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Infectious Disease
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Long COVID
Patients Living With Long COVID Offer Insight to FDA
— Agency sought feedback on outcomes that matter most to patients
by Shannon Firth, Washington Correspondent, MedPage Today April 28, 2023
Patients with long COVID and their caregivers shared how the illness has impacted their lives, the treatments they've tried, and their hopes for clinical trials during a virtual public meetingopens in a new tab or window on Patient-Focused Drug Development for Long COVID hosted by the FDA on Tuesday.
Impacts on Daily Living
Jill Anderson, a patient participant, works for a behavioral health community services board in Virginia. Before developing long COVID, she had never had vertigo. Today, she's dizzy all the time.
"I would get up in the middle of the night and take a step out of bed and fall to the floor. It was terrifying how my world was spinning and out of balance," she said.
She has also experienced significant "brain fog," fatigue, and loss of appetite. Anderson currently works remotely on a reduced schedule and is worried she might lose her job.
Another patient participant, Heather Elizabeth Brown, a chaplain and corporate trainer in Detroit, said COVID impacted every major system in her body. "That includes my nervous system ... my reproductive system, digestive, lymphatic, endocrine -- any system you can name has pretty much been affected," she said.
She has had blood clots, lymphedema, fatigue, a stroke, COVID-induced diabetes, high blood pressure, and significant brain fog. During her initial infection, she developed pneumonia in both lungs and had to be on a ventilator for 31 days.
As a corporate trainer, her entire job is built around teaching and communicating, she said. "So having moments of not remembering what I was talking about could be very challenging."
Hopes for Treatment
During the panel discussion focused on treatments, Tammy Wilshire, a patient from the Appalachian Mountains of Pennsylvania, said she had "limited success" with a range of supplements -- vitamins C, D3, B12, and magnesium -- as well as beta blockers for tachycardia, and gabapentin for tremors and worsening fibromyalgia.
Physical therapy showed promise at first, she said, but as its intensity increased, she experienced "crippling fatigue" and a relapse of myalgic encephalomyelitis-chronic fatigue syndromeopens in a new tab or window, a debilitating multi-systemic illness, which forced her to stop.
Angela M. Vasquez, president of Body Politic, a grassroots health justice organization, takes 15 medications, receives weekly infusions of diphenhydramine (Benadryl) and saline, and takes supplements to support "mitochondrial health."
After being reinfected with COVID, she took 15 days of nirmatrelvir-ritonavir (Paxlovid) and found that despite an "extended flare," the medication minimized, to a degree, her cognitive dysfunction and gastrointestinal problems.
Her symptoms also improved following her first vaccine, Vasquez said, and she's come up with a "strict pacing routine" that enables her to work full-time from home, though she has little energy for much else.
A third patient, Daniel Lewis, takes a beta blocker and midodrine for post-orthostatic tachycardia syndrome, and bupropion (Wellbutrin) for fatigue, but each has helped only "a tiny bit."
Asked about their ideal treatments, Wilshire said it would need to reduce her pain and fatigue. Vasquez urged scientists to focus on post-exertional malaise. And Lewis said his "most disabling symptoms" relate to exertion.
Lewis urged FDA officials to expand access to approved drugs that he argues appear promising based on early research, including antivirals, Janus kinase inhibitors, anticoagulants, antiplatelets, metformin, and others.
Other patients described success with Pilates (given the opportunity for strengthening muscles without being physically upright), methylphenidate (Ritalin) for brain fog, supplements, acupuncture, meditation, and other supports from functional medicine doctors.
Shaping Clinical Trials
"Anything that is in person is extensively more difficult, than anything that can be ... done on online," said Liza Fisher, a flight attendant and part-time yoga instructor. In-person clinical trials also add to the cost for participants, many of whom have lost employment and healthcare coverage.
Costs of participating in general are always a factor, Fisher said. In 2021, she contemplated participating in a stem cell trial, but was told by the Houston-based company running the trial that she would have to biobank her stem cells first, which would set her back somewhere between $3,000 and $10,000. Fisher, who was unemployed and receiving disability at the time, quickly dropped the idea.
Fisher also found she was ineligible for another trial because she is currently taking off-label steroids. She also noted that other exclusionary criteria included "activity ranges for vitals," which she said aren't sensitive enough for the long COVID patient population.
As for trials of medications with potential side effects, Fisher said, "To be perfectly honest ... every time I was read a list of side effects, I thought, 'oh, that's my Saturday.'"
When she hears of an intervention or medication in a trial that she thinks could potentially trigger an increase in her symptoms, Fisher considers micro-dosing and slow titration schedules to more carefully assess her reaction, rather than opt out.
As to whether she'd be willing to enroll in a trial in which she might be given a placebo, she said she would, as long as she knew that if the experimental drug or intervention was successful, then she would also have access after the trial was completed.
Another patient participant, Ryan, who chose not to share his last name, said he views a control arm as the most important part of a clinical trial. "Sometimes I'll see a study that's been trialing a medication for 6 months and they've seen moderate improvement, but that's my experience without medication," he said.
