N-of-1 Trials: The Only Hope for Long COVID, Spike Protein Complications, and Vaccine-Injured Patients

Signal-Based Medicine | N-of-1 Trials

The Current Dilemma

The current medical system is failing those suffering from Long COVID and vaccine injuries—patients are gaslit, dismissed, and left to deteriorate without real solutions. The reason? Our healthcare model is built around randomized controlled trials (RCTs), which were never designed for individualized treatment.

What Is an N-of-1 Trial?

An N-of-1 trial is a personalized, single-patient clinical study that aligns treatment based on the individual’s unique biomolecular response. Instead of relying on population-based statistics, this method uses real-time molecular surveillance, patient-specific peptide therapeutics, and adaptive treatment adjustments to achieve true precision medicine.

Unlike traditional one-size-fits-all drug development, N-of-1 trials are built around the patient—tracking their unique exome, transcriptome, and proteome to correct faulty molecular signaling at the source.

We do not have time to wait for mass-scale trials designed for bureaucratic approval pipelines rather than real-world recovery. Lives are deteriorating daily, careers are lost, and families are crumbling. The answer is clear: we need a personalized, adaptive medical model that responds to the patient in real-time—not a slow-moving, industry-driven system.

A Stark Illustration:

Recent breakthroughs in gene-based therapies have demonstrated impressive success in conditions like spinal muscular atrophy, sparking renewed hope for addressing complex neurogenetic diseases. However, many of these interventions are designed to target specific genetic variations, and the rigid structure of traditional clinical trials has created a severe bottleneck in innovation.

Economic and bureaucratic barriers ensure that commercial development is prioritized only for high-prevalence druggable genetic variants— those deemed profitable and feasible for large-scale trials. As a result, countless patients with rare or individualized molecular disruptions are left without viable treatment options, reinforcing the urgent need for N-of-1 trials that bypass these restrictive models and deliver precision-driven solutions in real-time.

Unfortunately, this progress has not extended to Long COVID and vaccine-related injuries, where patients are suffering from Spike-protein-induced immune dysregulation, severe cardiac damage, neuroinflammation, and persistent spike-related organ damage with no viable path to treatment.

The reason is clear: traditional clinical trial models prioritize druggable conditions with large, commercially profitable patient populations while existing N-of-1 trials are still shackled by the same flawed system, failing to deliver the personalized, compassionate care that patients with complex, individualized needs urgently require. The solution is simple: individualized N-of-1 trials must operate independently, untainted by the dysfunction of the current medical research model.

The Catastrophic Failure of RCTs in Chronic Disease

RCTs were designed for standardized drug testing, not complex, multi-systemic conditions like Long COVID and vaccine injuries. These illnesses vary drastically between individuals, yet the medical system continues to force them into rigid study parameters that discard individualized responses.

Why the System Is Broken:

• Deliberate Exclusion of the Suffering – Long COVID and vaccine-injured patients don’t fit neatly into RCT parameters, so they are ignored.

• Slow, Bureaucratic Approval Processes – Years-long trials mean patients deteriorate while waiting for an answer.

• Generalized Data Over Personalized Care – RCTs focus on “majority response,” discarding those who don’t fit the mold.

This isn’t science—it’s systemic neglect.

N-of-1 Trials: Immediate Action

At Neo7Bioscience, we reject this failing system and are pioneering N-of-1 molecular therapeutics—because every patient deserves an individualized approach, not an experimental guess.

Here’s how we do it:

1. Molecular Surveillance for Real-Time Targeting

• We analyze each patient’s exome, transcriptome, and proteome to identify the precise molecular disruptions driving their disease.

• This isn’t speculation—it’s direct evidence of what is broken and how to fix it.

2. Personalized Peptide Engineering

• No more trial-and-error medicine. We create precision-targeted peptides that restore faulty signaling, neutralize inflammatory cascades, and support immune recalibration.

• Unlike mass-market drugs, these peptides are designed specifically for the individual’s biomolecular landscape.

3. Continuous Adaptive Monitoring

• Real-time feedback loops allow dynamic treatment adjustments. There are no longer static, one-size-fits-all approaches—if the body changes, so does the therapy.

• Hybrid AI-driven analysis ensures rapid detection of progress or setbacks, allowing for immediate intervention.

A System Rigged Against Individualized Care

We don’t see this approach in mainstream medicine because it threatens the financial strength of the pharmaceutical industry.

• Precision-targeted treatments mean fewer mass-produced drugs—which cuts into Big Pharma’s profit margins.

• A truly individualized medical system means fewer hospitalizations, fewer unnecessary interventions, and fewer chronic patients dependent on expensive lifelong medications.

• RCT-based gatekeeping ensures only patented, billion-dollar drugs get approval—while peptide and precision small molecule therapeutics remain buried under regulatory red tape.

This system is not designed to heal people—it is designed to sustain an industry. We Can’t Afford to Wait—Patients Are Deteriorating Now

Long COVID and vaccine injuries are not theoretical case studies—they are destroying lives in real-time.

• Patients are losing their ability to work.

• Families are watching loved ones waste away without answers.

• Those who seek help are told it’s all in their heads.

Immediate action is essential to dismantle this failing system!

At Neo7Bioscience, we are bypassing the deliberate delays of the system by implementing N-of-1 trials today.

We Are Not Asking for Permission—We Are Taking Action.

The N-Of-1 Model That Works

Neo7Bioscience’s N-of-1 framework for active disease is straightforward, efficient, and powerful—delivering results in just 10 weeks. From the moment a patient submits a sample, we begin building their molecular surveillance and data expression tailored to their unique disease and tissue type. This leads directly to the design and manufacturing of an individualized peptide drug that is ready for dispensing. Unlike the broken system, our approach is swift, precise, and patient-centric. All participating physicians and clinics operate under HHS/NIH registered IRBs as private clinical study sites for N-of-1 individualizations—ensuring compliance and credibility. This is the future of healthcare, unburdened by the failures of traditional systems.

The future of medicine will not be dictated by outdated RCT models or bureaucratic regulators who refuse to acknowledge the urgency of this crisis. It will be built by those willing to fight for patient-centered solutions that work.

If you are a researcher, clinician, or investor who believes in breaking free from the failed medical model, now is the time to act.

Join us in making a difference—lives are at stake!

Visit www.neo7bioscience.com to be part of the future.

Further reading:

1. https://www.nature.com/articles/s41591-021-01519-y

2. https://jamanetwork.com/journals/jamaneurology/fullarticle/2829260?guestAccessKey=37236d8c-7c7d-4581-b9a3-a0bc7166de92&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamaneurology&utm_content=olf&utm_term=012725&adv=004812881201

3. https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2425