COVID treatment Archives - Amazing Health Advances

Kansas Sues Pfizer for Misleading the Public About the Risks of its mRNA COVID-19 Vaccines

The AHA! Team — Wed, 02 Oct 2024 08:06:39 +0000

Cassie B. via Natural News – The state of Kansas has filed a consumer protection lawsuit against the pharmaceutical company Pfizer, accusing it of misleading the public when it comes to both the safety and efficacy of its highly controversial mRNA COVID-19 vaccines. According to the suit, Pfizer knew that its vaccine came with significant adverse effects and manipulated its safety trials in order to deceive the public, violating Kansas’s consumer protection laws as well as previous consent judgments. The suit cites a slew of supporting evidence, including scientific and government research, press releases, interviews, and news reports demonstrating Pfizer’s misdeeds. According to the suit, Pfizer knew that its vaccine came with significant adverse effects and manipulated its safety trials For example, they cited a paper from the New England Journal of Medicine and an FDA memo to support the allegation that Pfizer purposely destroyed the control group of a COVID vaccine trial by providing participants with access to the jab. This made it impossible to fairly evaluate the safety of the vaccine by comparing a vaccinated group to one that was not vaccinated, the lawsuit alleges. In addition, they cited two articles from the British Medical Journal indicating that Pfizer delayed the release of vaccine trial data intentionally and only tested healthy patients in its vaccine trials in a marked departure from what is considered protocol. They cited two articles from the British Medical Journal indicating that Pfizer delayed the release of vaccine trial data intentionally To support their allegation that the company purposefully misrepresented the vaccine’s safety, they included press releases from Pfizer and interviews with CEO Albert Bourla in which the vaccine is presented as safe and effective. The lawsuit also refers to a Freedom of Information Act (FOIA) request filed by the watchdog group Public Health and Medical Professionals for Transparency in America with the FDA, through which they obtained information about the vaccine. From this FOIA suit, the group acquired an internal Pfizer database listing adverse events that was never shared with the public and contained far more incidents than those listed in the public-facing Vaccine Adverse Event Reporting System. In total, the internal database showed nearly 160,000 adverse events, along with more than 1,200 fatalities among the millions of people who received the vaccine as of February 2021. Heart problems and pregnancy complications weren’t disclosed to public The lawsuit also focused on specific health issues that have been coming to light since the vaccine rollout, such as heart problems. Not long after the vaccine started being administered to young people, it became apparent that it was having an adverse effect on their hearts, particularly young men. Myocarditis, which occurs when the middle layer of the heart’s wall becomes inflamed, can weaken the organ and has the potential to cause heart failure. The lawsuit alleges: “Pfizer said its COVID-19 vaccine was safe even though it knew its COVID-19 vaccine was connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths. Pfizer concealed this critical safety information from the public.” Another point of concern cited by the lawsuit is the dangers of the vaccine in pregnant women. It maintains that the company knew from a study that rat fetuses had trouble getting pregnant and implanting embryos and that their fetuses suffered malformations yet insisted to the public that the jab did not present any risk to pregnant women. The rat study was another revelation from the FOIA lawsuit, but the Kansas lawsuit also notes that Pfizer’s own data showed that tens of thousands of women experienced menstrual irregularities after getting the jab as of spring 2022. Kansas attorney general Kris Kobach told the National Review in an interview that the state’s Consumer Protection Act is designed to prevent consumers from being deceived by companies like Pfizer. “They had extraordinary success marketing their vaccine in the state of Kansas and more generally across the globe, and I think that had consumers had this information, many of them might have made a different choice,” he asserted. Sources for this article include: ArmageddonProse.Substack.com NationalReview.com To read the original article, click here: https://www.naturalnews.com/2024-09-20-kansas-sues-pfizer-misleading-public-risks-vaccines.html

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New Study Validates Benefits of Convalescent Plasma for Some COVID-19 Patients

