Petition to McMaster University, the Hamilton Integrated Research Ethics Board, the Faculty of Health Sciences, and the funders of the FALCON study.

McMaster University has launched the Fatigue in Long COVID (FALCON) clinical trial (ClinicalTrials.gov ID: NCT07697261), which compares the commercially branded Lightning Process with activity pacing in people living with Long COVID.

We are calling on McMaster University to pause recruitment for the FALCON trial until an independent scientific, ethical, and patient-led review has addressed serious concerns regarding the study's design, transparency, participant protections, conflicts of interest, commercial relationships, and use of objective outcome measures.

This is not a call to stop Long COVID research.

It is a call for better Long COVID research.

Why this matters

More than six years after the pandemic began, millions of people continue to live with Long COVID.

Patients still face enormous barriers to diagnosis, treatment, disability support, and recognition. At the same time, Canada has committed relatively limited resources to Long COVID research compared with the scale of the crisis.

Every Canadian treatment trial matters.

Every research dollar matters.

That is why many patients are deeply concerned that one of Canada’s leading medical institutions has chosen to study a commercially branded program focused on changing how people think about, interpret, and respond to their symptoms, rather than prioritizing research into the underlying biology of this disease.

Our concerns

1. Long COVID is increasingly understood as a complex biomedical illness.

Research from around the world continues to identify abnormalities involving the immune system, viral persistence, the vascular system, autonomic function, metabolism, inflammation, and other biological processes.

Psychological support can be an important part of living with any chronic illness.

However, psychological support is fundamentally different from testing an intervention whose central premise is that changing thoughts, beliefs, language, and behavioural responses may substantially improve the illness itself.

Many patients fear this risks reinforcing the psychologizing of Long COVID—a narrative that has already contributed to stigma, delayed diagnosis, barriers to disability benefits, and dismissal within healthcare.

2. The study appears heavily dependent on subjective outcomes.

The FALCON trial is open-label, meaning participants know which intervention they receive.

Its primary outcome appears to rely on self-reported fatigue.

This raises an important scientific concern.

A program specifically designed to change how participants perceive and describe their symptoms is being evaluated largely by asking participants whether those symptoms have changed.

Patients deserve to know:

• Will participants objectively regain physical function?
• Will they be able to walk farther?
• Return to work?
• Care for their families?
• Increase daily activity without worsening?

Objective improvement—not simply changes in symptom reporting—should be central to evaluating any treatment.

3. Canada’s scarce research capacity should be used wisely.

Canada already conducts relatively few Long COVID treatment trials.

Patients continue to wait for meaningful biomedical therapies while researchers around the world investigate:

• viral persistence
• immune dysfunction
• endothelial injury
• autonomic dysfunction
• metabolic abnormalities
• biomarkers
• antiviral therapies
• immune-modulating treatments

With so little Canadian research capacity available, many patients are asking:

Why is this where our limited resources are being directed?

4. Greater transparency is needed.

The Lightning Process is a commercially branded program delivered by trained practitioners.

Patients deserve complete transparency regarding:

• who is funding this trial;
• the total value of the grant;
• any licensing or trademark fees;
• payments made to practitioners;
• commercial relationships;
• potential conflicts of interest;
• and whether anyone connected to the Lightning Process participated in designing the study.

Transparency should be expected—not requested.

We respectfully call on McMaster University to:

1. Pause recruitment until an independent scientific, ethical, and patient-led review has addressed concerns regarding the study's methodology, transparency, participant protections, commercial relationships, conflicts of interest, and objective outcome measures.
2. Publicly disclose all funding sources and commercial relationships connected to the trial.
3. Publish the full study protocol and statistical analysis plan.
4. Clearly explain what objective measures—not simply self-reported questionnaires—will determine whether participants have truly improved.
5. Demonstrate how the study will detect post-exertional symptom worsening, deterioration, adverse events, and loss of function.
6. Meaningfully involve people living with Long COVID in reviewing the study’s design.

Long COVID patients deserve better.

People living with Long COVID have spent years fighting to have this illness recognized as real.

They deserve rigorous science.

They deserve transparency.

They deserve meaningful biomedical research.

Most importantly, they deserve research that does not risk returning this illness to a framework centred on patients’ thoughts and behaviours before its underlying biology has been adequately understood.

McMaster University has an opportunity to lead.

We urge McMaster University to pause recruitment until these concerns have been independently reviewed and publicly addressed, ensuring that any future Long COVID research meets the highest standards of scientific rigor, transparency, participant safety, and accountability.

Please sign this petition if you believe Long COVID patients deserve research that is transparent, scientifically rigorous, and worthy of the people whose lives depend on it.