Patient’s Life Saved by Small Trial led by Hudson Health’s Dr. Tom Pitts’ Investigation into Eculizumab for Severe COVID-19 Cases

Apr 25, 2020 | ARDS, Coronavirus, COVID-19, Cytokine Storm, Eculizumab, Leading Sites, Site Success, Site Watch

Patient’s Life Saved by Small Trial led by Hudson Health’s Dr. Tom Pitts’ Investigation into Eculizumab for Severe COVID-19 Cases

Amy De Vos was fighting for her life. The 45-year-old out of a small town called Troy, Ohio (near Dayton) was in critical condition—spending 29 days in Upper Valley Medical Center with COVID-19. As her conditioned worsened in the hospital, her doctor, Dr. Eleina Mikhaylov, reached out to a neurologist out of New York and a Wright State alum—Dr. Tom Pitts—who had studied previous coronaviruses. He uncovered that something known as a “compliment” was attacking patient’s lungs and formulated a defense. This was in the form of a complement inhibitor called Eculizumab or Soliris. As it turns out, the FDA approved this approach on five patients—and Amy De Vos represents the first person to come out of this clinical trial using the rarely-used drug used to treat respiratory illness.

TrialSite News offers brief synopsis of this incredibly inspiring story. Thanks to this small and obscure FDA approved trial (led by Dr. Tom Pitts), as well as smart and sharp thinking on the part of her physician, Ms. De Vos is alive and well today!

What Happened here?

A 45-year-old woman out of Troy, Ohio contracted COVID-19 and became severely ill. Amy was taken to the ICU, ready to be intubated due to the incredibly severe conditions. She was intubated a day later after arriving in ICU and placed on a ventilator for 16 days. Dr. Eleina Mikhaylov entered the picture at this point recalling for local press Dayton 247 Now that “we were called to see patient who had a seizure that I was told was infected with COVID-19 and who was in critical condition.” A note that Amy does have lupus as well, and it is speculated that this could have influenced the rapid decline in condition.

During these 16 days, Ms. De Vos’ conditioned worsened, becoming so severe that according to a story produced by reported Megan O’Rourke with 247Now, Amy’s family started literally saying their goodbyes—she was near death due to COVID-19 complications.

How long was Amy in the hospital?

She was in the hospital for 29 days.

What decisions were made to help save her life?

While Amy’s COVID-19-caused conditioned worsened while being treated at Upper Valley Medical Center, Dr. Eleina Mikhaylov was aware this was fast becoming a life and death situation. Dr. Mikhaylov, a graduate of Wayne State, was aware of a neurologist out of Wright and now practicing in New York—Dr. Tom Pitts, who had been researching coronaviruses and had received FDA approval for the emergency use of an obscure drug use rarely for respiratory illness. Dr. Mikhaylov, thinking on her feet as Amy’s condition became critical (and her family was saying goodbyes), reached out to Dr. Tom Pitts, the Wayne State alum. 

Enter Dr. Tom Pitts

Dr. Tom Pitts had received FDA approval for a small study involving 5 critically severe COVID-19 patients. Dr. Mikhaylov had recalled some research Dr. Pitts was undertaking associated with coronaviruses. Dr. Pitts, through his research, had figured out something called a “complement” was attacking people’s lungs and his study concerned how to defend against this. According to Dr. Pitts, “I went ahead and looked at the armamentum and found we have a compliment inhibitor that I use regularly called Eculizumab or Soliris.” Dr. Mikhaylov suggested they move forward.

The Rest is history

Amy De Vos’ condition rapidly improved after the administration of Eculizumab, and she is back with her husband and three kids today—although reports some memory loss. 

Dr. Thomas Pitts’ Protocol

The FDA approved a small study led by Pitts—this study led Amy’s life. A summary of his approach can be seen here. Hudson Medical issued a press release in February announcing Pitts’ point that although COVID-19 is the provocateur, it is the patient’s own disproportionate immune response which often deals the most devastating (and often fatal) damage.

What is Eculizumab?

Sold under the trade name Soliris (among others), it is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica. For those facing PNH, it reduces the destruction of red blood cells and the need for blood transfusion, but doesn’t appear to affect risk of death. The drug was the first such drug approved for each of its uses, and its approval was granted from small trials. It is administered via an intravenous (IV) infusion.

Eculizumab was developed by Alexion Pharmaceuticals which had a patent until 2017. They started selling the drug in 2007, and at one point it was considered the world’s most expensive drug—by 2019, the drug required an outlay of $409,500 per year for treatment. By 2015, it was considered the fourth most expensive drug in the U.S. on a per person basis.

Lead Research/Investigator

Dr. Tom Pitts is a Board-Certified Neurologist with fellowship subspecialty training in Clinical Neurophysiology from Columbia University Medical Center at New York-Presbyterian Hospital. He also earned a Certificate of Added Qualification in Headache Medicine from the National Headache Foundation. He treats the entire spectrum of neurologic illness and has a personal interest in neuromuscular disorders, especially Myasthenia Gravis.

Call to Action: All across the world, physicians and medical professionals are pulling off heroic feats in an effort to save lives against COVID-19. Make sure to support healthcare efforts in anyway you can.

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