Ryan also stressed the need to track biomarkers, such as those measuring micro-clotting, endothelial cell dysfunction, and T-cell disturbances or cytokines, which are tied to immune dysfunction more broadly.
As a logistical matter, Ryan also avoids clinical studies that would require him to drive, because of his brain fog
He is currently enrolled in the RECOVER programopens in a new tab or window at Mount Sinai Hospital in New York City, which is accessible by public transportation.
Asked by FDA officials about outcomes that matter most to patients, Michelle, whose daughter has long COVID and who did not share her last name, said that "being able to tolerate returning to school would be the most meaningful improvement for us."
Other patients, some of whom phoned into the webinar, called for more specific studies of long COVID and women's reproductive health. Others expressed concern over the loosening of mask requirements in healthcare settings, and the number of long COVID patients taking supplements, suggesting that more oversight was needed.
In closing the discussion, Michael Iademarco, MD, MPH, deputy assistant secretary for science and medicine in the Office of the Assistant Secretary of Health, noted that there was a great deal of diversity in the perspectives shared.
"It's a lot to pull together ... but at the end of the day, we have to pull it together, and make some steps forward in the right direction," he said. "And we may not always get it perfectly right, but that's what we're aspiring to do in HHS."
author['full_name']
Shannon Firth has been reporting on health policy as MedPage Today's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team. Follow
1 Comment
For the most part that seems true--for now
But even now--in the S2C area--there is only 1 approved drug that is partially effective and that was EUA just couple weeks ago
The application for Psilocybin is mostly beneficial to therapists doing PTSD and End of Life and other therapies. The dosages have to be accurate, it's science, not just me tripping out at Coachella on the shrooms I grew in the backyard. The results of these therapies are phenomenal and I think Psilocybin is a potential goldmine.
This has ALWAYS been about COVID and obtaining EUA for Bucillamine. Everything else is pretty much a joke IMO. And the need for a new COVID treatment has dramatically subsided....I'm sorry to say. There are lots of 'once promising' COVID small biotechs in the COVID graveyard now.
That’s the problem. What are they going to offer that’s differentiated? Anyone can buy or grow shrooms and micro dose they don’t need any pharma. Besides some here continue to say the fda is corrupt and won’t approve anything from small players.
It’s really a pity and a sham at this point in my opinion
Does anybody have a perspective on Revive's progress with Psilocybin? At this point, this industry is expecting legalization in various States to grow. It is legal Statewide in Colorado and legal in Oregon for medicinal use. I think there will be a strong push over the next three years to legalize Psilocybin and perhaps get corporate control over it. In the meantime it will stay mostly underground, but make no mistake, Psilocybin is magic medicine. How can RVVTF benefit here?
Revive was a long shot since the get go about 3 years ago. Now with covid in the rear-view mirror, it's an even bigger longshot. I would be happy just breaking even at this point but it's highly unlikely.
So I just want to ask all of you something. What the hell are we all doing here?
Making $$ of course......whether it comes in singles, or stacks, its still $$.
Progress forward is my hope
Right there with you. Sooner rather than later.....
Hoping and praying that my 30k loss will turn around.
So I just want to ask all of you something. What the hell are we all doing here? It's a 6 cent stock for christ's sake. You can't tell me it hasn't crossed your minds. You're all very intelligent people......well there was that one guy though.
The covid tests are all BS.
Blue Cross Blue Shield no longer providing coverage for covid tests from providers. Day by day the outlook is more bleak. Why would they cover a drug for mild to moderate risk patients who have no chance of ending up in the hospital anymore? We’ll have to rely on out of pocket coverage?
According to BMT, the Revive BOD have committed to inaction with regards to the demands of the litigious groups.
A few of the key points from the video (4 days ago)...
From Biomedical Trader (BMT)
"We have put forward an experienced executive to join the board, Dave Selkirk."
"We are aware of two groups that want to pursue legal action. I have tried to frame their demands as a win-win situation and we have received acknowledgment that the current BoD will be meeting to discuss."
"There are ways for an experienced executive to move forward even without agreement from the FDA, but these paths to revenue are not feasible without an experienced hand at the wheel."
-----------------------------------------------------------------------------------------------------------------------
Shortly ago, BMT just stated on Reddit that the BOD sent him a letter stating that he didn't need to communicate any further between the litigious groups and Revive but he's not sure what will happen next.
I think several folk’s including BMT question the Ceo leadership and strategy
When your down 90% someone should be accountable
Oh wait blame the fda. I get it
when was the photo taken?
In the Bahamas playing golf
I’m wondering all these time long where is the CEO ?
What can you do, you win some you lose some. Miracles happen, I'll stick around and see if MF can pull a rabbit out of his hat. GLTA
Man sorry to hear that.
Yes life is good even though I am down $20 grand! LOL
I’m good here! Only down $800. Made 4x that here on some tza calls today
Life is good no matter how this ends
Remember the exchange I had here with pumpers explaining why I was wrong that anyone would pay a premium???
Really dumb logic since it was fully subscribed for the $4.3M so investors did in fact "pay a premium".
Seems common sense isnt that common these days.
On another note, currently up between ~60--80% on fresh pile, even after some limited profit taking.
