Just Talked To A Friend And Found Out His Wife Was Hospitalized For Four Months With C***d
Jan 5, 2022 17:27:40 #
He got it and didn't even know he had it, he had what he thought was a head cold so he talked to the VA doctor and asked about decongestants, they suggested a C***d test, and even though he thought there was no way because he had had both shots, he got one and found out he was positive. Then his wife got it from him and was hospitalized for four months, she was on a ventilator four or five times, the last ones through a trachea hole so it wouldn't do permanent damage. She had pneumonia, a stroke, and is still on oxygen at home although she is trying to wean herself off of it. She's been home for a month after four months in the hospital.
It can k**l even those who are fully v******ted...
It can k**l even those who are fully v******ted...
Jan 5, 2022 17:47:38 #
Jan 5, 2022 17:56:45 #
woodguru wrote:
He got it and didn't even know he had it, he had w... (show quote)
It's good to see you are finally seeing the bigger picture. These "v*****es" are NOT working. Two very obvious, obvious examples are (1) V******ted can get C***d, its variants and any other v***ses that come around just as easily (maybe more so, since their i****e s****ms are c*********d) as unv******ted people; and (2) The fact that there are now four booster shots and talk of there being a need for monthly shots for the foreseeable future, if not the rest of life, for v******ted people is a sure sign that they are a failure. We were never told that booster shots, possibly for life, were going to be necessary.
Jan 5, 2022 20:47:46 #
woodguru wrote:
He got it and didn't even know he had it, he had w... (show quote)
The v*****e is what's k*****g you poor dumb Goobers.
And the hospitals have become devolution extermination centers.
The die off of v******ted people has begun and the coming year will be sorrowful beyond measure.
Jan 5, 2022 21:28:24 #
There are treatments that have been available for the past two years (TWO YEARS) and the FDA has been slow walking them.
Here is an article on a Doctor who managed to get the treatment and raves about the result but it has been slow walked by the FDA because they are pushing the v*****es.
Knowing this treatment is out there is one of the reasons I have not taken the shot. I told my son, a medical doctor, if I were to get C***d, please contact the manufacturer of this drug and get me treated with it.
The government is not interested in therapeutic treatments so many people in this coutnry have needlessly died.
Here is the article:
Emergency Treatments Needed Now!
By Dr. Jacobo Elgozy, DO
Jan 5, 2022
Imagine you have a loved one hospitalized in intensive care facing death from C****-**. All approved therapeutics were tried. Time has run out and you have been told to prepare for the worst. Your doctor advises there is one last drug to try, a natural protein that has been safely used in early trials and shown signs of effectiveness in rescuing patients from ventilators when all else has failed. The National Institutes of Health is doing a global study to prove its effectiveness.
Unfortunately, the Food and Drug Administration will not give E*******y Use A***********n because the medicine showed only a 92 percent chance of being effective, rather than the “magic 95 percent” that is the traditional gold standard for approving drugs.
I was that patient. I contracted C***d while serving on the front lines of a hospital, caring for my own patients. My story has a happy ending only because my lifelong friend, an ICU doctor, moved heaven and earth to cut through the red tape and obtain the medicine for me with the FDA’s permission. I was especially lucky that the medicine was being tested at a nearby hospital and the pharmaceutical company immediately rushed an emergency dose to my bedside. I was as close to death as one can be, treated not only with a ventilator but also with extracorporeal membrane oxygenation (ECMO), which few survive. By the time I got the medicine and began to recover, the hospital was already preparing me for a lung t***splant.
Unfortunately, most Americans are not as fortunate as I was. Each day another 1,400 people die anonymous, lonely deaths in the ICU, isolated from their loved ones when some number could be saved by emergency use medicines. The nation awaits confirmation of a new FDA Commissioner at a perilous time for public health as C***d continues to ravage the world.
Congress passed E*******y Use A***********n to empower the FDA to give doctors, patients, and families access to medicines that “may be effective” when all else has failed. For the first year of the p******c, EUA decisions were overseen by the Commissioner’s office. Promising therapies were given a chance to show their effectiveness, or lack thereof, for the benefit of patients and families. Some early EUA medicines, such as remdesivir and tocilizumab, went on to prove their benefit in definitive trials and became approved drugs, while others failed and were withdrawn. That sort of trial is exactly what Congress and the American people intended in the face of an unrelenting enemy.
