RECOVER-TLC Updates

Putting Patient Needs at the Center of Research Efforts

Many individuals, caregivers, and providers with lived experience have provided input to drive RECOVER-TLC efforts since our September kickoff. These insights will help us identify pressing needs that could impact future clinical trial design.

The Patient-Led Research Collaborative, a group of researchers and others with Long COVID and associated illnesses, highlighted two keys needs:

Include large platform trials and smaller experimental trials

Platform trials provide generalizable data, while smaller trials allow for extensive exploration of biological factors and hypothesis testing. Many individuals and groups recommend starting with smaller trials to explore various mechanisms of action and following with larger validation trials to generate evidence for safe and effective interventions for broader adoption.

Prioritize curative, accessible interventions

A focus on curative interventions will ensure effective treatments are made accessible to all patients, with scalability and affordability beyond study participants. Input compiled by the PLRC, in concert with other input received through the FNIH therapeutics submission portal, supports that combination therapies may be needed, and patient duration of illness should be a key factor in trial design, focusing on those who have been ill for over a year.

Additional input from those with lived experience

Other input highlighted that since Long COVID has different stages, trial designs should address immune, inflammatory, and other markers that change over time, as well as post-exertional malaise, which must be carefully integrated into studies. Other factors such as medications, comorbidities, and phenotypic differences should be tracked, and comparator groups like ME/CFS, POTS, and post-Lyme should be included.

Many patient-focused groups stress that more patient engagement is needed in research, with extensive involvement in decision-making processes and a focus on understanding factors that affect symptom severity, including illness duration, seasonal changes, and triggers like viral reactivation.