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.

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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.

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.

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.

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: December 17, 2020

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