Unfortunately, in the absence of a confirmed FDA Commissioner, EUA decisions have been relegated to the traditional review groups that apply more rigorous measures of safety and effectiveness for permanent new drug approvals. FDA is listening to the voices of statisticians, not to the voices of doctors, patients, and families.
The medicine I received, vasoactive intestinal peptide called Zyesami, was shown in a clinical trial to give patients a substantially higher likelihood of getting off the ventilator to a 92 percent degree of certainty and to double the odds of surviving the ICU to a 99 percent degree of certainty. Of course, the statistic I care about most is that within days of receiving the medicine, my lungs began to function again. Within weeks, I was back home with her.
Of course, a single experience such as mine cannot drive a drug approval. However, there are multiple reports in the media of seemingly miraculous recoveries such as mine. The data on Zyesami were sufficiently promising that Dr. Francis Collins, the director of the NIH, recently identified our medicine as one of a handful still under consideration by NIH in global trials from among more than 600 candidate medicines it initially considered. Dr. Anthony F***i has similarly briefed the White House and Congress on the medicine, and he has invested substantial taxpayer funds in a global trial to test its effectiveness. As the nation awaits the results of the definitive NIH trial, it seems like common sense that we try medicines that “may be effective” provided they are safe.
Eventually, miraculous new pills may decrease the likelihood that patients will be hospitalized. In the meantime, the medicine that saved me may be the last, best hope for patients in the ICU who have exhausted all approved therapies. Today, physicians, patients, and families are currently denied this last chance, unless they resort to circumventing the FDA through Right to Try laws. Few physicians and hospitals have the courage to do so, even in the face of family demands. Fortunately, I had a doctor who would not take “no” for an answer and a small pharmaceutical company that happened to have enough medicine for me at a nearby clinical trial site.
For more people to have access to lifesaving drugs like this one, we need Congress to restore the original legislative intent of the EUA law. Restoring EUA decisions to the Commissioner’s Office would allow those decisions to be made by a Congressionally confirmed senior member of the Administration who is willing to take prudent risks on behalf of the American people. It is also important for the commissioner’s door to be open to the voices of patients, families, physicians, and nurses, so that life and death decisions are not calculated simply by the numbers.
I ask the FDA to take measured risk with time-limited approvals and other tools that enable us to gain real world experience with medicines that may be safe and lifesaving. At a time when too many of us will see empty chairs around the holiday table, we must be willing give our loved ones one last chance at life.
– Dr. Elgozy practices internal medicine and pediatrics in Miami Beach, Florida and contracted C***d while serving on the front lines of the p******c. He has no financial interest in any pharmaceutical company.
Here is an article on a Doctor who managed to get the treatment and raves about the result but it has been slow walked by the FDA because they are pushing the v*****es.
Knowing this treatment is out there is one of the reasons I have not taken the shot. I told my son, a medical doctor, if I were to get C***d, please contact the manufacturer of this drug and get me treated with it.
The government is not interested in therapeutic treatments so many people in this coutnry have needlessly died.
Here is the article:
Emergency Treatments Needed Now!
By Dr. Jacobo Elgozy, DO
Jan 5, 2022
Imagine you have a loved one hospitalized in intensive care facing death from C****-**. All approved therapeutics were tried. Time has run out and you have been told to prepare for the worst. Your doctor advises there is one last drug to try, a natural protein that has been safely used in early trials and shown signs of effectiveness in rescuing patients from ventilators when all else has failed. The National Institutes of Health is doing a global study to prove its effectiveness.
Unfortunately, the Food and Drug Administration will not give E*******y Use A***********n because the medicine showed only a 92 percent chance of being effective, rather than the “magic 95 percent” that is the traditional gold standard for approving drugs.
