Duchenne Clinical Trials & COVID-19

With the Coronavirus impacting many facets of day to day life, PPMD recognizes the concern from many in the community in regards to the potential impact on Duchenne clinical trials. Last week, FDA issued a guidance document to sponsors (drug companies) about COVID-19. FDA guidance documents provide the FDA’s current thinking on a given topic.

Each sponsor is in process of figuring out alternative plans (if warranted) for dosing and monitoring patients in trials during the COVID-19 pandemic.  Changes to current trials (also known as protocol modifications) may be required due to COVID-19 illness and/or control measures. You should expect to hear from your clinical trial site on how dosing and monitoring will proceed. For trials yet to enroll, there may be delays to recruitment.

PPMD is working with companies to ensure all participants are kept informed of changes to the study and monitoring plans that could impact them. PPMD has requested community facing information from companies regarding trials which some have already provided (see updates below).

If you are having trouble reaching your trial site for more information please contact rachel@parentprojectmd.org

Download Family-Friendly Summary of FDA Recommendations >

Updates from Clinical Trial Sponsors & Approved Drugs

As more families begin to self-quarantine, work & school from home, and drastically change day-to-day routines, questions are arising about what it means if you or your child are receiving medication or treatments from a specific company or participating in a clinical trial. PPMD has reached out to our industry partners and asked for updates. We will continue to update this list as more information becomes available.

Catabasis

Italfarmaco

  • March 27, 2020: Italfarmaco shared an update with the community regarding givinostat clinical trials and COVID-19.

NS Pharma

  • March 23, 2020: NS Pharma, Inc. shared an update with the community responding to questions about how COVID-19 may be affecting ongoing studies of viltolarsen, the recently launched Expanded Access Program (EAP) and review of the viltolarsen New Drug Application (NDA) by the FDA.

Pfizer

PTC

ReveraGen

  • March 23, 2020: ReveraGen shared an update with the community regarding the Vamorolone trials and COVID-19.

Santhera

Sarepta

  • March 19, 2020: Sarepta Therapeutics provided an update addressing questions from the community regarding COVID-19, including updates on current clinical trials and accessing approved therapies.

Solid Biosciences

  • March 30, 2020: Solid Biosciences Inc. shared an update with the community regarding the IGNITE DMD clinical hold and COVID-19.