The RP HealthCast is back! In our season two premiere, we speak with a scientist, researcher, and medical journalist about the devastating effects experienced by “long-haulers” — a growing group of people who still suffer from COVID-19 symptoms months after being infected.
Natalie: And I think what the world really needs to know is that for many people, COVID-19 is so much worse than the flu. For some people, COVID-19 turns into a debilitating chronic illness that we don’t understand yet, that we don’t have any treatments for, that is primarily invisible. And, you know, they’re having a hard time getting support from family members who don’t really understand what they’re going through. They’re having a hard time getting time off of work that they desperately need to feel better because rest is one of the most important things for this illness. It’s going to be, you know, a huge number of people and a very large percentage of those will have these long-term health problems. We need to support them now.
Jeffrey: Welcome to the RP HealthCast. Science, Innovation, Life. One story at a time. And I’m your host, Jeffrey Freedman.
Jeffrey: Coming up on our first episode of season two, we’ll be discussing the devastating effects of COVID-19 long-hauler syndrome and how it’s affecting millions of Americans.
Jeffrey: Dr. Anthony Fauci has said that the next health crisis our country may face, may be dealing with COVID-19 long haulers. In this episode, we’ll answer a couple of questions related to this such as what it means to be a long hauler? And what are these patients going through? Now to help answer these questions, we have several experts lined up for us to speak with. We have a medical researcher; Dr Natalie Lambert of the University of Indiana School of Medicine. We have a scientist, Dr. Mari Mitrani, the Chief Science Officer of Organicell Regenerative Medicine. And we have a medical journalist, Heather McKenzie of Biospace. Now let’s start with what is a long hauler? I talked to Dr. Natalie Lambert, associate research professor of medicine at the University of Indiana School of Medicine.
Natalie: Well, exactly how to define you know, who is a long hauler and who isn’t is something that is still very much for up for debate and part of it is because we only have about a year’s worth of data to understand what the long term symptoms are, and what the health impacts are, but we’re starting to zero on some particular things. So first of all, you know, if you look at the CDC’s website, it says that if you have a mild case of COVID you could expect to recover in about two weeks. So, it starts to tell us that people are taking longer than two weeks to feel better. They’re starting to get into that long haulers zone. From what I’ve seen is that, most of the people that I’m collecting data on they’ve been sick for actually many, many months. People are starting to settle out around perhaps after about 21 days. We could say that things haven’t resolved like we would expect for a viral illness and people are now long haulers. I think that we’ll have, you know, a medical definition soon, but to me, if it’s been over a month and you’re not getting better from COVID you are definitely a long hauler.
Jeffrey: Now that we have a better understanding of the disease. I wanted to speak with people that are actually on the front lines of finding a solution for these patients. I spoke with Dr. Mari Mitrani, the Chief Science Officer at Organicell Regenerative Medicine in Miami Florida. Organicell was recently identified by a number of leading publications as a pioneering biotech in this area and they’re working at the forefront for a therapy for long haulers. Dr. Mitrani, we’ve heard that you and Organicell are working on a therapy for a long hauler syndrome. Can you please tell us a little bit about the program?
Mari: We’ve developed this drug. We’ve been working many years in the biological or stem cell regenerative medicine space and we’ve been able through all of these years, manufacture a drug that can be consistent and that can actually have results in different things. So we’ve been – before the pandemic came, we were working with lung injury models and our work for COPD or the which is in adult problems where the lungs just start to degenerate or start to die little by little. So, that has been our focus in Organicell for many years besides the lungs, we’ve also been trained to pain or osteoarthritis, but the lung in the specific we’ve had many models with the BPD – bronchopulmonary dysplasia. So, those were our preclinical trials that led us into what we were able to file for COVID specifically, this last year in 2020.
Jeffrey: It’s interesting as we learned so much about COVID and the signs and symptoms that the patients have. Now, it seems that this syndrome has so many disparate symptoms. Now, how can one therapy address all of the symptoms?