I was that patient. I contracted C***d while serving on the front lines of a hospital, caring for my own patients. My story has a happy ending only because my lifelong friend, an ICU doctor, moved heaven and earth to cut through the red tape and obtain the medicine for me with the FDA’s permission. I was especially lucky that the medicine was being tested at a nearby hospital and the pharmaceutical company immediately rushed an emergency dose to my bedside. I was as close to death as one can be, treated not only with a ventilator but also with extracorporeal membrane oxygenation (ECMO), which few survive. By the time I got the medicine and began to recover, the hospital was already preparing me for a lung t***splant.
Unfortunately, most Americans are not as fortunate as I was. Each day another 1,400 people die anonymous, lonely deaths in the ICU, isolated from their loved ones when some number could be saved by emergency use medicines. The nation awaits confirmation of a new FDA Commissioner at a perilous time for public health as C***d continues to ravage the world.
Congress passed E*******y Use A***********n to empower the FDA to give doctors, patients, and families access to medicines that “may be effective” when all else has failed. For the first year of the p******c, EUA decisions were overseen by the Commissioner’s office. Promising therapies were given a chance to show their effectiveness, or lack thereof, for the benefit of patients and families. Some early EUA medicines, such as remdesivir and tocilizumab, went on to prove their benefit in definitive trials and became approved drugs, while others failed and were withdrawn. That sort of trial is exactly what Congress and the American people intended in the face of an unrelenting enemy.
Unfortunately, in the absence of a confirmed FDA Commissioner, EUA decisions have been relegated to the traditional review groups that apply more rigorous measures of safety and effectiveness for permanent new drug approvals. FDA is listening to the voices of statisticians, not to the voices of doctors, patients, and families.
The medicine I received, vasoactive intestinal peptide called Zyesami, was shown in a clinical trial to give patients a substantially higher likelihood of getting off the ventilator to a 92 percent degree of certainty and to double the odds of surviving the ICU to a 99 percent degree of certainty. Of course, the statistic I care about most is that within days of receiving the medicine, my lungs began to function again. Within weeks, I was back home with her.
Of course, a single experience such as mine cannot drive a drug approval. However, there are multiple reports in the media of seemingly miraculous recoveries such as mine. The data on Zyesami were sufficiently promising that Dr. Francis Collins, the director of the NIH, recently identified our medicine as one of a handful still under consideration by NIH in global trials from among more than 600 candidate medicines it initially considered. Dr. Anthony F***i has similarly briefed the White House and Congress on the medicine, and he has invested substantial taxpayer funds in a global trial to test its effectiveness. As the nation awaits the results of the definitive NIH trial, it seems like common sense that we try medicines that “may be effective” provided they are safe.
Eventually, miraculous new pills may decrease the likelihood that patients will be hospitalized. In the meantime, the medicine that saved me may be the last, best hope for patients in the ICU who have exhausted all approved therapies. Today, physicians, patients, and families are currently denied this last chance, unless they resort to circumventing the FDA through Right to Try laws. Few physicians and hospitals have the courage to do so, even in the face of family demands. Fortunately, I had a doctor who would not take “no” for an answer and a small pharmaceutical company that happened to have enough medicine for me at a nearby clinical trial site.
For more people to have access to lifesaving drugs like this one, we need Congress to restore the original legislative intent of the EUA law. Restoring EUA decisions to the Commissioner’s Office would allow those decisions to be made by a Congressionally confirmed senior member of the Administration who is willing to take prudent risks on behalf of the American people. It is also important for the commissioner’s door to be open to the voices of patients, families, physicians, and nurses, so that life and death decisions are not calculated simply by the numbers.
I ask the FDA to take measured risk with time-limited approvals and other tools that enable us to gain real world experience with medicines that may be safe and lifesaving. At a time when too many of us will see empty chairs around the holiday table, we must be willing give our loved ones one last chance at life.
– Dr. Elgozy practices internal medicine and pediatrics in Miami Beach, Florida and contracted C***d while serving on the front lines of the p******c. He has no financial interest in any pharmaceutical company.
Jan 5, 2022 21:44:53 #
This was another article posted by Doctor Elozy while he was undergoing treatment. Therapeutic Treatments worked but they have been ignored by the Biden Administration.
