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Relief Therapeutics’ Peptide Hormone Helped Critical COVID-19 Patients
August 4, 2020
Severely ill COVID-19 patients given Relief Therapeutics’ RLF-100 (aviptadil) experienced rapid recovery in just three days, according to the company and its research partner NeuroRx.
The treatment, a patented formulation of synthetic human vasoactive intestinal polypeptide, works by inhibiting pro-inflammatory cytokines and protecting lung cells targeted by the coronavirus. It has been granted expanded access and a Fast Track designation by the FDA and is currently in an ongoing phase 2/3 trial.
The peptide hormone formulation led to fast recovery of COVID-19 patients with respiratory failure who were given access to the drug under the FDA’s emergency investigational new drug (IND) program.
Patients with critical COVID-19 “were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50 percent or greater average decrease in laboratory markers associated with COVID-19 inflammation,” the companies said.
Houston Methodist Hospital was the first to announce a rapid clinical recovery under the emergency use, the companies said. A 54-year-old COVID-19 patient was taken off a ventilator within four days of being treated with RLF-100. Similar results were reported for more than 15 patients treated under the FDA’s emergency use. — James Miessler
COVID-19
Houston Methodist reports rapid recovery of COVID-19 patients with new drug
HOUSTON – Houston Methodist Hospital is making national headlines after doctors use a new drug to help treat COVID-19 patients.
Methodist was the first to report the rapid recovery of patients on ventilators and those with severe medical conditions after three days of treatment. The drug is called RLF-100, which has been approved by the FDA Emergency Use IND to use at multiple clinical sites.
According to a press release, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.
According to a report, a 54-year-old man who contracted COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days. According to the report, other similar results were seen in more than 15 patients.
The drug appeared to have rapidly cleared pneumonitis, improved blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation, according to the press release.
"No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."
To learn more about the RLF-100, click here.
Copyright 2020 by KPRC Click2Houston - All rights reserved.
ABOUT THE AUTHOR:
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Brittany Taylor
Award-winning journalist, mother, YouTuber, social media guru, millennial, mentor, storyteller, University of Houston alumna and Houston-native.
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Great find tendies...thank you!
Pinks and OTC do not trade in PM/AM.
This might be the breakthrough coronavirus cure we’ve been waiting for
Coronavirus Cure
A ventilator helps a COVID-19 patient breath inside the Coronavirus Unit at United Memorial Medical Center, Monday, July 6, 2020, in Houston. Image source: AP Photo/David J. Phillip
By Chris Smith @chris_writes
August 3rd, 2020 at 10:52 AM
A potential coronavirus cure that can reduce recovery time and prevent COVID-19 complications is now in Phase 2/3 testing.
The drug is called RLF-100 or aviptadil, and it also received emergency use authorization in the US for the treatment of critically ill COVID-19 patients.
RLF-100 has already saved the lives of multiple patients experiencing severe COVID-19 complications, but the companies are yet to publish the scientific data that would show its efficacy and safety.
If there’s one thing we’ve learned in the seven months the world has been fighting the novel coronavirus pandemic, it’s the fact that the novel coronavirus isn’t anything like the flu. That’s what COVID-19 appeared to be in its early days, a new type of flu with similar symptoms that many hoped could be cure with the same drugs. Doctors quickly discovered the new virus was far more contagious than the flu, and that its attack on the body was a lot more complicated than initially believed. The virus affects a variety of organs, not just the lungs, and it can kill people quickly and viciously. Age, sex, and preexisting conditions are significant risk factors, but COVID-19 has also killed younger people who had no previous medical problems.
Moreover, flu drugs don’t work on COVID-19, and that has been an enormous problem. That’s what forced governments to opt for lockdowns in the early months of the pandemic and try to limit the spread of the disease, thus giving hospitals time to treat patients. Pharmaceutical companies have now made tremendous progress when it comes to vaccine research, as well as new therapy ideas. We currently have a few COVID-19 cures that work, including remdesivir, dexamethasone, and blood thinners, but we still lack a breakthrough drug that can significantly reduce recovery time and prevent complications. Some researchers think they’ve already found one such compound that could annihilate the virus and prevent it from killing patients with severe COVID-19 cases, and the medicine is now in advanced testing.
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This new drug is called RLF-100 or aviptadil, and it’s “a synthetic form of a natural peptide that protects the lung,” per Reuters. Aviptadil has been created by two pharmaceutical companies, Swiss Relief Therapeutics and the US-Israeli firm NeuroRx. The two obtained fast-track designation in June in the US, when the Food and Drug Administration (FDA) approved it as COVID-19 therapy.
