Expanded Access

In the US, one way for patients to receive new and experimental treatments is through the FDA’s expanded access program. Expanded access is a way for patients with a serious or life-threatening illness to try a drug or other medical product, outside of the clinical trial setting.

Many countries have expanded access programs, sometimes referred to as compassionate use. While we at LCTI are based in the US, we hope the information we share here will be helpful to all.

To qualify for expanded access in the US, your physician submits an application to the FDA, as well as the pharmaceutical company that manufactures the drug.

Each pharmaceutical company has its own policies in regards to expanded access. While some companies do not participate, others do. Each sets their own terms and qualifications - for example, some companies will only consider expanded access requests for a drug which has passed a Phase I trial.

If there’s a drug you’re interested in, we urge you to speak with your physician about applying for expanded access.

While we can’t say whether a particular drug or treatment is right for you, we do want our readers to have the information they need to make empowered decisions.

Our perspective is that clinical trials for Long Covid have moved too slowly, and that those of us living with the condition deserve treatment as soon as possible.

If you and your doctor believe there is a medication that could benefit you, and is worth the potential risk of side effects, we urge you to look into expanded access and making your voice heard.

At LCTI we’re collecting information on potential treatments and clinical trials.

We share the stories of patients using off-label and unapproved medications to add to our shared knowledge base of what might help.

To learn more about Expanded Access, visit the FDA’s Resource Section for Patients.

If you have used an antiviral, monoclonal antibody, or immunotherapy for Long Covid, please let us know!

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