This Miami Beach doctor recovered from C****-** after taking new drug. This miracle drug has been available since December 2020 (Note: The treatment has been around for two years. Why hasn’t it been in all ICU’s across the country? Bottom Line: “They don’t care about public health!”
BY LYNN MARTINEZ
DECEMBER 3, 2020
MIAMI BEACH, FLA. (WSVN) - A South Florida doctor who was in critical condition after he contracted C****-** is making a remarkable recovery, and he said it’s thanks in large part to a new drug that has shown great promise in clinical trials.
Speaking with 7News on Thursday, Dr. Jacobo Elgozy said he is grateful to be alive.
“All of them were really, really surprised by my recovery. It was a miracle,” he said.
For the first seven months of the p******c, the 47-year-old was the one taking care of patients at Mount Sinai Medical Center in Miami Beach.
Then he became infected with the v***s.
“My lungs were white-out, completely gone, non-functional,” he said.
Elgozy said it was one of the worst cases his doctor has ever seen.
“The journey that I had was really rough, and many times I had my ups and down,” said Elgozy, “because you see yourself not being able to breathe, and having difficulty breathing and getting fatigue.”
It looked like Elgozy may need a lung t***splant. At one point, he was scheduled to undergo a double lung t***splant.
That’s when his doctor thought of RLF-100 (aviptadil), a game-changing drug. A doctor who is leading the trial at Johns Hopkins University is seeing promising results.
“With the drug, we saw a 70% or greater survival,” said NeuroRX CEO Dr. Jonathan Javitt, “but in these patients who have no alternative, who have very little to look forward to, we believe the experience that was seen in Houston and seen now around the country.”
Now, with Elgozy’s recovery, that experience is also being seen in South Florida.
“In a matter of two weeks plus, I recovered like this,” he said as he snapped his fingers. “My lungs started responding like there was no tomorrow. Everybody thinks it was related to the RLF-100 that was given to me, that protected my lungs from any injury or scarring.”
For his wife and family, the recovery was an answered prayer.
“It was the best feeling ever to know your loved one was finally back,” said a family member.
“When I was able to see them and hug them and know that I was coming home to them, it was heaven,” said Elgozy. “It was very overwhelming. I couldn’t stop crying.”
Besides the treatment, Elgozy gave credit to a team of nurses and doctors.
“At least in my book, all of them are angels and heroes. I mean, they would do anything to try to save anybody,” he said.
Elgozy believes more lives could be saved if everyone would follow the advice of the Centers for Disease Control and Prevention.
“Now is not the time to put your guard down. Just, for people, keep your mask on. It’s just a few more months,” he said. “The v******tions are coming out. Things are going to get better. There is no reason why people should die because [they’re] not wearing a mask.”
Elgozy said he is planning to go back to work In January.
Doctors are hoping the Food and Drug Administration will give them e*******y use a***********n to make the drug more widely available to patients who have no other option to get off a ventilator.
This Miami Beach doctor recovered from C****-** after taking new drug. This miracle drug has been available since December 2020 (Note: The treatment has been around for two years. Why hasn’t it been in all ICU’s across the country? Bottom Line: “They don’t care about public health!”
BY LYNN MARTINEZ
DECEMBER 3, 2020
MIAMI BEACH, FLA. (WSVN) - A South Florida doctor who was in critical condition after he contracted C****-** is making a remarkable recovery, and he said it’s thanks in large part to a new drug that has shown great promise in clinical trials.
Speaking with 7News on Thursday, Dr. Jacobo Elgozy said he is grateful to be alive.
“All of them were really, really surprised by my recovery. It was a miracle,” he said.
For the first seven months of the p******c, the 47-year-old was the one taking care of patients at Mount Sinai Medical Center in Miami Beach.
Then he became infected with the v***s.
“My lungs were white-out, completely gone, non-functional,” he said.
Elgozy said it was one of the worst cases his doctor has ever seen.
“The journey that I had was really rough, and many times I had my ups and down,” said Elgozy, “because you see yourself not being able to breathe, and having difficulty breathing and getting fatigue.”
It looked like Elgozy may need a lung t***splant. At one point, he was scheduled to undergo a double lung t***splant.