The drug is a formulation of synthetic human Vasoactive Intestinal Polypeptide (VIP), the two companies explained in mid-June. At the time, they announced the expansion of Phase 2 clinical trials, adding patients from the Houston Methodist Hospital. The drug “inhibits pro-inflammatory cytokines and protects alveolar type-2 cells in the lungs inhibiting pro-inflammatory cytokines.” Those type-2 cells are “essential to oxygen exchange and are preferentially targeted by the SARS-CoV-2 virus,” the June announcement said.
The company is currently conducting a Phase 2/3 trial with 70 patients, but the drug has also been approved for emergency use, and some patients who are too ill to be included in the trial will receive the drug.
Doctors from the Houston Methodist Hospital said that a 54-year-old man who developed COVID-19 while he was treated for rejection of a double lung transplant received the drug. He was taken off a ventilator four days after the treatment began. Similar results were seen in more than 15 patients who were given aviptadil, the companies revealed.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” NeuroRX CEO and Chairman Prof. Jonathan Javitt said in a statement. “We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month.”
All of this is great news, but more research will need to prove the aviptadil drug is both effective and safe for COVID-19 patients. The last thing the world needs is another case of what happened with hydroxychloroquine. If aviptadil is indeed as effective at blocking the virus from replicating in lung cells, then it could end up being the first drug that makes COVID-19 much more manageable.
Tags: Aviptadil, coronavirus, covid-19
It didn't even show up in IHUB until I set it up once I made original investment...that's why the setup is so very BASIC and doesn't have a moderator.
What an exciting day....congrats to you too IBRICH!!
yea....amazing how that happens!
176+ million shares traded so far. Bid/Ask are tight. Buyers are wanting in!
OVER 140,000,000 million shares traded in the past 3 hours. This is insane!!
1.050 million share block on the bid at .056
48 Million shares so far in the first 15 minutes. 90% slant towards buys vrs. sells.
Over 30mm trades in the first 5 minutes of trading.
Agree. We know at this point it can at a minimum push up to .28/.30...it's already done it once. What other stock has Phase 3 FDA green lite, IND submission already in place for Phase 3 and now we have positive news that makes this company, this stock, this COVID option...SOLID beyond our expectations. I don't have enough technical background to really grasp what the obstacles of having 2.5 billion shares will do to impact overall trading, but do have enough experience to know we should be able to make some significant moves upward.
GLTY on both RLFTF and RVVTF. Both GREAT news over the past weekend!
2.5 BILLION shares. Only negative element to this company. I'm curious but haven't looked any further in to it other than the thought as to "why?" we have 2.5 billion shares on open market. Another play of mine somewhat similar RVVTF, Phase 3 Approval granted Friday by FDA only has 189 Million shares. It too is a Canadian stock.
370,000 buys posted already this morning. given that otc/pinks don't trade pre/after market...the mm are going at it strong.
The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.3 The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.
"No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."
The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.
Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.2 clinicaltrials.gov NCT04311697.
NEWS IS OUT - 8/2/20
https://finance.yahoo.com/news/rlf-100-aviptadil-clinical-trial-200000564.html
RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells
PR Newswire PR Newswire•August 2, 2020
- Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites
- Aviptadil is being developed as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes
- RLF-100 is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide VIP), which has been granted FDA Fast Track Designation, FDA emergency use IND authorization, and an expanded access protocol
RADNOR, Pa. and GENEVA, Aug. 2, 2020 /PRNewswire/ -- NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) "Relief" today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.
RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted.
The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.
Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.2 clinicaltrials.gov NCT04311697.
The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.3 The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.
"No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."
About VIP in Lung Injury
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the Alveolar Type II cell, which is critical for the transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. 2 These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Continue reading
Thanks...
huh...that's weird. Pronto means fast,,,,rapido.
shouldn't that be prontomail.com?
What/Who are Robinhood Players?
News is out!
Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19
8:38 AM ET 7/31/20 | Dow Jones
Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19
TORONTO, July 31, 2020 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. ("Revive" or the "Company") (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that the U.S. Food & Drug Administration ("U.S. FDA") has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
"The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally," said Michael Frank, Revive's Chief Executive Officer. "We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner."
About the Phase 3 Confirmatory Clinical Study
The Phase 3 confirmatory clinical study titled, "A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19", will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day ("TID"), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through Day 28 following randomization. Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID--19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board ("DSMB") after 210 patients have been treated and followed up for a total of 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.