AHA Publisher — Wed, 26 Jan 2022 08:00:26 +0000

NYU Langone Health via Newswise – Transfusions of blood plasma donated by people who have already recovered from infection with the pandemic virus may help other patients hospitalized with COVID-19, a new international study shows. The treatment, known as convalescent plasma, is still considered experimental by the U.S. Food and Drug Administration (FDA). Plasma contains antibodies, blood proteins that are part of the immune system. Shaped so they can attach to the virus that causes COVID-19, SARS-CoV-2, antibodies glom onto and tag it for removal from the body, researchers say. Led by researchers at NYU Grossman School of Medicine, the study showed that among 2,341 men and women, those who received an injection of convalescent plasma soon after hospitalization were 15% less likely to die within a month from COVID-19 than those who did not receive convalescent plasma or those who received an inactive saline placebo. Notably, the researchers found that the biggest benefits for the therapy were among patients most at risk for severe complications because of pre-existing conditions, such as diabetes or heart disease. The treatment, which contains antibodies and other immune cells needed to fight the infection, also appears to benefit those with type A or AB blood. “Our results show that, overall, patients hospitalized with COVID-19 may derive modest benefit from convalescent plasma, with some patient subgroups benefiting more than others,” says study lead investigator and biostatistician Andrea Troxel, ScD. With respect to the groups most likely to benefit, the FDA on Dec. 28, 2021, revised the Emergency Use Authorization for convalescent plasma, limiting its use to patients with diseases that suppress their immune systems, or that receive medical treatments with the same effect. “Patients with co-existing disease were most likely to show improvement from convalescent plasma, probably because they have the most difficulty producing antibodies to fight their infection,” adds Troxel. “The infused plasma boosts their body’s ability to fight the virus, but only in the early stage of the disease and before the illness overwhelms their body.” The current study findings, published in the journal JAMA Network Open online Jan. 25, come from the pooling of patient information from eight recently completed studies in the United States, Belgium, Brazil, India, the Netherlands, and Spain on the effects of convalescent plasma for COVID-19. These benefits of the treatment are only likely to become clear as more data from the trials become available, says Troxel, a professor in the Department of Population Health at NYU Langone. This is because the data from individual trials are too small to show the treatment’s overall impact on subsets of patients, she says. Some individual studies have showed the therapy to be ineffective or of limited value. Study co-investigator Eva Petkova, PhD, says the team is using its study data to create a scoring system of patient descriptors, including age, stage of COVID-19, and co-existing diseases, making it easier for clinicians to calculate who stands to benefit most from use of convalescent plasma. “Our treatment benefit index is designed to serve as a quick and effective tool for physicians to use in deciding when to administer convalescent plasma for COVID-19,” says Petkova, a professor in the Departments of Population Health and Child and Adolescent Psychiatry at NYU Langone. The index is freely available online at [http://covid-convalescentplasma-tbi-calc.org]. For the study, researchers grouped all patient information from smaller, separate clinical investigations about convalescent plasma therapy, including trials at NYU Langone, Albert Einstein College of Medicine and Montefiore Medical Center, Zuckerberg San Francisco General Hospital, and the University of Pennsylvania in Philadelphia. Researchers hoped any benefits or disadvantages in treatment would be easier to spot among the largest possible sample of patients. All trials were randomized and controlled, meaning that the patient had a random chance of being assigned to receive convalescent plasma or not to receive it. Included in the analysis were data from another multicenter U.S. study published separately in December 2021 in JAMA Internal Medicine. That study in 941 patients hospitalized with COVID-19 showed that patients receiving high doses of convalescent plasma therapy and not on other medications, such as remdesivir or corticosteroids, were likely to benefit from the blood plasma treatment. Study co-primary investigator Mila Ortigoza, MD, PhD, an assistant professor in the Departments of Medicine and Microbiology at NYU Langone, says these initial results supported the idea that convalescent plasma could be a feasible treatment option, especially when other therapies are not yet available, as at the beginning of a pandemic. In addition, convalescent plasma collected from previously infected and subsequently vaccinated donors (VaxPlasma) would contain antibodies in high enough quantities and diversity that could provide added protection against emerging viral variants, says Ortigoza. Viruses typically mutate genetically (acquire random changes in their DNA or RNA codes) over the course of any pandemic. For this reason, convalescent plasma has the potential to offer effective treatment more quickly after such mutations than treatment types that tend to become less effective with time and must undergo a re-design process to address a new variant, such as monoclonal antibody treatments. To read the original article click here.