That’s when his doctor thought of RLF-100 (aviptadil), a game-changing drug. A doctor who is leading the trial at Johns Hopkins University is seeing promising results.
“With the drug, we saw a 70% or greater survival,” said NeuroRX CEO Dr. Jonathan Javitt, “but in these patients who have no alternative, who have very little to look forward to, we believe the experience that was seen in Houston and seen now around the country.”
Now, with Elgozy’s recovery, that experience is also being seen in South Florida.
“In a matter of two weeks plus, I recovered like this,” he said as he snapped his fingers. “My lungs started responding like there was no tomorrow. Everybody thinks it was related to the RLF-100 that was given to me, that protected my lungs from any injury or scarring.”
For his wife and family, the recovery was an answered prayer.
“It was the best feeling ever to know your loved one was finally back,” said a family member.
“When I was able to see them and hug them and know that I was coming home to them, it was heaven,” said Elgozy. “It was very overwhelming. I couldn’t stop crying.”
Besides the treatment, Elgozy gave credit to a team of nurses and doctors.
“At least in my book, all of them are angels and heroes. I mean, they would do anything to try to save anybody,” he said.
Elgozy believes more lives could be saved if everyone would follow the advice of the Centers for Disease Control and Prevention.
“Now is not the time to put your guard down. Just, for people, keep your mask on. It’s just a few more months,” he said. “The v******tions are coming out. Things are going to get better. There is no reason why people should die because [they’re] not wearing a mask.”
Elgozy said he is planning to go back to work In January.
Doctors are hoping the Food and Drug Administration will give them e*******y use a***********n to make the drug more widely available to patients who have no other option to get off a ventilator.
Jan 5, 2022 21:50:16 #
The reason Therapeutic Treatments have been put on the back burner is because someone is making a lot of money in kickbacks in the Federal Government to push the v*****es and not promote any other remedies. Could it be Doctor F***i, Joe Biden, the Democrat Party getting donations for their war chest. Hmmmm!
Your friends wife could have been saved from the consequences of C***d if she were adminstered this treatment. It is effective in all stages of the disease particularly when someone is placed on a ventilator. It's success rate is amazing but the government has not yet approved its use after two full years. The emergency use designation process approval is rediculous.
Joe Biden could have orderd the FDA to issue an EUD based on its merits. But then again. he isnt all that intelligent or he is on the take.
Your friends wife could have been saved from the consequences of C***d if she were adminstered this treatment. It is effective in all stages of the disease particularly when someone is placed on a ventilator. It's success rate is amazing but the government has not yet approved its use after two full years. The emergency use designation process approval is rediculous.
Joe Biden could have orderd the FDA to issue an EUD based on its merits. But then again. he isnt all that intelligent or he is on the take.
Jan 5, 2022 22:11:12 #
woodguru wrote:
He got it and didn't even know he had it, he had w... (show quote)
Then why get "v******ted" when you don't know what it's going to do to you?
What's your game plan with THIS thread, Tali-Wood?
Jan 6, 2022 07:41:51 #
woodguru wrote:
He got it and didn't even know he had it, he had w... (show quote)
Wow... It's like when you get your flu shot and then still get the flu... I think you should start a campaign to force flu shots on the population...
Jan 6, 2022 09:10:50 #
Your friends wife could have been home in a week if the FDA had approved RLF-100 or Zyesami and treated with these miracle therapeutics. Public health suffered for two years while the FDA, Doctor F***i, and Joe Biden sat on their A$$’s. Many of those lives could have been saved. Therapeutics took a back seat to the v*****es which have shown to not be all that effective. So Sad!
Jan 6, 2022 09:41:37 #
tbutkovich wrote:
Your friends wife could have been home in a week if the FDA had approved RLF-100 or Zyesami and treated with these miracle therapeutics. Public health suffered for two years while the FDA, Doctor F***i, and Joe Biden sat on their A$$’s. Many of those lives could have been saved. Therapeutics took a back seat to the v*****es which have shown to not be all that effective. So Sad!