Mari: Well, very interesting. Thank you, Jeffrey, for asking this. The protocol that was approved by FDA for our therapeutic, is an intravenous application. When you are putting a drug intravenously, you’re putting it in the entire system in the bloodstream, right? So, even though all of our therapy is centered to modulate the genes through the microRNA for the acute respiratory distress syndrome that COVID develops, we also have seen that the rest of the organs suffered this super inflammatory cascade and it’s so unique, little do we know about this virus? It’s only been one year and the whole medical and scientific community keeps learning day in and day out. First, understand what the acute infection was. I think we are all working towards finding new therapeutics, the preventative side of the vaccine and now, we are learning about the aftermath.The aftermath that is super different in every individual because the immune system reacts to that virus differently and it not only reacts in the lungs. We are, and I think throughout the years we will be coining this kind of viral infection as a multi-organ infection. So, depending on the specific individuals that immune system will react – totally specific for that Individual on the immune system. So, some people only experience symptoms in the lungs. So, you have a cough. Some people only have diarrhea, for example, they don’t have any of the upper respiratory and interestingly enough, we are working with cardiologists that are seeing twenty to forty percent of those patients – they are finding problems or echocardiogram findings in the heart that are not normal. So, imagine we’re talking about the heart, the lung, there’s digestive problems, neurological problems as well. We’ve seen these long hauler group of people that are experiencing fatigue, and fatigue that is an on-set already diagnosed – there’s a name coined already for this kind of problem. So, Jeff it is very very interesting what we’re finding, what we keep investigating in, researching, because this viral infection is not that we are treating the virus itself. We are going to treat the aftermath of what our soldier – our immune system is reacting to this virus.
Jeffrey: Right. Right now, you’re still in early FDA trials and I get that, so we can’t discuss that but can you give us a case study of maybe what you’ve seen in one of your patients because I know you’ve done some emergency I&D work.
Mari: Yeah, so as soon as we got the approval for our trial, our placebo-controlled double-blinded trial early in April. We were able to submit many emergency or compassionate use I&D’s. These are specifically for single patients, where we can treat the patient under FDA approval and we were able to submit and get approval for eighteen different cases. From those eighteen cases, we have four that are approved for long haulers specifically and we were able to understand how our drug will potentially be able to work in these cases. Inflammatory reaction or overreaction of the body setting in different organs is what we are really trying to target in to see. So, our work in Organicell is to apply for this future broader trials, even though we have information on single patients, the goal is always to get bigger trials ongoing and that is our goal for this first quarter of 2021.
Jeffrey: Right. So, since you’re currently finishing up your initial clinical trial and your Phase 1 trials, how can patients get access to this therapy? When do you think you’ll be much broader in national trials?
Mari: Well, as of right now we are accepting those emergency cases where only physicians can request this kind of trial. So, have the physicians from the patients reach out to Organicell directly, to do those emergency cases but sooner we will be able to start enrolling for the long hauler trial specifically. Right now, we are enrolling in two different trials for the acute phase of COVID which are the mild cases and then moderate to severe cases. So, that’s where we are sitting and what we are willing to see in the future.
Jeffrey: Organicell’s work seems very promising. But just as there’s a need for more than one vaccine. I’m sure there will be a need for multiple therapies for post-COVID issues as well. To better understand what other long hauler therapies might be out there. I spoke with Heather McKenzie, a medical writer for Biospace. Heather’s been covering the pandemic for Biospace and has provided in-depth reporting on long hauler syndrome. Now Heather, it’s been reported that there may be up to two-and-a-half million patients in the US with post-COVID issues. What have you found in your reporting both here in the states and globally?
Heather: Yeah, and that does not surprise me. I’ve heard so many people, you know talk about this and you know, there are so many different symptoms. I was actually just speaking with a young entrepreneur from Stanford, the other day who was trying to gain awareness for the long haulers cause. His name is Rob Carlo Ramirez and he mentioned that he had a couple of young family members die from COVID but his sister was lucky and she beat it but now she’s dealing with this long-haul COVID syndrome. And he said she’s feeling a sense of real hopelessness because it’s been going on for about six months. She got it early and last summer and now it’s just it just keeps happening. So, symptoms like fatigue and depression, and even just muscle weakness. There was this one person who was basically a bodybuilder and he can still barely jog, and it’s been three months. So, it’s just really messing people’s lives up, turning them upside down.
