The U.S. Food and Drug Administration (FDA) is hosting a virtual public meeting 25 April 2023 on Patient-Focused Drug Development for Long COVID.
This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial.
This virtual public meeting will be conducted with live translation in both English and Spanish.
FDA encourages participants to submit written comments to the public docket by 26 June 2023: https://www.regulations.gov/document/FDA-2023-N-0363-0001 or visit www.regulations.gov and search for FDA-2023-N-0363-0001.
Please visit the U.S. FDA Meeting Information page for more information and Register here for the Meeting on Patient-Focused Drug Development for Long COVID.
1. Which symptoms of Long COVID have the most significant impact on your life? (Examples may include pain, difficulty thinking, fatigue, heart palpitations, recurring blood clots, depression, or anxiety).
2. Are there specific activities that are important to you that you cannot do at all or as fully as you would like because of your Long COVID? (Examples may include reading, sleeping, or exercising).
a. Is there a particular impact of Long COVID (such as need to work a reduced work schedule, inability to complete daily tasks, anxiety, or depression) that worries you? If so, what worries you most?
3. How has your Long COVID changed from original diagnosis to now (have you noticed differences in severity, change in symptoms)?
1. What are you currently doing to treat or manage your Long COVID? (Examples may include prescription medicines, over-the-counter products, nutritional supplements, and other therapies including non-drug therapies such as pulmonary rehabilitation, aerobic exercises, or diet modifications).
a. Has your treatment regimen changed over time, and why?
b. What factors went into your decision making when it came to selecting a course of management for your Long COVID?
2. Would you say your Long COVID today is well-managed? Please explain.
3. Assuming there is no complete cure for your Long COVID, what specific things would you look for in an ideal treatment for your Long COVID?
a. Is there a particular symptom of Long COVID (such as fatigue, brain fog, or loss of sense of smell/taste) that you would prioritize for treatment? If so, which symptom would you prioritize?
b. What would you consider a successful treatment outcome?
1. If you considered participating or have participated in a clinical trial for Long COVID, please tell us about your experience.
a. What factors (if any) of the clinical trial enabled you to participate?
b. What factors (if any) of the clinical trial made it more difficult for you to participate?
2. How would the following factors weigh into your decision if you were considering participating in a clinical trial?
a. The clinical trial intervention (Examples may include side effects of the medical intervention, how the intervention is administered etc.).
b. The logistics of the clinical trial (Examples may include the duration of the trial, whether the trial is fully remote or requires clinic visits, the number of in-person clinic visits required, distance from home to clinic site, or whether you might receive a placebo or not).
3. What outcomes for Long COVID are most important to measure in a trial setting? (Examples may include reduction in pain, brain fog, fatigue, or other aspects; or improvement in your ability to perform daily activities such as reading, sleeping, or exercising)