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Pfizer said Antiviral Pill is 89% Among High-Risk Adults

AHA Publisher — Thu, 16 Dec 2021 08:00:54 +0000

WASHINGTON (AP) via CBN News — Pfizer said Tuesday that its experimental pill to treat COVID-19 appears effective against the omicron variant. The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms. Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself. The updates come as COVID-19 cases, deaths and hospitalization are all rising again and the U.S. topped 800,000 pandemic deaths. The latest surge, driven by the delta variant, is accelerating due to colder weather and more indoor gatherings, even as health officials brace for the impact of the emerging omicron mutant. The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pick up at a pharmacy and take at home. President Joe Biden called Pfizer’s drug “another potentially powerful tool in our fight against the virus,” in a statement Tuesday. The U.S. government has agreed to purchase enough of Pfizer’s drug to treat 10 million people. But company executives have indicated that initial supplies will be limited, with only enough to treat tens of thousands of people before the end of the year. By March Pfizer hopes to ramp up production to provide millions of courses of treatment. Pfizer’s data could help reassure regulators of its drug’s effectiveness after Merck disclosed smaller-than-expected benefits for its drug in final testing. Late last month, Merck said that its pill reduced hospitalizations and deaths by 30% in high-risk adults. Both companies initially studied their drugs in unvaccinated adults who face the gravest risks from COVID-19, due to older age or health problems, such as asthma or obesity. Pfizer is also studying its pill in lower-risk adults — including a subset who are vaccinated — but reported mixed data for that group on Tuesday. In interim results, Pfizer said its drug failed to meet its main study goal: sustained relief from COVID-19 for four days during or after treatment, as reported by patients. But the drug did achieve a second goal by reducing hospitalizations by about 70% among that group, which included otherwise healthy unvaccinated adults and vaccinated adults with one or more health issues. Less than 1% of patients who got the drug were hospitalized, compared with 2.4% of patients who got a dummy pill. An independent board of medical experts reviewed the data and recommended Pfizer continue the study to get the full results before proceeding further with regulators. Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo. The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases. Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations. Centers for Disease Control and Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday, said the best way for people to protect themselves against COVID-19 is to get vaccinated and get a booster shot. She said the Pfizer pill if authorized by the FDA, “will be another great tool, but we need to diagnose people early.” To read the original article click here.

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Nebraska AG Allows Ivermectin and HCQ Prescriptions as Off-Label Medicines to Fight COVID