Jeffrey: Yeah, it really is and while speaking with Dr. Mitrani, at Organicell and about their open therapy. I know you did some research. What else is out there? Is there anything currently in the market to help these people or in late-stage development?
Heather: We could say late stage. It’s really early stage. I feel like we’re still in the very early stages of this space – of this emerging space and the ones who are trying to break into it are really spinning off treatments that were originally intended either for another condition. Like everyone was doing with the vaccine and in 2020, but this time, they are spinning off treatments for acute COVID that were used in the ICU, and in different hospitals and now they’re trying to translate them to a long COVID because this is going to be the problem of 2021, and hopefully not too much further, but you never know. And some of those companies that I came across a couple of were – in an article I wrote on Christmas Eve. There’s one company called Puretech and I spoke with their Chief Innovation Officer, Dr. Michael Chen and they have LYT100. Which is an anti-fibrotic and anti-inflammatory oral small molecule, and they’re hoping that it can treat all of the residual lung fibrosis or lung scarring that happens with long COVID. So, that’s currently in a Phase 2 trial, that they launched already at the beginning of December I believe it was December 3rd, and they are going to see what happens with that, and I’m actually looking to speak with them later this week on a follow-up article to see what – where they’re where they are going with that two months later.
Jeffrey: It’s interesting. All right, so that’s definitely a different approach and everybody’s looking at different ways to now help these long COVID-19 patients as you said as opposed to the acute COVID patients. Now, you’ve spoken with a couple of them you mentioned the entrepreneur and his company and his family. Have you spoken with any other patients or know about some of their other concerns?
Heather: Yeah. I don’t want to mention any names here but the main thing that keeps coming up seems to be the lasting fatigue and just the muscle weakness and they are not being able to go back and live your life. I read one stat from the CDC, it was based on a phone call and it said that one in five young adults 18 to 34, three weeks after – after their case resolved. They still weren’t able to go back to functioning normally. Those are the people, we’re not really concerned about getting it that much, right? We’re more concerned about our parents and our grandparents getting it, but if we get it, it’s going to overhaul your life for a little while.
Jeffrey: It certainly seems to be, and the stories that we’re hearing are quite traumatic that these are life-changing issues for these people. Now, based on your research. What do you want to tell our listeners that either had long hauler syndrome or have loved ones that are affected by it?
Heather: I would tell patients people who are dealing with these people who have family members to keep trusting the biotech Industry because I really think they’re working hard on this. Just like what happened last year when the biotech and life sciences industry, in general, came together and found a vaccine in nine months. That was miraculous. I mean, that’s just that doesn’t happen but it did happen and there are different drugs – most of them seem to be in development for the lung fibrosis, the lung scarring but there are actually, there’s another one, Cytidine out of Vancouver Washington has a drug called leronlimab, and it goes against the cytokine storm. So, that you know, an overpowering way to overboard immune response, and that’s something interesting because I hadn’t seen a lot of other ones who were actually going against something other than just lung disease. And there’s another company, Bionano, who has created a diagnostic instrument for analyzing genomic DNA that could tell us why some COVID patients get sicker than others and why some people’s symptoms linger. This company I just talked to last night called Bionano. They’re just really interesting. They have this diagnostic instrument. It analyzes the genomic DNA and they did a study. Thirty people who had severe COVID and they found that all thirty had a duplicate – a gene duplication. And that was always making them so sick.
Jeffrey: I’d like to thank our Guest today; Dr. Natalie Lambert of the University of Indiana School of Medicine, Dr. Mari Mirani, the Chief Science Officer of Organicell Regenerative Medicine and Heather McKenzie of Biospace. Thank you all for giving us a well-rounded perspective of what it means to be a long hauler and what these patients are actually going through.
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For more information about Long-hauler’s please see: Therapeutics for ‘COVID-19 Long-Haulers’ Exploding onto the Scene as 2020 Ends | BioSpace