The problem is that if the FDA approved something and put it on the market (like Zyesammi or Ivermectin or HCQ) they would have to cancel out the EUA's they gave to P****r, M*****a and J&J for their expreimental drugs. People were duped into thinking that the FDA has approved P****r's "v*****e", but it's not true. Their original version of the v*****e is STILL under the EUA - NOT approved by the FDA. What was approved was the version that is labeled "Comirnaty", which is still being manufactured and distributed in Europe (mainly Germany to a company called "Biontech") and is not available in the United States now. They don't know when it will be available. Maybe later this year or 2023, who knows. But right now, when they get the P****r shot, they are NOT getting the FDA-approved version. The bottles must be labeled with the word "Comirnaty" on them per the approval letter (attached -see the top of page 2 for labeling instructions).
https://www.fda.gov/media/151710/download?fbclid=IwAR0OuY9hdWzoXhzRU9TvaChLpiOmiWVPdT5Z-KB_93f36xvy7JXfVOyJM-s
Jan 6, 2022 09:46:33 #
Politics should be put aside. Here is the science behind the treatment:
Intravenous Aviptadil for Critical C****-** With Respiratory Failure (C***D-AIV)
Authored byStaff
Updated November 11, 2021
Last ReviewedNovember 11, 2021
In this study, 196 patients who are hospitalized for Critical C****-** infection with respiratory failure will be randomly allocated to Aviptadil administered by intravenous infusion in addition to maximal intensive care vs. maximal intensive care alone. Primary endpoints will be an improvement in blood oxygenation and mortality.
Acute Lung Injury, which triggers Critical C****-** is a known lethal complication of C****a V***s (SARS-CoV-2) infection. Conventional medical therapy, including intensive care and respiratory support is associated with an 80% mortality. Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and admitted to the FDA C****aV***s Technology Accelerator Program.
VIP binds to VPAC1 receptors on the pulmonary Alveolar Type II (ATII) cell. ATII cells comprise only 5% of lung epithelial cells but are critical for oxygen t***sfer, surfactant production, and maintenance of Alveolar Type 1 cells. 70% of VIP binds to this receptor. The Type II cell is also the cell selectively attacked by the SARS-CoV-2 v***s via the ACE2 surface receptor.
Nonclinical studies demonstrate that VIP is highly concentrated in the lung and specifically bound to the ATII cell, where it prevents NMDA-induced caspase-3 activation in the lung, inhibits IL6 and TNFa production, protects against HCl-induced pulmonary edema, and upregulates surfactant production, These and other effects have been observed in numerous animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine, and dogs. In these models, Aviptadil restores barrier function at the endothelial/alveolar interface and thereby protects the lung and other organs from failure.
Aviptadil has a demonstrated 20 year history of safety in phase 2 trials for Sarcoid, Pulmonary Fibrosis, Bronchospasm, and a phase I trial in ARDS. In that phase I trial, 8 patients with severe ARDS on mechanical ventilation were treated with ascending doses of VIP. Seven of the 8 patients were successfully extubated and were alive at the five day timepoint. Six left the hospital and one died of an unrelated cardiac event.
Five phase 2 trials of aviptadil have been conducted under European regulatory authority. Numerous healthy volunteer studies have shown that i.v. infusion of Aviptadil is well tolerated with few adverse effects including alterations in blood pressure, heart rate, or ECG. In addition to published studies of human use, Aviptadil has been used on a compounded basis in certain ICUs for many years in the belief that it preserves life and restores function in pulmonary hypertension, ARDS, and Acute Lung Injury (ALI).
Results
On October 14, 2021, the peer-reviewed results of this clinical trial were published in the Journal of Infectious Diseases and Treatment.
Seventeen of 21 (81%) patients survived to day 60 in the aviptadil treated group compared to 5 of 24 (21%) control patients. In addition to the substantial differences seen for both survival and recovery, the study demonstrated statistically significant advantages in the aviptadil-treated group on two important intermediate endpoints: Respiratory Distress Ratio and Cytokine IL-6.
CLINICAL TRIAL DATA
V*****e:
Zyesami (Aviptadil) Therapeutic
Phase:
Phase ll/lll
Clinical Trial ID:
NCT04311697
MILESTONES
Status:
Completed
Start Date:
May 15, 2020
Completion Date:
February 22, 2021
Still not available in our Intensive Care Units. Our government at work!