AHA Publisher — Wed, 20 Oct 2021 07:00:31 +0000

Steve Warren via CBN News – Nebraska’s attorney general has said he will not discipline or prosecute physicians who prescribe controversial, off-label drugs in order to treat and prevent COVID-19 infections if they have patient consent. KETV reported Attorney General Doug Peterson issued his 48-page opinion Friday after receiving a question from Nebraska Department of Health and Human Services CEO Dannette Smith. She asked if doctors could face discipline or legal action under Nebraska’s Uniform Credential Act (UCA) if they prescribed medications like Ivermectin and Hydroxychloroquine to fight COVID-19 in their patients. “After receiving your question and conducting our investigation, we have found significant controversy and suspect information about potential COVID-19 treatment,” Peterson wrote. He also cited numerous medical journals’ articles and case studies. “We emphasize… our office is not recommending any specific treatments for COVID-19. That is not our role,” the attorney general continued. “Rather, we address only the off-label early treatment options discussed in this opinion and conclude that the available evidence suggests they might work for some people,” Peterson wrote. “Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained health care system.” The FDA has cautioned against using hydroxychloroquine (HCQ) to treat COVID. Former President Trump took HCQ early in the pandemic to prevent a COVID-19 infection, then he stopped using it in May of 2020. Other famous people said the drug worked for them. Actor Tom Hanks and his wife Rita Wilson said HCQ was useful in their recovery from the coronavirus. Actor Daniel Dae Kim (Lost & Hawaii Five-0) claimed HCQ was the “secret weapon” that helped in his recovery from the disease. Last year, Pastor A.R. Bernard of the Christian Cultural Center in Brooklyn, NY, talked about his harrowing bout with COVID-19 and how the drug cocktail with hydroxychloroquine and the antibiotic azithromycin saved his life. Families Filing Lawsuits Against Hospitals, Seeking Alternative COVID Treatments for Loved Ones At least two dozen lawsuits have been filed around the U.S., many in recent weeks, by people seeking to force hospitals to give their COVID-stricken loved ones ivermectin, a drug for parasites that has been promoted as a treatment despite a lack of conclusive evidence that it helps people with the virus. Interest in the drug started rising toward the end of last year and the beginning of this one, when studies – some later withdrawn, in other countries – seemed to suggest ivermectin had some potential in the fight against COVID-19. But some medical experts suggest having a court step in is not the way to practice medicine. “The way medicine works is, they are the experts, the doctors and… the hospitals,” Arthur Caplan, professor of bioethics at New York University’s Grossman School of Medicine told the Associated Press. “When you go there, you’re not going to a restaurant. You don’t order your own treatments.” “You can’t have a medical field that’s subjected to having to practice according to patient demand backed up by court orders. That is positively horrible medicine,” Caplan said. Ralph Lorigo doesn’t see it that way. The attorney from Buffalo, New York, filed his first of several ivermectin lawsuits in January after being approached by the family of an 80-year-old woman who was in the hospital on a ventilator. His second case was later that month, for a hospitalized 65-year-old woman. In both cases, judges ordered hospitals to allow the women to take ivermectin as their families wanted. Both women survived their hospitalizations, according to the AP. Lorigo, who has taken on numerous cases since is adamant that ivermectin works. Health experts and federal agencies say that any evidence of it being effective against COVID-19 is slim and more research needs to be done. Studies are currently underway. Israeli Clinical Trials Show Positive Results with Ivermectin As CBN News reported earlier this month, a top Israeli doctor was asked by Israel’s government to research treatments for COVID. His studies indicated positive results with ivermectin in clinical trials. Dr. Eli Schwartz, M.D. is the founder of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center in Israel. It’s considered one of the world’s top hospitals. Dr. Schwartz is also a professor at Sackler Faculty of Medicine, Tel Aviv University. For decades, Schwartz has traveled the world fighting outbreaks like Dengue Fever and Ebola. At the beginning of the pandemic and months before any vaccine was available, Israel’s Defense Ministry assigned Schwartz to find a medical solution for COVID-19. “Since Ivermectin is one of the drugs that we are using in daily life in the