Scientific Rationale of Bucillamine for COVID-19
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 increase antioxidant 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 increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive's cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1-888-901-0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Etrade Status
RVVTF REVIVE THERAPEUTICS LTD COM
$0.1775 0.000 (0.00%)
Delayed quote: Jul 31, 2020, 8:06 AM ET
Extended hours
$0.2122 +0.0347 (+19.55%) Bid x Size $0.165 x 15,000 Ask x Size $0.1856 x 10,000
Jul 30, 2020 (Penny Stocks via COMTEX) -- Should Biotech Penny Stocks Be Part Of Your Strategy Right Now?
Volatility is a big part of penny stocks. Then, when you pair it with a volatile sector, it could be the "perfect storm" for that high-risk, high-reward. Small- and micro-cap biotech penny stocks are some of the most volatile and for good reason. It has everything to do with the speculative nature of the companies themselves.
These are typically early-stage companies in pre-clinical stages working to develop novel treatments. Other companies may deal with medical devices too. We saw plenty of medical device penny stocks surge earlier this year with COVID-19 pushing demand for personal protective equipment. There were also companies benefiting from growing demand for coronavirus testing.
Whether it's healthcare settings or virtual settings, there are plenty of angles to play biotech and health care. It even folds in technology in the form of telehealth applications. With coronavirus cases climbing in the U.S., this is likely going to be a clear focus for quite some time.
Read More
Top Penny Stocks To Watch Right Now After Latest News
4 Penny Stocks To Buy For Under $4.50; For Now
In addition, you can't help but to think that many of these companies have other treatments in their pipelines. Investors searching for coronavirus penny stocks at first could also gain exposure to traditional biotech as well. Things like cancer treatments and autoimmune therapies are all things to take into account. With that in mind, let's take a look at a few biotech penny stocks to watch for the upcoming month of August.
Biotech Penny Stocks To Watch: Revive Therapeutics Ltd.
Shares of Revive Therapeutics Ltd. (RVVTF Stock Report) (RVV) has been on a slow rise over the last few months. if you look at the chart, you'll obviously see big spikes, including the recent jump to highs of $0.50. But then if you look at some technical levels, you'll notice that RVVTF stock has followed along with its 50-day moving average since March. That has seen the biotech penny stock climb from around $0.04 at the time to recent trading levels of $0.19. A consistent move of 375% heading into August and after its last big update could be something to note.
At the end of June, Revive announced the submission of an Investigational New Drug application to the U.S. FDA. This was for a Phase 3 confirmatory study for Bucillamine. The trial is to see Bucillamine as a potential treatment in COVID-19. The company has also previously met with Health Canada in a Pre-Clinical Trial Application meeting. Revive also said that it intends to follow up with the submission of the complete CTA package for Health Canada around its Phase 3 study as part of the same multinational clinical strategy.
As far as the first Phase 3 study is concerned, once the U.S. FDA allows the IND to go into effect, Revive said it will initiate a randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 in Q3-2020. With much more attention on coronavirus vaccine stocks, it's not surprising to see this momentum in July. Is August setting up to experience something similar?
You post is past tense "owned" did you sell of your shares? Buy back?
Just watched squawkbox interview with CEO....part of defensive act to keep production in america instead of sending to other countries. That seems to be priority driving factor for $$ dispersed.
We have news!
https://finance.yahoo.com/news/fda-grants-expanded-access-protocol-053000018.html
FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19
Expanded access protocol, including for pregnant women, is becoming available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100,
RLF-100, a patented formulation of Aviptadil, is currently in development by NeuroRx and RELIEF THERAPEUTICS Holding AG under Fast Track Designation, and recently obtained positive safety opinion from the data monitoring committee.
The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839.
Further information may be obtained from expandedaccess@neurorxpharma.com.
Figured....just been a crap day at work so thought I'd release some stress and be a bit combative...no offense intended and none taken.
Excellent Post Alexander!! Thank you!
THIS IS A REALLY EXCITING OPPORTUNITY.
DOES ANYONE HAVE ANY THOUGHTS ON THE PROSPECT OF PEER REVIEWS COMING FORTH?
Agree with MrNormal....nice catch!
Thank you for the DD
Enjoy your weekend.
