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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The COVID-19 pandemic has led to many rapid changes in health care and beyond since it began in 2020. For example, adaptations set in motion by the public health emergency declaration, including emergency authorization for tests and treatments, telehealth access, and expanded Medicaid, have become commonplace. With the emergency declaration due to end on April 16 with a possible extension until mid–July, patients, providers, payers, and regulators are preparing to face continued challenges.

As a driver of change, the overall pandemic experience will itself have longer-lasting impacts. Clinical trials are now likely to be decentralized, thereby making them accessible to patients in broader and more diverse geographic locations (See Topics to watch). Patients themselves, particularly those experiencing post-COVID conditions (or Post-Acute Sequelae of COVID-19 [PASC]), continue what some call a “revolution in medical research” by asking questions that new clinical trials will be designed to answer.

One patient with post-COVID symptoms outlined ­4 questions for both research and policy: 1) Why are there no diagnostics for microclots, which seem to be associated with post-COVID conditions, but are not detected in standard lab work? 2) Why is there still no public health warning about the risk of post-COVID conditions? 3) Why haven’t post-COVID treatment trials begun? and 4) What is the plan to support the long-term disability needs of post-COVID patients?

Accelerated Adoption of Decentralized Clinical Trials Due to the COVID-19 Pandemic

At a Glance

  • Decentralized clinical trials (DCTs) use technology and local health care providers to provide investigative treatments to patients in their home communities. They might help expand patient pools and expedite clinical research.
  • DCT adoption began before the COVID-19 pandemic. Travel and operational restrictions due to the COVID-19 pandemic have accelerated a shift toward DCTs.
  • Adaptation of DCTs requires robust data acquisition and management platforms, careful consideration of patient privacy protections, and guidance for how this data might be used.
  • The FDA has recently released draft guidance for the use of digital health tech (DHT) in clinical trials.

Combination Regdanvimab (Regkirona; CT-P59) and CT-P63 to Treat Mild to Moderate COVID-19

At a Glance

  • Combination regdanvimab (CT-P59) and CT-P63 is an inhaled monoclonal antibody therapy being investigated to treat adults with mild to moderate COVID-19.
  • The treatment is intended to bind to and neutralize SARS-CoV-2, thus preventing the virus from binding to and entering human cells, furthering infection.
  • The treatment is inhaled, causing the virus to be neutralized in the mucus of the airways and eliminated as the body clears this mucus, thus preventing local infection.
  • Its developer, Celltrion, has submitted an investigational new drug application to the FDA to start a global phase 3 trial investigating the treatment. The anticipated enrollment is 2200 patients with mild to moderate COVID-19.

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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: April 25, 2022

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