NIH announces long-COVID trials to examine treatments for sleep, exercise disruptions

News brief

The National Institutes of Health (NIH) today announced the launch of four more long-COVID clinical trials, which will examine sleep disturbances, exercise intolerance, and post-exertional malaise. The studies add to six earlier investigations that are part of the NIH's Researching COVID to Enhance Recovery (RECOVER) Initiative.

tired woman on exercise bike
Magdevski / iStock

The newly announced trials will assess potential treatments for the symptoms and will enroll about 1,660 people across 50 study sites, the NIH said. 

Urgent need for answers

Walter J. Koroshetz, MD, who directs the NIH's National Institute of Neurological Disorders and Stroke and co-leads its RECOVER Initiative, said, "When people can't get reliable sleep, can't exert themselves and feel sick following tasks that used to be simple, the physical and mental anguish can lead to feelings of utter helplessness. We urgently need to come up with answers to help those struggling with long COVID feel whole again."

One of the RECOVER-SLEEP trials will test two Food and Drug Administration–approved drugs—modafinil and solriamfetol—to treat people with long COVID who have problems staying awake during the day. Another will test potential treatments for complex sleep disturbances due to long COVID, including melatonin and light therapy.

We urgently need to come up with answers to help those struggling with long COVID feel whole again.

Meanwhile, one of the RECOVER-ENERGIZE trials will examine if a personalized cardiopulmonary rehabilitation program can help long-COVID patients with exercise intolerance, and another will look at structured pacing as potential treatment for post-exertional malaise.

The NIH said all four trials were developed using feedback from the community, which included patient representatives. 

UK announces new national action plan on antimicrobial resistance

News brief

UK health officials today announced a new 5-year national action plan on antimicrobial resistance (AMR).

The 2024 to 2029 national action plan replaces the United Kingdom's previous 5-year plan (2019 to 2024), under which the country saw reductions in the use of antimicrobials in people and food-producing animals, development of improved surveillance systems, and the piloting of a new, subscription-style antibiotic payment scheme within the National Health System. UK officials say the new plan will build on those achievements and contribute to meeting the goals of the country's 20-year vision for AMR.

The plan is organized under four themes: Reducing the need for, and unintentional exposure to, antimicrobials; optimizing the use of antimicrobials; investing in innovation, supply, and access; and being a good global partner. The themes apply to human health and social care, animal health, agriculture, food production, and the environment.

"AMR is not just a matter for clinicians—it is important to work across sectors to help preserve these vital medicines to minimise the impact of AMR," UK Chief Medical Officer Chris Whitty, CB, DSc, said in a government press release.

Strategic outcomes

Strategic outcomes within the four themes include developing a "whole systems approach" to infection prevention and control and management; increasing public education and engagement on AMR; strengthening surveillance and antimicrobial and diagnostic stewardship; prioritizing development of new antimicrobials, diagnostics, and vaccines; and maintaining Britain's role as a global leader on AMR.

"We have to work together, across the world, with those countries that need action the most, to make progress and contain AMR," said Dame Sally Davies, UK Special Envoy on AMR.

Online platform aims to share personal stories about antibiotic resistance

News brief

A new online platform that aims to raise awareness of antimicrobial resistance (AMR) through storytelling was launched yesterday.

Global AMR Diary logoCreated by the Partnership to Fight Infectious Diseases and backed by the World Health Organization (WHO) and other health groups, The Global AMR Diary will collect the stories of patients, parents, providers, and others affected by drug-resistant bacteria, with the ultimate goal of raising public awareness and shaping policy to address the looming public health crisis. 

"WHO has been sounding the alarm on antimicrobial resistance for decades, but many people still don’t feel it can affect them personally," Danilo Lo Fo Wong, of the WHO Regional Office for Europe, said in a press release. "The global AMR community needs to find other ways to communicate this message clearly. Personal stories can break the silence and bring the impact of AMR closer to home."

The importance of 'impactful narratives'

The launch coincides with a new communications campaign—"AMR is invisible. I am not"—from the WHO Task Force of AMR Survivors. The campaign features stories from survivors and advocates, along with media and social media toolkits.

The website was launched in tandem with the publication of Diary of a Dying Girl by Mallory Smith, who died of a resistant Burkholderia cepacia infection in 2017. The hope is that Smith's story will encourage others to share their experience and build the case for coordinated action.

"Global health leaders have long been gathering impactful narratives of those affected by AMR," said Smith's mother, Diane Shader Smith. "The Global AMR Diary brings these stories together in a shared commitment to address one of the most daunting health and humanitarian challenges of our times." 

ECDC warns of surge in pertussis cases in Europe

News brief
Bordatella pertussis
Dan Higgins / CDC

European countries are experiencing a surge in pertussis (whooping cough) infections, according to a report today from the European Centre for Disease Prevention and Control (ECDC).

After a few years of limited circulation related to the COVID-19 pandemic, nearly 60,000 pertussis cases have been reported in European Union/European Economic Area (EU/EEA) countries from January 2023 to March 2024. That's a nearly 10-fold increase compared with 2021 and 2022.

Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis and spread through the air. ECDC officials note that while pertussis is an endemic disease in the EU/EEA, larger epidemics occur every 3 to 5 years, even in countries with high vaccination coverage. Similar case numbers were seen in 2016 (41,026) and 2019 (34,468). Waning immunity and decreased natural boosting in the overall population during the COVID-19 pandemic may also be playing a role.

Calls for higher vaccination coverage

In 17 EU/EEA countries, infants under the age of 1 year had the highest incidence of pertussis, while six countries saw the highest reported incidence in adolescents aged 10 to 19 years. The overall risk is assessed as high for unimmunized or partially immunized infants aged 6 months and younger. 

ECDC officials are encouraging countries to achieve and sustain high vaccination coverage.

"Vaccines against pertussis have proven to be safe and effective, and every action we take today shapes the health of tomorrow," ECDC Director Andrea Ammon, MD, MPH, said in an ECDC press release. "We have a responsibility, as parents or as public health professionals, to protect the most vulnerable group from the deadly impact of this disease."

ECDC officials are also calling for countries to inform health professionals about the epidemiology and clinical presentation of pertussis in their area, continue surveillance of pertussis, and employ risk communication on the disease and on the importance of vaccination.

FDA postpones advisory committee meeting on next COVID vaccines

News brief

The US Food and Drug Administration (FDA) yesterday announced that it has changed the date of its upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) from May 16 to June 5, during which the group will discuss and make recommendations on the strain or strains to include in 2024-25 COVID vaccines.

vaccine manufacturing
solarseven/iStock

In an X post, the FDA said the new date will allow more time to obtain surveillance data and other information so that the group has the most up-to-date information for making its recommendations. The agency added that it doesn't expect that the date change will hamper vaccine availability for the fall.

Current vaccines target the XBB.1.5 variant, but JN.1 has become the dominant strain. The World Health Organization (WHO) COVID vaccine advisory group recently met and recommended a switch to a monovalent (single-strain) vaccine containing the JN.1 antigen.

However, scientists have been tracking a steady rise in JN.1 offshoots that have two added spike mutations, nicknamed the FLiRT (F for L at position 456 and R for T at position 346), which may give them more immune-evasive properties. In the United States, for example, the proportion of KP.2, which has the FLiRT mutations, recently topped the parent JN.1 strain. 

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