FDA gives emergency green light to blood filter for treating coronavirus
US regulators have given emergency use permission for a device to filter coronavirus patients’ blood in an effort to combat the devastating effects of severe inflammation.
Doctors believe that many of those who die of coronavirus die as a result of the so-called ‘cytokine storm’ – a deluge of inflammation meant to help fight the infection that ultimately overwhelms and damages the body itself.
In an effort to clear some of this dangerous inflammation from COVID-19 patients, the Food and Drug Administration (FDA) has approved Terumo BCT’s blood filtering device.
Still, there are no direct treatments approved for COVID-19, but the hope of US regulators and Terumo is that the device, given emergency use authorization on Friday, will mitigate some of the disease’s most severe effects in patients in the ICU.
US regulators gave emergency use authorization for treating coronavirus to Terumo’s device (picture) that removes blood from a patient’s body, filters out the proteins involved in the life-threatening cytokine storm, and returns the blood, in an effort to combat inflammation
More people in the US have been infected by and died of coronavirus than have been struck by the disease in any other country.
Coronavirus has sickened more than 562,000 Americans and cost more than 22,000 their lives.
Some patients only become mildly ill, but for others – especially older patients and those with underlying conditions – the virus reaches deep into the lungs, triggering pneumonia, a potentially life-threatening form of lung inflammation.
Inflammation is part of the body’s immune response to any pathogen.
When a foreign invader is detected, a wave of immune cells rushes to the site of infection to try to fight it off.
Among the groups of immune soldiers sent to fight infection are cytokines, a varied set of proteins, growth factors and other substances.
WHAT IS THE ‘CYTOKINE STORM’ KILLING COVID-19 PATIENTS?
Devastating lung inflammation triggered by the so-called ‘cytokine storm’ is thought to be what ultimately kills the sickest coronavirus patients.
Cytokines are a group of cells involved in the immune system’s response to injury or infection.
They race to the site of a problem and signal to the body to send more immune cells to mount a defense against a foreign invader.
It’s a crucial part of how the body heals itself – but when it goes haywire it can do lead to devastating damage.
The influx of immune cells causes inflammation which, when persistent, an go awry and start killing cells in the very tissues the immune system is trying to protect
When overabundant signalling cytokine cells stay switched ‘on’ for too long inflammation can continue out of control.
This inflammation overwhelms the lungs of coronavirus patients, sending them into respiratory failure an ultimately killing many of them if this inflammation can’t be stemmed.
Cytokines signal inflammation to ramp up to draw more immune cells to fight the infection.
But when the infection persists, cytokines remain switched ‘on,’ and the immune system keeps deploying more and more inflammation-causing cells, the defenders can misfire, damaging and even killing healthy tissues.
This is the unfortunate route that doctors are seeing coronavirus patients go down.
Lung inflammation becomes so severe that their lungs stop functioning and they require ventilators to breathe for them and deliver oxygen to the rest of the body.
Without a treatment to fight the virus itself, scientists the world over are racing to find ways to put a damper on the inflammation coronavirus triggers, by quelling the cytokine storm.
Terumo’s device might accomplish this by siphoning cytokines from the blood.
It uses a process known as apheresis. The device removes the patient’s blood from their body, splits it into plasma and red blood cells, applies a therapy, then returns the recombined blood to the body.
The method is most commonly used to treat autoimmune diseases by skimming out misplaced antibodies involved in the body’s attacks on itself.
By combining their device with a ‘cartridge’ made by Swiss company Marker Therapeutics, Terumo hopes apheresis can have a similar benefit for coronavirus patients’ runaway immune responses.
‘This partnership offers the potential to develop a unique global solution for treatment of acute respiratory failure in COVID-19,’ said David Cohen, Chairman of Marker, in a press statement.
Doctors at Maimonides Medical Center are also using a blood-related therapy to treat COVID-19 patients by removing their blood, adding oxygen to it and returning it to them when mechanical ventilation isn’t enough to make up for their failing lungs
The device now has emergency authorization for treating any one 18 or older who is in an ICU already, is in or on the verge of lung failure.
‘With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease,’ FDA Commissioner Dr Stephen Hahn said in a Friday press release.
It’s not clear whether or how many COVID-19 patients the method has been tested on, but the emergency use authorization will allow the FDA to collect data on the efficacy of the Colorado company’s treatment method.
Terumo isn’t alone in using blood-related therapies in an attempt to treat coronavirus patients.
In Brooklyn, doctors at Maimonides Medical Center are also removing blood from patients on ventilators and returning it to them after adding oxygen in an effort to make up for the lungs’ inability to oxygenate blood.
Source: Daily Mail | Health News