How Can Real-World Evidence Be Used to Expedite Long COVID Treatments?

The challenge with traditional trials

For people living with Long COVID, the pace of research often feels painfully slow. Traditional clinical trials, while essential, are also rigid, expensive, and difficult for patients to access. 

For patients who are home- and bed-bound, traveling to a study site may be impossible - meaning that trials may not be able to recruit a study population that’s truly reflective of those living with this disease.

On top of that, many pharmaceutical companies have hesitated to invest, saying there isn’t yet a strong enough evidence base about Long COVID’s mechanisms. That leaves the small research community to shoulder the work of building the foundation—and progress has been incremental.

Why real-world evidence matters

The FDA’s Real-World Evidence (RWE) rules provide a new pathway to approval at the FDA.  Instead of relying solely on long and costly clinical trials, RWE uses data from medical records, patient registries, wearables, insurance claims, and even real-time patient reports. This makes it cheaper and faster to gather meaningful information about what treatments are helping.

Patients are already experimenting with therapies and sharing their results—sometimes on social media. These stories bring hope and can even hint at promising directions for research. 

But anecdotes alone aren’t enough to convince regulators like the FDA or pharmaceutical companies to act. By systematically collecting this data in a scientifically rigorous way, we can begin to turn lived experiences into actionable evidence.

FDA’s evolving stance on RWE

The FDA has begun to embrace RWE as a valid tool for expanding access to therapies. One example is Blinatumomab (Blincyto®), a leukemia treatment. While it was initially approved through clinical trials, additional real-world data later helped expand its indications to include a broader patient population.

This shows how RWE can bridge the gap between early patient experiences and large-scale adoption, allowing more people to benefit from effective treatments.

How Long COVID Labs is contributing

At Long COVID Labs, we want to apply the same approach to Long COVID treatments. Our team is building a patient registry—an IRB-approved, standardized platform for patients who want to contribute their data. This registry will allow us to capture what’s already happening in the community:

• Patients trying combinations like monoclonals and antivirals (such as Paxlovid).
  
  
• Individuals experimenting with off-label treatments under physician supervision.
  
  
• Outcomes and patterns that could help reveal which therapies deserve formal study.
  
  

By collecting and analyzing this information in formats that meet FDA standards, we aim to build an evidence base strong enough that regulators and pharmaceutical companies can’t ignore it.

Our goal

Right now, most Long COVID patients access treatments off-label, which requires doctors to take on additional risk. This creates uneven access and leaves many patients without options. Our goal is to change that.

By generating irrefutable real-world evidence, Long COVID Labs hopes to accelerate the approval of effective therapies for new indications. The lived experience of patients is already pointing the way forward. 

We’re creating a Patient Registry to transform the experiences of patients who are trying treatments right now (including those who are home- and bedbound) into real data that will change minds at the FDA and pharma companies.

Conclusion

Our team knows that Long COVID patients have been waiting far too long for answers. By harnessing real-world evidence, we can elevate the voices and experiences of patients into rigorous, actionable science.  

We believe the Real World Evidence approach can bridge the gap between lived experience and regulatory acceptance—helping accelerate safe, effective therapies to the people who need them most.

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