Peter Staats, MD, MBA, FIPP, Chief Medical Officer of the National Spine and Pain Center talks about how the GammaCore Sapphire CV device is being used in the fight against COVID-19.
How is GammaCore being used in the fight against COVID-19?
Dr. Staats: GammaCore Sapphire CV was recently authorized by the FDA for use in patients with COVID-19. It has a specific authorization which allows it to be used at home or in a healthcare setting by a patient or healthcare provider. It is also thought to be used for the acute treatment of patients with asthma and reduced airflow that is not responsive to more conservative or other medication management.
This would be not necessarily be the first resort, but a last resort.
Dr. Staats: I do not know about a last resort, but this is something that can help people breathe and may have some advantage in helping a patient’s long-term recovery from the disease.
How long ago did it get the FDA emergency use authorization?
Dr. Staats: On July 10th, the FDA authorized the emergency use authorization for use in patients with COVID-19.
How exactly can this device help the patients and what does it do to the body?
Dr. Staats: This device was developed 15 years ago to help patients breathe when they had status asthmaticus and difficult airway breathing. We started studying this in animal models and later studied it in humans. We showed that it could help people breathe with asthma and status asthmaticus COPD and then we learned during the early study that it is effective against headaches. We went through a process to get it FDA approved for headaches, but I never forgot the benefits that we started with, which is helping people breathe. On the way there has also been a 20-year history of science looking at blocking cytokines. So, with patients having an exceedingly difficult time breathing, and the cytokine storm that everybody had been talking about, we filed with the FDA in April. They rapidly authorized this therapy, and on July 10th of this year we received the authorization letter from the FDA allowing us to talk about this.
So, the device itself sends pulses to the vagus nerve. How does that help with the immune system?
Dr. Staats: The vagus nerve is the command-and-control center of a lot of different things in the body. When I was an anesthesiologist, the vagus nerve was something that I did not really understand. It was sort of in my way when I was placing central lines in people or trying to help with an anesthetic or surgical procedure. But the vagus nerve is important because it controls a lot of functions in the brain. It also controls a lot of functions in the viscera (gut) and the various other areas of the body. One of those areas is the spleen, and there is the cholinergic anti-inflammatory pathway which can be activated with vagus nerve stimulation. There has been robust literature for about 20 years looking at stimulating this nerve to turn off inflammation.
So, with COVID-19 how long would patients need this for it to be effective?
Dr. Staats: So, with helping people breathe right away what we have found is when patients place the device on their neck and stimulate for two minutes on either side of the neck almost immediately people can feel an improvement in their ability to breathe. That is like a bronchodilator that someone might get an inhaler with but instead of getting an aerosolized agent that is potentially spreading the virus, this goes to the nerves and then opens up the lungs immediately.
Talk a little bit about the trials going on.
Dr. Staats: There are two investigator-initiated trials going on across the world right now. The first is in Valencia, Spain. As you recall, before the United States got hard hit, it was hitting Europe and we discussed it with the President of the Spanish section of the International Neuromodulation Society. He started running a study early on, which was a randomized controlled trial. Here in the United States, savior two is being done at the Allegheny Health Network, and they are also doing a randomized controlled trial on hospitalized patients looking at the ability to improve breathing overall.
And the results so far?
Dr. Staats: I do not have the results yet but the way these studies are done is they are randomized controlled, and I cannot have access to the data until we hit certain time periods and a certain number of patients have been enrolled. We must wait until those numbers are hit and then we can tell you whether this is better than randomized control or not.
How much better does it help patients breathe?
Dr. Staats: In early studies done a long time ago their work of breathing, which is a metric that patients use when they have asthma, their FEV1 (force expiratory volume in one second) all were significantly improved in the early studies pre-COVID-19. What I am finding is patients are telling me that they feel their ability to breathe is significantly better. One patient sent me his pulse oximetry of it going from 91 to 95 over a very short course with stimulation and that’s important because the pulse oximeter reading is a measure of the amount of oxygen that is getting into your bloodstream.
Right now, what hospitals are currently using it?
Dr. Staats: I do not have the full list of hospitals that are currently using it. Part of the issue is there is a lack of awareness out there. Right now, the FDA has authorized very few therapies. It had authorized Remdesivir, which people have heard of then they pulled it back, and then they reauthorized it again, and I am not sure where it is today. Plasma filtration systems, and GammaCore Sapphire CV are therapeutics of this. They have authorized several personal protective equipment, and mechanical ventilator type of things. But in terms of therapies that can be used specifically to help a patient, there are very, very few, and GammaCore Sapphire CV is one of the few therapies.
How can patients at home get access to it?
Dr. Staats: This is a prescription device. The patient’s physician can go on to the website, find a way to prescribe this electronically and the companies will ship it directly to the patient’s home. Also, if a patient is hospitalized with COVID-19, the physician can write the prescription and the company will ship it directly to the patient at that time.
Would the patient need to have COVID-19 for sure before the doctor can prescribe it to them?
Dr. Staats: That is an important point. The FDA authorized this for known or suspected COVID-19. If the physician is concerned that the patient may have COVID-19, this is something that the physician can order for them and send to them right away without a confirmed test.
With this allowing them to breathe a little easier, would it mean a faster recovery?
Dr. Staats: If you cannot breathe, you cannot recover, and this allows people to breathe much more effectively right away.
If they are doing this at home, do you think that will limit their need to go to the hospital or be placed on a ventilator or respirator?
Dr. Staats: We are studying the role of this device in affecting the need to go on a mechanical ventilator. We believe that we may be able to alter the course of the disease such that, if you can breathe better, you will not need to go on a mechanical ventilator.
Any results yet from the trial in Spain?
Dr. Staats: They are just slowly enrolling. Fortunately, in Spain the number of patients who have COVID-19 but unfortunately, they are coming back now. So, we may have some information soon.
What do you believe this means for the fight against COVID-19?
Dr. Staats: As a scientist I think it is really an important new tool for patients, but this is not the only thing we should be thinking about with COVID-19 patients. First off, do not get sick. Do not forget all the things that Anthony Fauci and others have been saying about avoiding contact. This is one of very few therapeutics out there that we have in our fight against COVID-19. In fact, this is the only one that I am aware of that we can use in the home health setting with known or suspected COVID-19 by a physician or patient.
Does the patient need anything else, like potential breathing difficulties, or just COVID-19?
Dr. Staats: That is at the discretion of the physician. The FDA authorization is for known or suspected COVID-19 for adult patients to be used in the home or health care setting in patients with asthma, exacerbation of their asthma and reduced airflow. So, if the physician believes they are not able to breathe well enough, this would be something that would be considered.
How soon would they be able to get it to their home?
Dr. Staats: We can ship it that day and it could be there the next day.
Is it covered by insurance?
Dr. Staats: We think it will be covered by most insurances since this is one of the core treatments that we have today authorized by the FDA for the treatment of COVID-19. So, we believe insurance should be covering this.
Anything I did not ask you that you feel people should know?
Dr. Staats: The FDA commissioner during a pandemic has a special pathway that he or she can use to get new therapies available to patients in an emergency. This pathway requires there be evidence of a benefit for the patient’s safety and a uniqueness. This device clearly had some evidence of a benefit. It is tremendously safe with a long history of use in the United States for other indications and has an exceptionally good safety profile. And, of course, it is unique because there is nothing else like this today.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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