3BB
https://clinicaltrials.gov/ct2/show/NCT04360096#outcomemeasures
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter Randomized Placebo-controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the study pharmacist will be aware of treatment assignment
Primary Purpose: Treatment
Official Title: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 30, 2020
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Moderate COVID-19 RLF-100
Patients with Moderate COVID-19 to be treated with inhaled RLF-100 (aviptadil) by mesh nebulizer 100µg 3x daily
Drug: RLF-100 (aviptadil)
Inhaled RLF-100 (aviptadil) 100µg 3x daily by mesh nebulizer
Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product
Experimental: Moderate COVID-19 Placebo
Patients with Moderate COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation
Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product
Experimental: Severe COVID-19 RLF-100
Patients with Severe COVID-19 to be treated with inhaled RLF-100 (aviptadil) by mesh nebulizer 100µg 3x daily
Drug: RLF-100 (aviptadil)
Inhaled RLF-100 (aviptadil) 100µg 3x daily by mesh nebulizer
Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product
Experimental: Severe COVID-19 Placebo
Patients with Severe COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation
Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product
Outcome Measures
Go to sections
Primary Outcome Measures :
Progression to ARDS [ Time Frame: 28 days ]
Progression to ARDS is defined as the need for mechanical ventilation
Secondary Outcome Measures :
Blood oxygenation [ Time Frame: 28 days ]
Blood PO2 as measured by pulse oximetry
RDP Dsypnea Scale [ Time Frame: 28 days ]
0 = no shortness of breath at all 0.5 = very, very slight shortness of breath
= very mild shortness of breath
= mild shortness of breath
= moderate shortness of breath or breathing difficulty
= somewhat severe shortness of breath
= strong or hard breathing
7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity
Distance walked in six minutes [ Time Frame: 28 days ]
Distance walked in six minutes
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 12 Years to 85 Years (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Moderate or Severe COVID-19 by FDA definition with no evidence of Respiratory Failure
Capable of using mesh nebulizer to administer medication with assistance if needed
Exclusion Criteria:
Evidence of Respiratory Failure
Use or impending use of ventilation or high flow nasal oxygen 20L or greater
4) Age <12 years; 5) Diastolic pressure < 65 mm Hg; 6) Irreversible underlying condition with projected fatal course; 7) Immunosuppressive treatment for transplant or other reasons; 8) Cancer, renal failure, congestive heart failure, neurological disorder 9) Recent myocardial infarction with Troponin >0.5
Contacts and Locations
Go to sections
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360096
Contacts
Contact: Robert E Besthof, MIM +48425461134 rbesthof@neurorxpharma.com
Sponsors and Collaborators
NeuroRx, Inc.
Investigators
Study Chair: Jonathan C Javitt, MD, MPH NeuroRx
More Information
Go to sections
Additional Information:
Javitt JC: Perspective: The potential role of vasoactive intestinal peptide in treating COVID-19 This link exits the ClinicalTrials.gov site
Pathogenesis of COVID-19 from a cell biologic perspective This link exits the ClinicalTrials.gov site
Responsible Party: NeuroRx, Inc.
ClinicalTrials.gov Identifier: NCT04360096 History of Changes
Other Study ID Numbers: RLF-100_002
First Posted: April 24, 2020 Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NeuroRx, Inc.:
Corona Virus
VIP
Aviptadil
Vasoactive Intestinal Polypeptide
Detailed Description:
Attack of the Alveolar Type II (ATII) cell via its ACE2 surface receptor by the SARS-CoV-2 virus leads to respiratory failure, morbidity, and frequently mortality in COVID-19. There is no approved treatment that specifically targets the pulmonary injury. Vasoactive Intestinal Peptide (VIP) is known to target the VPAC1 receptor of the ATII cell and to protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies. Aviptadil, a synthetic form of Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and Pulmonary Hypertension and EMEA Orphan Drug Designation for the treatment of ARDS and Sarcoid. RLF-100 (Aviptadil) has been granted FDA Fast Track Designation for the treatment of ARDS/Acute Lung Injury in COVID-19.
The objective of this study is to identify patients with moderate and severe COVID-19 who have not yet developed respiratory failure and to treat them with inhaled Vasoactive Intestinal Polypeptide (VIP) in the hope of preventing progression to Critical COVID-19 with Respiratory Failure.
Nonclinical studies demonstrate that VIP is 70% concentrated in the lung, where it binds primarily to ATII cells. VIP prevents NMDA-induced caspase-3 activation in the lung, inhibits IL6 and TNFa production, protects against HCl-induced pulmonary edema, 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.
Both intravenous and inhalation preclinical toxicology and safety pharmacology have been performed in four species, with a six month trial of inhaled RLF-100 in primates.
Aviptadil is approved for human use in Europe and has a demonstrated 20 year history of safety in numerous trials for Sarcoid, Pulmonary Fibrosis, Bronchospasm, Erectile Dysfunction, 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 GCP phase 2 trials of RLF-100 have been conducted under European regulatory authority. Non GCP 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).
In this study, patients patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 100 µg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFa IL-6 and other cytokines.
Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter Randomized Placebo-controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the study pharmacist will be aware of treatment assignment
Primary Purpose: Treatment
Official Title: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 30, 2020
Nice find BRICH....THank you!
Additional link
https://clinicaltrials.gov/ct2/show/NCT04360096