An affordable decades-old drug has been reformulated and repurposed to treat COVID-19 patients. Following FDA and Health Canada approval, the drug has now begun Phase 3 of a North American clinical trial.
After months of preparation, a global Phase 3 clinical trial sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC), in partnership with Canadian startup 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 3 clinical trials for COVID-19 therapies to obtain approval from both the U.S. Food and Drug Administration (FDA) and Health Canada.
Its patient recruitment is launching in two weeks in Quebec and Ontario. By June 28, the clinical trial will begin its test phase that will last 21 days to get affirmation that the drug will help reduce and prevent severe pulmonary inflammation caused by COVID-19.
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The trial is led by Dr. Jean Bourbeau, a senior investigator and director of the McConnell Centre of Innovative Medicine at the RI-MUHC. Bourbeau is a respirologist at the McGill University Health Centre as well as professor and associate member of the department of epidemiology, biostatistics and occupational health at McGill University.
“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,” said Boudreau.
This Canada-led trial could change the course of the global pandemic, especially for developing countries that have little access to vaccines. 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.
Researchers say the main reason for using this drug is that it is extremely inexpensive and will help lower hospitalization for people suffering from the disease. PULM-001 has been used to reduce severe pulmonary inflammation caused by other severe diseases such as lupus and malaria.
The drug is not a replacement for taking the vaccine and researchers say “people with COVID-19 should take PULM-001 after suffering symptoms for seven to 10 days.
“Let’s look at the world, the pandemic is not going to end until the entire world has access to vaccinations or therapies,” said Julie Quenneville, president and CEO of the McGill University Health Centre Foundation.
The foundation has raised $1 million needed to start the trial in Canada. It is now working on raising its goal of $4 million in order to be able to complete its trial in the United States and get cost-effective drugs to those in need.
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