Laughing my arse off???.......Absolutely!!! lololsss
#plank
Laughing my ass off. Remember the exchange I had here with pumpers explaining why I was wrong that anyone would pay a premium???
One of them came back with false info that the offering was at .10. lol
Dude there’s little hope for this to get back to .15 anytime soon imho. Why??? There’s simply no catalyst
The only way it moves up to .15 or beyond is announcement of a partnership or unblinding of data showing efficacy?
DMSB recommending continuing the study also maybe but we all know they don’t have the funding or time for that
My question for this fine Tuesday morning is when and how do we get back to $.15 pps? Undoubtably we will…. based on the most recent $.15 investor offering. I imagine they intend to make more than just $.15 pps off of their investment.
Good for thought…???
I watched the podcast and appreciate the efforts of all involved. I have two thoughts:
1. I am not interested in what I believe to be frivolous lawsuits. We all knew the risks, and I still hold out hope that this can work.
2. I found the part where BMT spoke about partnerships quite interesting. He claims that negotiations are not likely due to RVVT pursuing endpoints of hospitalization when even if the data proves Bucy had none, the world has changed one and a half years later making the data antiquated. He believes that if he was guided by an outside source, a focus would have been more on symptoms for long covid. Then he mentions he may intentionally being misled so after a denial or recommendation of trial continuation by DMSB, RVVTF could be bought at a cheaper price.
He also cites that countries have a stockpile of Pax. These thoughts are troublesome.
ps. I still have hope that if we hit a wall, Bucy as a universal drug will get us back to a green pasture. I'm looking forward to unblinding to see what we have here. Also, MF will not even consider this "Chris" addition.
Recording of the shareholder meeting - Thx BMT
https://www.reddit.com/r/RVVTF/comments/12wxq58/recording_of_the_shareholder_meeting/
Thanks Bluehorse glad they recorded it I think. Wasn't able to be there busy errands etc...
https://www.reddit.com/r/RVVTF/comments/12wqfob/big_thanks_goes_out_to_bmt/?utm_source=share&utm_medium=android_app&utm_name=androidcss&utm_term=1&utm_content=share_button
Been 6 months since my last.one I'm probably at %20 lol. Probably even a little less effective against the Xbb.1.16.. Big need for Bucy if it works like the DD shows :0
How effective are BIVALENT boosters at
— Iris Gorfinkel, M.D. (@DrGorfinkel) April 21, 2023
⤵️ing HOSPITALIZATION / DEATH from
Omicron (includes XBB.1.5) ?
Disappointing findings from NEJM:
2 weeks 67 % effective
10 weeks 44 %
20 weeks 38 %
https://t.co/BgY4jC2HrX
More volume on the Canadian side lately, which is a bit rare.
I just posted a very similar comment on Stocktwits.
Biden tests everyone everywhere he goes while claiming the pandemic is over and ending the public health emergency. This is the person and team that promised us they would actually end the pandemic as thousands continue to die weekly and millions increasingly have long covid.
— Joaquín Beltrán for a Free Palestine (@joaquinlife) April 16, 2023
Hang in there, buddy. I've seen horses finish first without a jockey.
ps. I just realized they are disqualified, but you see my point. lol.
pps. As cash depletes, a partnership is growing more and more likely and more and more imminent.
Personally I now think of MF as the big letdown. Until he proves otherwise.
It is no good owning the best thoroughbred race horse if the Jockey is crap.
gator why not Buc for glutathione?
Glycine and NAC pair to increase Glutathione, Increased Glutathione increases have some dramatic effects on increasing life expectancy and health.
This reference cites a number of YouTube videos on the subject. Dr. Brad Stanfield is an interesting addition to the regular Youtube channels as all his videos are based souly on printed medical studies, and he has no horse in the race.
insert-text-here
Agree. This is the first time we heard it from the big cheese.
The fact that MF mentions partnership more than once in the PR is a positive sign, GLTA!
it's easy to play with percentages - but keep in mind thata 17.5% increase comes after a 66.7% decrease (just speaking roughly of the .15 to .5 drop I could site worse.
agreed I was referring to the letter. A shareholders mtg (scheduled and publicized) wouldn't be a bad idea.
Frank screwed every shareholder due to his incompetence. That’s why people are upset. And now the dsmb will likely tell them to continue which will not help anyone cause we have no money or patients, or they halt due to futility. Either way we get screwed. Not a chance they halt due to efficacy.
Maybe. But I think it is only reasonable that the shareholders can request to have a shareholders/investors call. I don't think that would have created any questionable scenarios, if the call is publicized for all to be able to join.
Just as well, they could have transcribed question & discussions, and made it available to the public. I think if they (RVV) try to use that as an out or way to possibly avoid taking questions from the "angry mob" that is just cherry picking to avoid the tough situations, which then seems to indicate a very disheartening pattern.
Did u see mice and men. We are George.
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Scientific Rationale of Bucillamine
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione 2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs.
| Psilocin Pharma Corp. has developed production solutions for the active compound Psilocybin. Our process encompassed with our intellectual property cover methods of production of Psilocybin based formulations. Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body's own natural pathways of absorption while offering a contemporary approach to consumption. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions. | |
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