Intravenous Aviptadil for Critical C****-** With Respiratory Failure (C***D-AIV)
Authored byStaff
Updated November 11, 2021
Last ReviewedNovember 11, 2021
In this study, 196 patients who are hospitalized for Critical C****-** infection with respiratory failure will be randomly allocated to Aviptadil administered by intravenous infusion in addition to maximal intensive care vs. maximal intensive care alone. Primary endpoints will be an improvement in blood oxygenation and mortality.
Acute Lung Injury, which triggers Critical C****-** is a known lethal complication of C****a V***s (SARS-CoV-2) infection. Conventional medical therapy, including intensive care and respiratory support is associated with an 80% mortality. Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and admitted to the FDA C****aV***s Technology Accelerator Program.
VIP binds to VPAC1 receptors on the pulmonary Alveolar Type II (ATII) cell. ATII cells comprise only 5% of lung epithelial cells but are critical for oxygen t***sfer, surfactant production, and maintenance of Alveolar Type 1 cells. 70% of VIP binds to this receptor. The Type II cell is also the cell selectively attacked by the SARS-CoV-2 v***s via the ACE2 surface receptor.
Nonclinical studies demonstrate that VIP is highly concentrated in the lung and specifically bound to the ATII cell, where it prevents NMDA-induced caspase-3 activation in the lung, inhibits IL6 and TNFa production, protects against HCl-induced pulmonary edema, and upregulates surfactant production, These and other effects have been observed in numerous animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine, and dogs. In these models, Aviptadil restores barrier function at the endothelial/alveolar interface and thereby protects the lung and other organs from failure.
Aviptadil has a demonstrated 20 year history of safety in phase 2 trials for Sarcoid, Pulmonary Fibrosis, Bronchospasm, and a phase I trial in ARDS. In that phase I trial, 8 patients with severe ARDS on mechanical ventilation were treated with ascending doses of VIP. Seven of the 8 patients were successfully extubated and were alive at the five day timepoint. Six left the hospital and one died of an unrelated cardiac event.
Five phase 2 trials of aviptadil have been conducted under European regulatory authority. Numerous healthy volunteer studies have shown that i.v. infusion of Aviptadil is well tolerated with few adverse effects including alterations in blood pressure, heart rate, or ECG. In addition to published studies of human use, Aviptadil has been used on a compounded basis in certain ICUs for many years in the belief that it preserves life and restores function in pulmonary hypertension, ARDS, and Acute Lung Injury (ALI).
Results
On October 14, 2021, the peer-reviewed results of this clinical trial were published in the Journal of Infectious Diseases and Treatment.
Seventeen of 21 (81%) patients survived to day 60 in the aviptadil treated group compared to 5 of 24 (21%) control patients. In addition to the substantial differences seen for both survival and recovery, the study demonstrated statistically significant advantages in the aviptadil-treated group on two important intermediate endpoints: Respiratory Distress Ratio and Cytokine IL-6.
CLINICAL TRIAL DATA
V*****e:
Zyesami (Aviptadil) Therapeutic
Phase:
Phase ll/lll
Clinical Trial ID:
NCT04311697
MILESTONES
Status:
Completed
Start Date:
May 15, 2020
Completion Date:
February 22, 2021
Still not available in our Intensive Care Units. Our government at work!
Jan 6, 2022 14:26:40 #
tbutkovich wrote:
The reason Therapeutic Treatments have been put on... (show quote)
I don't belive in conspiracy theorys about drugs being withheld because someone is making money. I do belive that for a durg to be approved, it must be safe and effective
This takes time to prove.
Jan 6, 2022 14:51:56 #
Aviptadil has been used for many years for erectile disfunction.
Some one discovered that it’s use also destroyed the C***d v***s.
In spite of the extensive historical use for ED use with few minor side effects, it has been slow walked for C***d.
That’s the t***h. Check it out!
Some one discovered that it’s use also destroyed the C***d v***s.
In spite of the extensive historical use for ED use with few minor side effects, it has been slow walked for C***d.
That’s the t***h. Check it out!
Jan 6, 2022 15:42:51 #
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