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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Concerns about a possible “twindemic” of the flu and COVID-19 have surfaced this year following a particularly rough flu season in the Southern hemisphere. Pfizer recently administered doses to the first participants in their phase 3 mRNA flu vaccine study, joining Moderna, whose trial began in June. Pfizer is also seeking an emergency use authorization (EUA) for their SARS-CoV-2 Omicron BA.4/BA.5 bivalent booster for children 5 through 11 years of age.

The potential emergence of further Omicron sublineages or of a Pi variant is adding to these winter concerns. In the hopes of identifying future threats as early as possible, scientists are using wastewater testing to track so-called cryptic SARS-CoV-2 lineages that might be evolving in people with chronic infections.

More data are emerging on neurologic post-COVID conditions (PCC). One year after having acute COVID-19, individuals in the US Department of Veterans Affairs national healthcare databases show an increased risk of many long-term neurologic disorders, both physical (joint pain, myalgia, neuropathy, hearing and vision impairments) and mental (e.g., memory problems, depression, anxiety) (see Topics to Watch for a new care model for veterans).

Recent reviews highlight the similarity between PCC and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and outline how few specialists are available to treat such patients. The limited  availability of care and the costs of treating a long-term chronic condition are expected to exacerbate the racial disparities of PCC. For example, one new care model requiring a $99 per month membership fee plus $170 for a 30-minute visit (only laboratory tests are covered by insurance) is available only in California, Oregon, Washington, Florida, and Arizona.

Post-Acute COVID-19 Syndrome Coping and Recovery (PACS-CR) Psychotherapeutic Intervention to Treat Veterans with Post-COVID Conditions

At a Glance

  • As many as 1 of 3 people who have acute COVID-19 develop post-COVID conditions (PCC), and veterans who have had acute COVID-19 have a 60% increased risk of mental health conditions or related prescriptions.
  • The US Department of Veterans Affairs is investigating a psychotherapeutic intervention, PACS-CR, for use in veterans with PCC.
  • The intervention consists of 12 weekly group teletherapy sessions aimed at improving psychological adjustment, resiliency, and coping in patients with PCC, all of which can improve functional status and quality of life.
  • PACS-CR is being investigated in an unphased pilot clinical trial with primary completion expected in January 2024. The pilot study is intended to inform a future large-scale randomized controlled trial.

Preconfigured Decentralized Clinical Trial Modules for Vaccine Development

At a Glance

  • The COVID-19 pandemic accelerated adoption of decentralized clinical trials (DCTs), which use technology and local health care providers to provide investigative treatments to patients in their home communities. DCTs have multiple potential advantages compared with traditional, centralized clinical trials, such as increased patient enrollment, quicker development, and cost savings.
  • However, barriers to the uptake of DCTs remain, such as the upfront cost of new software, determining how to use it effectively, ensuring data security and patient privacy, managing the risk of trial protocol deviations, and collecting large amounts of data.
  • Software company Medable recently announced it is now offering preconfigured, vaccine-specific DCT modules, designed to enable faster vaccine trials, better site and patient experiences, and expedited data delivery.
  • The preconfigured DCT modules might decrease vaccine trial deployment times from more than 12 weeks on average to as little as 5 weeks.

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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: October 7, 2022

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