New treatment for critically ill COVID-19 patients with sepsis is one step closer to potentially saving lives

LONDON, ONTARIO – It’s a human protein called annexin A5, and it’s being studied as a potential therapy for COVID-19 patients with sepsis.  Annexin A5 is a protein produced inside the human body with unique anti-coagulation (preventing blood clots) and anti-inflammatory properties that could help in the fight against sepsis.

Sepsis is a life-threatening condition that occurs when the body’s response to an infection turns into an overwhelming inflammatory response.  The inflammatory response can cause damage to organs such as the heart, liver, lungs, and even the brain.  Unfortunately, most critically ill COVID-19 patients develop sepsis. “With COVID initially, it is in the airway and then in the lungs, then from there the inflammatory response in fact spreads to the whole body,” says Dr. Qingping Feng, Lawson Scientist and Ivey Chair in Molecular Toxicology at Western University's Schulich School of Medicine & Dentistry. “Sepsis causes major organ dysfunction and carries a high mortality unfortunately.”

“For patients with severe COVID-19 disease, what we see is major respiratory failure in the lungs as the primary site in the body,” says Dr. Claudio Martin, Intensive Care Physician at London Health Sciences Centre (LHSC) and Associate Scientist at Lawson. “When the pandemic started, there was no proven treatment for sepsis, including sepsis as a result of COVID-19. Based on clinical trials during the pandemic, we now use steroids and other treatments to try to help, but the results and effects aren’t dramatic and we see patients who have these treatments and still progress and end up in critical care.”

However, Dr. Feng and his team have found in a pre-clinical study that annexin A5 can inhibit inflammation and improve organ function and survival when treating sepsis.  This discovery was made right here in London and now the research team has launched a clinical trial with critically ill COVID-19 patients at LHSC, using a manufactured form of annexin A5.

Enrollment has begun with the goal to have 60 patients participate in the clinical trial. “Patients are receiving standard treatment and then those enrolled will also receive the annexin,” says Dr. Martin. “It’s a placebo blinded clinical trial, so patients will either get a lower dose of annexin, a higher dose of annexin or a placebo.”

If the clinical trial shows promising results the team plans on expanding into a larger phase three trial with not just COVID-19 patients with sepsis, but other sepsis patients as well. “If in fact Annexin A5 is shown to be effective in sepsis, this will be a huge benefit for society because sepsis is the leading cause of death worldwide,” adds Dr. Feng.

The drug is currently being produced through a partnership with Suzhou Yabao Pharmaceutical R&D Co. Ltd., based in China, Lawson Health Research Institute, and WORLDiscoveries.  “Our long-standing partnership with Suzhou Yabao has enabled annexin A5 drug development to proceed to this point,” says Kirk Brown, Manager of Business Development, Lawson Health Research Institute. “We are now in a unique position through this trial to offer a potential life-saving treatment for this emergent global disease, with the objective of soon expanding to all cause septic patients.”

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