McGill University Health Centre begins phase III trial for its COVID-19 anti-inflammatory drug
An affordable decades-old drug has been reformulated and repurposed to treat COVID-19 patients.
Research & Development
MONTREAL — A global phase III clinical trial sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC), in partnership with Canadian start-up Pulmonem, begins an innovative treatment to reduce and possibly prevent the development of severe pulmonary inflammation caused by the COVID-19 virus. The clinical trial will test the use of PULM-001 in patients in the early stages of COVID-19. The is one of very few phase III clinical trials for COVID therapies to obtain approval from both the U.S. Food and Drug Administration (FDA) and Health Canada.
PULM-001 is a decades-old, oral antibacterial that also has well-recognized anti-inflammatory properties. It has been used to treat infectious diseases such as malaria, lupus, HIV and many other inflammatory infections. The repurposed drug will be administered to symptomatic adults recovering at home to lessen lung inflammation. This inflammation causes complications in the lungs that can lead to increased hospital and ICU stays, and even death.
The study will be conducted entirely remotely beginning with patients in Ontario and Quebec followed by six centres in the United States. Thousands of symptomatic (COVID-19 positive) outpatients will be involved throughout the course of the trial.
Patient recruitment is launching in Quebec and Ontario June 28: https://dapcorona.com/en/
The trial is led by Dr. Jean Bourbeau, a senior investigator and Director of the McConnell Centre of Innovative Medicine at the RI-MUHC.
“The vaccines are undoubtedly important, but are not the final answer to this problem. It will be a long time before the whole world is vaccinated, and until then, we need a treatment that is effective against this damaging disease. This medication is inexpensive and has a proven record of safety, and we are confident that it will prevent severe COVID-19 cases.” says Dr. Jean Bourbeau.
The trial is a collaboration between the RI-MUHC, the McGill University Health Centre (MUHC) Foundation and Pulmonem Inc., a Canadian biotech startup. Pulmonem has international manufacturing partnership agreements in place and is ready to produce the new medication for the treatment of COVID-19 quickly and in large quantities.