Tropical Institute, I knew it. I know the safety profile of it. And since there was some hints of in-vitro studies, which show the efficacy against specifically, even against COVID-19, we decided to go for it,” he said. That meant putting the drug through a clinical trial that lasted 10 months. “Our study, which was done here, it’s a randomized controlled trial, double-blind. It’s really, I would say, this is the best method that you are doing studies. And our conclusion is that it really has antiviral activities,” Schwartz told CBN News. From his international experience in the field, Schwartz knew Ivermectin targeted parasites. Since its development in 1987, nearly 4 billion doses with few side effects and at low cost have protected millions of people from insidious parasitical diseases like River Blindness and Elephantiasis. That success won its developers the Nobel Prize for medicine in 2015. Schwartz’s study made headlines in Israel when his trial showed Ivermectin to also be anti-viral. “This is the first drug to show antiviral activity,” the doctor explained. “And then, I think, there’s a good reason to continue with a much more thorough investigation to see, for example, whether people who are at high risk, may not deteriorate to be hospitalized, to be mechanically ventilated, or to death.” Schwartz’s clinical study found that by day four, 86% of his patients who took ivermectin recovered. By day six, 94% recovered. “The bottom line is… Ivermectin decreased faster the viral load, and also sterilized the culture much better compared to the placebo,” he noted. Schwartz explained to CBN News this means Ivermectin killed the virus and his patients became non-infectious. He said this development could save lives and reduce quarantines by days. “It’s a huge change in life. It’s a huge change for the patient. It’s a huge change for his family. And from the economical point of view, it’s a dramatic change. You know, it’s how much money you can save for the economy of the country if you can shorten the isolation time,” he said. Use Not Accepted by Global Heath Professionals But ivermectin is not accepted by the global health establishment. A major FDA concern is that a number of people have tried to self-medicate using a form of the drug intended for livestock. “Don’t do it. There’s no evidence whatsoever that it works and it could potentially have toxicity…with people who have gone to poison control centers because they’ve taken the drug at a ridiculous dose and wind up getting sick,” said Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. The World Health Organization advises “that Ivermectin only be used be used to treat COVID-19 within clinical trials.” The National Institutes of Health said, “Ivermectin is not approved by the FDA for the treatment of any viral infection” and that “well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.” For studies to be accepted by the broader medical community, it must be peer-reviewed and published in a medical journal. That’s where Prof. Schwartz hit a roadblock. Several journals turned him down, but one is currently reviewing his study. Schwartz added that while many health agencies want better studies, no large-scale trials on ivermectin happened until Oxford University began one in June of this year. “I mean, it took them 18 months from the beginning of the pandemic to try to do it. I mean, people dying all over the world. And you have drug under your hand and you have to wait so long until you get any conduction of a good study,” he said. ‘We Are in the Arms of Pharma, and the Pharma Is Looking for New Drugs’ Now, the pharmaceutical company Merck, which developed ivermectin, and Pfizer are in a race to produce an oral anti-viral drug for COVID that some believe is what ivermectin could do already. “In my view, the whole story of Ivermectin is much beyond Ivermectin. It’s even beyond the corona. The problem is that we are in the arms of the pharma and the pharma is looking for new drugs. And, therefore, all old drugs which might be with a good potential to use it for whatever you’re looking for, there’s not any parents to push for it,” Schwartz claimed. Prof. Schwartz advocates the use of ivermectin but also believes in the vaccine. “Most of the world, still vaccine is not available. So, if we have a medication that can try to reduce the magnitude of the pandemic in the meantime, that’s absolutely needed, but when, if I have to compare the vaccine and Ivermectin for prevention, no doubt the vaccine. This is the solution, the international solution,” he said. Schwartz hopes more research will prove the drug can help fight the pandemic and that it will eventually be allowed to treat patients on a widespread basis and not just within clinical trials. To read the original article click here.

