PCORI Biweekly COVID-19 Scan: All-in-One Test Kit, RLF-100 (Aviptadill) (November 21-December 9, 2020)
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.
Patient-friendly home testing is a growing trend (see Topics to Watch). And a more ambitious move to digitally enabled home treatment appears to be emerging: an Eli Lilly and UnitedHealth Group trial will give patients infusions of the drug bamlanivimab in their own homes. The process starts with a daily questionnaire in a symptom-checking app, followed by an at-home test for volunteers who report symptoms. A pharmacy infusion nurse will make home visits to those who need treatment. See our first COVID-19 scan (May 14-May 27, 2020), in which we forecasted the shift to home testing.
Bamlanivimab has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Giving the drug to people who have tested positive for coronavirus but are feeling mild to moderate symptoms is intended to limit disease severity in patients and the burden on hospitals. However, given the rising number of eligible patients, limited staff to administer treatment, and time required to give infusions and monitor patients for subsequent adverse events, use of this drug might add stress to the health care system in new ways. In addition, uncertainty exists about who could gain the most from the drug (eg, people who have not yet developed antibodies to the virus) and who might be at greatest risk of adverse events (eg, hypersensitivity). The cost of $1250 per dose and high number of eligible patients might also strain the system.
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.
Lucira COVID-19 All-In-One Test Kit, an At-Home Assay to Diagnose COVID-19
At a Glance
- The Lucira COVID-19 All-In-One-Test Kit is the first coronavirus test granted an EUA by the FDA for use in the home setting.
- The test kit costs about $50 per test and includes a single-use, battery-operated testing unit, a nasal swab, a sample vial, and a plastic disposal bag. The test purportedly yields laboratory-quality results in about 30 minutes.
- The manufacturer claims that the Lucira COVID-19 test provided results comparable to an FDA-authorized coronavirus test in 51 samples.
- The test requires a prescription from a health care provider for home use in patients aged 14 years or older who are suspected of having COVID-19. It is also intended for point-of-care settings. Patients testing positive are recommended to self-quarantine and follow up with their health care provider.
The Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc, Emeryville, California) is the first coronavirus test granted EUA by FDA for use in the home setting. It is a low-complexity and portable loop-mediated isothermal amplification assay that amplifies and detects viral nucleic acids. The test requires a prescription from a health care provider for home use in patients aged 14 years or older who are suspected of having COVID-19. The test is also intended for use in point-of-care settings, including temporary screening facilities, physician offices, laboratories, urgent care, and long-term care facilities.
The test kit includes a single-use, AA-battery-operated testing unit, a nasal swab, a sample vial, and a plastic disposal bag. The Lucira COVID-19 package insert claims that its performance was evaluated against an FDA-authorized coronavirus test using 51 samples. Compared to this reference standard, the Lucira COVID-19 test showed a positive percent agreement of 94% and a negative percent agreement of 98%. According to the manufacturer, the test requires a small sample volume to yield laboratory-quality results in about 30 minutes and is expected to cost about $50 per test. Patients who test positive are recommended to self-quarantine and follow up with their health care provider.
Reliable home COVID-19 testing has been sought since the pandemic started, to quickly and conveniently identify infected individuals while limiting exposure to others. Initial comments from ECRI internal stakeholders suggest that the Lucira at-home assay will increase access to testing and might shift COVID-19 management by providing purportedly faster results with comparable accuracy to tests performed at health centers and central laboratories. However, stakeholders noted that the number of samples (51) in the trial evaluating the test was inadequate. Still, as Lucira diffuses, it might reduce demands on testing centers, and testing might extend to airports, long-term health care facilities, schools, and workplaces.
Stakeholders expressed concern that despite Lucira’s $50-per-test cost, frequent and widespread testing might increase costs to the system and worsen disparities for low-income individuals who lack financial assistance. At-home testing requires that people voluntarily report positive results to a provider and that they self-isolate. But some people might not report positive results, fearing social or economic consequences from isolation protocols.
Categories: Screening and diagnostics
Areas of potential impact: Population health, clinician and/or caregiver safety, health care delivery and process, health care disparities
RLF-100 (Aviptadil) to Treat COVID-19–Induced Nonacute Lung Injury and Acute Respiratory Distress Syndrome
At a Glance
- RLF-100 is a synthetic form of human vasoactive intestinal polypeptide (VIP) being investigated as an intravenous or inhaled treatment, either as a rescue therapy for patients with critical COVID-19 (ie, respiratory failure) or for preventing respiratory failure in those with moderate to severe COVID-19.
- Preliminary results suggest that patients treated with RLF-100 had an 81% survival rate compared with a 17% survival rate in the control group at 60 days.
- A phase 2/3 clinical trial in patients aged 12 to 85 years with moderate or severe COVID-19 without respiratory failure is ongoing, with primary completion expected in June 2021.
- In September 2020, the manufacturer submitted an EUA request to the FDA for the use of RLF-100 in patients with critical COVID-19 and respiratory failure who have exhausted all approved treatments.
RLF-100 (Aviptadil; Relief Therapeutics, Zurich Switzerland, and NeuroRx, Inc, Wilmington, Delaware) is a synthetic form of human VIP being investigated as an intravenous or inhaled rescue therapy for patients with critical COVID-19 (ie, respiratory failure) and for preventing respiratory failure in those with moderate to severe COVID-19. RLF-100 purportedly reduces coronavirus replication, inflammation (ie, cytokines), and lung cell damage, as well as increases surfactant production, which is important for normal lung function.
RLF-100 became available through an FDA Expanded Access Protocol (EAP) in July 2020 to patients aged 12 years or older who have critical COVID-19 with respiratory failure. Preliminary data from an open-label prospective study of patients enrolled in the EAP found that the 21 patients treated with RLF-100 had an 81% survival rate compared with a 17% survival rate in 24 patients in the control group at 60 days. A phase 2/3 clinical trial in patients aged 12 to 85 years with moderate or severe COVID-19 without respiratory failure is ongoing, with primary completion expected in June 2021.
In September 2020, NeuroRx and Relief Therapeutics submitted a request for an EUA to FDA for RLF-100 in the same population as covered under the EAP—patients with critical COVID-19 and respiratory failure who have exhausted all approved treatments.
Interim data suggest that RLF-100 might substantially improve survival in patients with respiratory failure. If the developer’s EUA request is granted by the FDA, RLF-100 might be available outside of its EAP soon.
Early feedback from ECRI internal stakeholders suggests that RLF-100 is highly likely to impact patient outcomes if it can significantly reduce death, prevent mechanical ventilation, and/or decrease the time that patients require mechanical ventilation. It would be an important and welcomed treatment option for preventing and treating respiratory failure, a main driver of COVID-19–related death. However, it might not address the full spectrum of COVID-19 symptoms (ie, nonlung symptoms).
By improving patient outcomes, RLF-100 might decrease demands on the health care system for hospital beds and mechanical ventilators. More efficacy and safety data are needed to determine its role in COVID-19 treatment.
Areas of potential impact: Patient outcomes, population health, clinician and/or caregiver safety
We welcome your comments on this Scan. Send them by email to [email protected] or
by mail to: Patient-Centered Outcomes Research Institute, 1828 L Street, NW, Suite 900, Washington, DC 20036.
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.|
Posted: December 17, 2020