capacity for health care staff to meet the medical needs of patients amid the recent surge of COVID-19 cases. This might decrease health care wait times and increase access to care for people with COVID-19 or other health conditions. Federal funds for deploying the National Guard in hospitals might also help reduce costs to hospitals.

Early feedback from ECRI internal stakeholders suggested that deploying the National Guard might help alleviate burnout of health care workers in the short term. However, deployment of the Guard is not a permanent solution. Stakeholders thought the unpredictable nature of COVID-19 might deter health systems from investing in long-term solutions, including in improving mitigation strategies for future emergencies, such as staff retention (eg, better compensation, benefits, and work flexibility), which might cause health systems to continue to rely on the National Guard members for longer.

Stakeholders also thought that the accelerated education and training provided by the National Guard might increase the chances that some people with no previous health care experience might join the health care field.

• Categories: Systems and management
• Areas of potential impact: Patient outcomes, population health outcomes, health care disparities, health care costs, treatment provider

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.