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The Dream Team: Scientists Find Drug Duo That May Cure COVID-19 Together

AHA Publisher — Wed, 09 Jun 2021 07:00:11 +0000

Tokyo University of Science via EurekAlert – COVID-19 continues to claim lives across the world and is infecting millions more. Although several vaccines have recently become available, making significant strides towards preventing COVID-19, what about the treatment of those who already have the infection? Vaccines aren’t 100% effective, highlighting the need–now more than ever–for effective antiviral therapeutics. Moreover, some people can’t receive vaccines due to health issues, and new variants of SARS-CoV-2, the virus that causes COVID-19, that can penetrate vaccine-conferred immunity, are being reported, indicating that we need to think beyond prevention. Given this need, a team of researchers based in Japan, the US, and the UK launched a project to develop effective therapeutics. This team included several researchers based at Tokyo University of Science: Visiting Professor Koichi Watashi, Dr. Hirofumi Ohashi, Professor Shin Aoki, Professor Kouji Kuramochi, and Assistant Professor Tomohiro Tanaka. Their goal was clear and simple: finding a cure for COVID-19. To achieve this goal, the researchers first established an experimental system for screening drugs that may help to control infections. This system used a type of cells called VeroE6/TMPRSS2 cells, which were manipulated to efficiently be infected with and produce SARS-CoV-2. “To determine whether a drug of interest could help combat infection by SARS-CoV-2, we simply had to expose VeroE6/TMPRSS2 cells to both the drug and SARS-CoV-2 and then observe whether the drug’s presence served to hinder the virus’s efforts to infect cells,” explains Professor Watashi. The researchers used this experimental system to screen a panel of drugs that are already approved for clinical use, including drugs like remdesivir and chloroquine that have already being approved or are being trialed as treatments for COVID-19. In an exciting outcome, the researchers found two drugs that provided effective SARS-CoV-2 suppression: cepharanthine, which is used to treat inflammation, and nelfinavir, which is approved for the treatment of HIV infection. Cepharanthine inhibited the entry of the virus into cells by preventing the virus from binding to a protein on the cell membrane, which it uses as a gateway. In contrast, nelfinavir worked to prevent the virus from replicating inside the cell by inhibiting a protein that the virus relies on for replication. Given that these drugs have distinct antiviral mechanisms, using both of them together could be especially effective for patients, with computational models predicting that combined cepharanthine/nelfinavir therapy can hasten the clearance of SARS-CoV-2 from a patient’s lungs by as few as 4.9 days. So, does this mean we will be seeing these new drugs in COVID-19 treatment centers? Of course, the drug duo isn’t ready to be rolled out into healthcare systems just yet. These findings justify further research into the clinical potential of cepharanthine/nelfinavir therapy, and only following this can we say for sure that it is useful and helpful. Nevertheless, given the ongoing nature of the COVID-19 pandemic and the ever-increasing death toll, the development of cepharanthine/nelfinavir therapy may provide clinicians and patients with a much-needed new treatment option. To read the original article click here.

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Has Israel Just Found the Cure for Covid?

