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Establishing a clinical trial for novel therapies to address long COVID

  • 25 Jul 2024
A black and white photo of a man in a subway station wearing earphones.
Photo: Tired by Jan Jespersen, licensed under CC BY-NC 2.0.

In the midst of another peak in COVID, flu and respiratory viruses, Burnet continues its research into the longer-term impacts of these infections.

Burnet Institute was granted A$274,000 from the Australian Government’s Medical Research Future Fund (MRFF), for its ‘Harnessing effective approaches for long COVID' (HEAL) project to design a clinical trial for the rapid assessment of novel therapies for long COVID.

Long COVID refers to the constellation of longer-term health effects caused by infection with the SARS-CoV-2 virus. It's a complex condition affecting multiple organ systems and can present a wide range of symptoms and conditions.

The trial will be designed by a research collaboration involving consumers, clinician-researchers, scientists, primary care physicians and policymakers.

HEAL is an inception project to design a clinical trial to assess novel therapies to improve care for people living with Post-Acute Sequelae of COVID (PASC) or long COVID. The 12-month project will synthesise current evidence, involving consumers and clinicians in the design.

Researchers will conduct preliminary clinical research and engage with priority communities, including remote and rural residents, Aboriginal and Torres Strait Islander health providers, culturally and linguistically diverse communities and individuals from the LGBTIQA+ community.

Burnet chief health officer for COVID and health emergencies Associate Professor Suman Majumdar is the chief investigator on the grant application. He said there was an urgent need to develop treatment options for people living with long COVID.

"Long COVID can develop in up to 10 per cent of people following acute COVID," he said.

"This is a significant and ongoing burden of illness for individuals and the health system, especially with the high levels of COVID infections and re-infections."

"At the moment, people with long COVID have no proven treatments to help them manage their condition and are living with a chronic illness."

Co-lead of the project Dr Michelle Scoullar, a paediatrician and senior research fellow at Burnet Institute, said the trial is designed to accelerate the identification of evidence-based therapies for long COVID and reduce the impact on people’s lives.

"There are several possible drivers of long COVID. We need to develop medical and non-medical treatments to manage the impacts of the disease, which can be debilitating and prolonged in both adults and children,” she said.

Founder of Clinic Nineteen, a specialist clinic dedicated to long COVID, and project co-lead Dr Emma Tippett said HEAL brought together a large network of clinicians who were currently managing patients with long COVID.

"People are desperate to recover their health and return to their regular lives. Waiting lists have blown out and many people with long COVID cannot even access basic care,” Dr Tippett said.

"This funding gives us hope that we may be able to identify and deliver an effective treatment to improve the quality of life and level of function of people with long COVID."

Zoe Cutcher is an infectious disease epidemiologist with experience in trial design and outbreak investigation with more than two years of personal experience with long COVID, including severe symptoms that profoundly impact daily life.

She offers a unique combination of both professional expertise and lived experience to the study team.

"The study leads have ensured I can contribute meaningfully despite my severely limited capacity, and recognise and value the contributions of priority communities in designing a trial that addresses the lived experience of patients," Ms Cutcher said.

HEAL is a partnership between Burnet Institute, Active Health Clinic, Australian Dysautonomia and Arrhythmia Collaborative, Australian Living Evidence Collaboration, Baker Institute, Clinic Nineteen, Emerge Australia, First Nations Research at SAHMRI, Geelong Long COVID Clinic, Icahn School of Medicine at Mount Sinai, Monash University, University of Melbourne and people living with long COVID.