PCORI Biweekly COVID-19 Scan: Treating Mild to Moderate COVID-19, Hospital-to-Home Programs (May 27-June 9, 2021)
Briefing
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.
The World Health Organization (WHO) introduced a labeling system for SARS-CoV-2 variants that aims to reduce the stigma associated with the tendency to name variants after the place where the variant was first detected. Using the Greek alphabet, this system aims to complement rather than replace the scientific nomenclature designated by the Global Initiative on Sharing All Influenza Data (GISAID), Nextstrain, and Pango.
A recent study suggests that the variant WHO designates as Alpha—now dominant in the United States—might, through a unique mechanism of action, evade the body’s first line of immune defense by dampening the production of interferon. Suggestions that each variant might be lowering immune response in a different way is leading to exploration of new targets for future COVID-19 vaccines.
In the meantime, we are learning much about our current vaccines, as reviewed by Nature. Mainly, we are confirming that they are relatively safe and effective in the real world. Although the current 7-day average of new cases remains at about 14 000, administration of the vaccines has been correlated with decreased death, hospitalization, and case rates. In addition, many cases of COVID-19 are not being treated in the hospital, and new treatments and care plans are needed (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.
AT-527 to Treat Mild to Moderate COVID-19
At a Glance
- AT-527 is an oral drug that inhibits the coronavirus RNA polymerase and is being investigated to treat mild to moderate COVID-19.
- AT-527 is purportedly highly selective for a stable region of the SARS-CoV-2 RNA polymerase and might therefore help treat patients infected with emerging COVID-19 variants.
- The manufacturer is conducting a phase 3, randomized, placebo-controlled trial of 1386 patients with mild or moderate COVID-19 in multiple sites outside of the United States, with an estimated primary completion date of August 2021.
- In the United States, AT-527 is being studied in two phase 2, randomized, placebo-controlled trials, one study of 220 patients with mild or moderate COVID-19 and the other of 190 hospitalized patients with moderate COVID-19.
Description
Current treatments for COVID-19 include the antiviral remdesivir, which has been approved by the US Food and Drug Administration (FDA), and the FDA-authorized spike protein–specific monoclonal antibody therapies. However, access to these treatments might be limited because they require intravenous administration, mostly at health centers with infusion centers. AT-527 might address the unmet need for an oral COVID-19 treatment that patients can take while in isolation to reduce the burden and duration of the disease.
AT-527 (Atea Pharmaceuticals, Inc, Boston, Massachusetts) is an investigational oral medication intended to treat outpatients with mild to moderate COVID-19. It acts by inhibiting the SARS-CoV-2 RNA polymerase, an essential protein that allows the virus to replicate in infected individuals, causing COVID-19 symptoms. The drug is intended to be taken in the early phases of infection to reduce the duration and burden of infection. The manufacturer purports that prophylactic use of AT-527 before or soon after known coronavirus exposure might also reduce transmission and duration of infection.
Although vaccines play a crucial role in slowing the spread of COVID-19, effective treatment options are needed for unvaccinated individuals and vaccinated individuals who develop breakthrough infections. Because AT-527 targets a stable region in the viral RNA polymerase, it purportedly offers antiviral activity against several COVID-19 variants (eg, Alpha, Beta, and Gamma).
In clinical trials, AT-527 is taken orally at a dose of 550 mg twice daily for 5 days. AT-527 is in phase 3 clinical development, with primary completion expected in August 2021. In the United States, AT-527 is being studied in two phase 2, randomized, placebo-controlled trials, with primary completion expected in March 2021 and June 2021. We were unable to find information regarding the potential cost of a treatment course of AT-527.
Commentary
AT-527 is an investigational oral therapy for treating mild to moderate COVID-19. Early and effective treatment with the drug might limit the duration of infection and transmission to others in the community. Broad efficacy against coronavirus might help mitigate the threat of infections due to vaccine-resistant variants.
Initial comments from ECRI internal stakeholders suggest that AT-527 might shift care from infusion centers to a home setting. As an oral drug, AT-527 might also be more accessible to patients than intravenous medications.
Although AT-527’s cost is unknown, it will not incur additional costs associated with intravenous treatment, which could reduce disparities. However, stakeholders were concerned that if the availability of AT-527 were to be limited in its initial rollout, it might still create disparities for patients who live in remote or underserved areas, because of a lack of access or awareness that AT-527 is a treatment option.
- Category: Treatments
- Areas of potential impact: Patient outcomes, population health, health care disparities, health care costs
Hospital-at-Home Programs to Manage Patients with COVID-19
At a Glance
- Hospital-at-home programs offer clinical services to treat and monitor patients with COVID-19 in their homes to reduce mortality rates, hospital readmission rates, and health care costs related to COVID-19.
- These programs vary across health systems but generally incorporate remote treatment and monitoring tools and devices to collect data and safely monitor and manage the trajectory of the illness.
- Studies conducted by Mayo Clinic and Cleveland Clinic show that patients diagnosed with COVID-19 who received in-home monitoring services were less likely to require hospitalization, among patients with confirmed COVID-19.
- Hospital-at-home management programs are intended to use fewer hospital resources and provide a model that can be more responsive to rapid scaling based on need, which might increase efficiency in care delivery and engage patients and caregivers as more active partners in their care.
Description
Delivering patient care at home has emerged as a significant trend amid the COVID-19 pandemic. An analysis of data from the Veterans Health Administration found that patients hospitalized with COVID-19 are at increased risk for serious complications and death. The risk is especially concerning for patients who are vulnerable to complications due to underlying medical conditions.
Hospital-at-home programs have shown promise as a safe and effective alternative for managing noncritical COVID-19 patients with high-risk conditions. A review study showed that in-home hospitals, implemented before the pandemic, successfully reduced mortality rates, hospital readmission rates, and health care costs. These programs have previously demonstrated increases in patient and caregiver satisfaction.
This model was adopted by some hospitals to monitor high-risk COVID-19 patients (eg, older adults, clinically vulnerable groups) using in-home spirometry and oximetry devices. Two health systems, UNC Health and Mayo Clinic, partnered with the health technology company, Medically Home Group, Inc (Boston, Massachusetts), to establish temporary wards in patients’ homes. Medically Home’s hospital-at-home program also provides a virtual command center for clinicians to remotely monitor, treat, and communicate with patients with COVID-19 while the patients remain at home.
A recent study by Mayo Clinic showed that cancer patients diagnosed with COVID-19 who received in-home monitoring were 78% less likely to require hospitalization as compared with cancer patients with COVID-19 who were not in this program. Additionally, results from a Cleveland Clinic home monitoring program also showed a lower risk of hospitalization among patients with confirmed COVID-19.
Commentary
Home monitoring programs might improve patient health outcomes and quality of life while reducing the risk of transmitting COVID-19 infection to frontline health care providers. These programs might reduce costs associated with in-patient care delivery and related transportation costs, especially for underserved patient populations.
Early feedback from ECRI internal stakeholders suggests that the use of home treatment and monitoring interventions could be useful for managing COVID-19 surges and future medical emergencies without incurring costly infrastructure changes to hospitals. Virtual wards could be more readily scaled up or down, depending on the situation. However, the tools and equipment needed could increase health care costs for individual patients. These programs would indirectly offer protection against infections beyond standard personal protective equipment for health care workers; however, if the patient’s health deteriorates, transportation and emergency in-patient hospital services would still be needed.
- Category: Systems and management
- Areas of potential impact: Care setting, costs, disparities, infrastructure, population health outcomes, patient management, treatment models, patient health outcomes
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: June 23, 2021
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