AHA Publisher — Tue, 09 Feb 2021 08:00:39 +0000

Abigail Klein Leichman via Israel21c – Even with Israel’s world-leading rollout of Covid-19 vaccinations, drugs to treat Covid patients are in desperate need across the world. Two such drugs developed in Israel show great promise in clinical trials: EXO-CD24 and Allocetra. EXO-CD24, an experimental inhaled medication developed at Tel Aviv Sourasky Medical Center, cured all 30 moderate-to-severe cases in a Phase I clinical trial. Developed over the past six months at the hospital, EXOCD24 stops the “cytokine storm” – where the immune system goes out of control and starts attacking healthy cells – that occurs in the lungs of 5-7% of Covid-19 patients. “To date, the preparation has been tried with great success on 30 severe patients, in 29 of whom the medical condition improved within two to three days and most of them were discharged home within three to five days. The 30th patient also recovered but after a longer time,” the hospital reports. “The drug is based on exosomes, [vesicles] that are released from the cell membrane and used for intercellular communication. We enrich the exosomes with 24CD protein. This protein is expressed on the surface of the cell and has a known and important role in regulating the immune system,” explained Dr. Shiran Shapira, director of the laboratory of Prof. Nadir Arber, who has been researching the CD24 protein for over two decades. “The preparation is given by inhalation, once a day, for only a few minutes, for five days,” Shapira said. She said the experimental treatment has two unique characteristics. The first is that it inhibits the over-secretion of cytokines. The second is that it is delivered directly to the lungs and therefore has no systemic side effects that injected or oral drugs can cause. “Even if the vaccines perform their function, and even if no new mutations are produced then still in one way or another the corona will remain with us,” said Arber, director of the medical center’s Integrated Cancer Prevention Center. “To this end, we have developed a unique drug, EXO-CD24.” Arber added that this advanced preparation “can be produced quickly and efficiently and at a very low cost in every pharmaceutical facility in the country, and in a short time globally.” Prof. Ronni Gamzu, CEO of the medical center, said, “Prof. Arber’s results for first-phase research were excellent and gave us all confidence in the method he has been researching [here] for many years. I personally assisted him in further obtaining the approvals from the Ministry of Health for further research.” Allocetra Meanwhile, Enlivex Therapeutics last week reported positive results from a multi-center Phase II clinical trial of its experimental Covid-19 immunotherapy drug Allocetra in severe and critical Covid-19 patients. We reported in October that five Covid-19 intensive care patients were discharged from Hadassah University Medical Center in Jerusalem after treatment with Allocetra. Nine severe and seven critical Covid-19 patients were treated with Allocetra in the Phase II clinical trial. Fourteen of them recovered and were discharged from the hospital after an average of 5.3 days. The Phase II trial originally was expected to enroll 24 patients but was “completed early in support of anticipated accelerated regulatory filings of the trial’s positive safety and efficacy data,” Enlivex reported. Altogether, 19 out of 21 Phase II and Phase Ib Allocetra trial patients recovered and were discharged from the hospital after an average of 5.6 days. Most of the patients in both studies had pre-existing risk factors such as male gender, obesity and hypertension. “The results we have seen from the 12 Covid-19 patients treated to date with Allocetra are exciting,” said Prof. Vernon van Heerden, head of the General Intensive Care Unit at Hadassah and the lead investigator of both clinical trials. “The Phase II patients who have been discharged from the hospital are currently healthy. We believe that these compelling results have demonstrated the safety and efficacy of Allocetra in these complicated patients, highlighting the potential of Enlivex’s product candidate to benefit severe and critical Covid-19 patients as well as others suffering from cytokine storms and organ dysfunctions across various clinical indications.” Allocetra is based on the research of Enlivex chief scientific and medical officer Dr. Dror Mevorach, head of internal medicine and of one of Hadassah’s coronavirus wards. It works by restoring balance to the immune system. Mevorach said Allocetra “may have utility as a safe and efficacious treatment … regardless of the specific coronavirus mutation that afflicted the patients, and across different life-threatening, high mortality clinical indications with high unmet medical needs.” To read the original article click here. For more articles from Israel21c click here.

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Does Blood Plasma from COVID-19 Survivors Help Patients Infected with Novel Coronavirus?

AHA Publisher — Sat, 11 Jul 2020 07:00:30 +0000

University of California San Diego Health via Newswise – A new clinical trial at UC San Diego Health will investigate whether an old therapy might effectively treat a modern-day scourge. There is only one approved, specific treatment for COVID-19, the illness caused by the novel coronavirus SARS-CoV-2, albeit with modest efficacy. Numerous experimental or repurposed drugs are under investigation, including the arthritis drug tocilizumab. And one treatment that is more than a century old. Researchers at University of California San Diego School of Medicine and UC San Diego Health have launched a clinical trial to assess the safety and efficacy of convalescent plasma (CP) to prevent COVID-19 after a known exposure to the virus. CP therapy involves infusing patients with antibodies extracted from the blood of donors who have successfully recovered from COVID-19, with the hope that the resulting boost to their immune systems will shorten the length and reduce the severity of the disease. The UC San Diego trial is part of a larger, national effort approved by the U.S. Food and Drug Administration. The goal is to create a network of hospitals and blood banks collecting, isolating, processing and testing whether plasma from COVID-19 survivors has therapeutic, preventive value. The national trial is being coordinated by Johns Hopkins University and sponsored by the National Insitute of Health through the Department of Defense. “With convalescent plasma therapy, we want to act prophylactically, using a product with known high-titers (concentrations) of neutralizing antibodies,” said Edward Cachay, MD, an infectious disease specialist at UC San Diego Health and professor of medicine at UC San Diego School of Medicine. “We want to learn how we can prevent sickness, how we can prevent COVID patients from needed mechanical ventilation, and how we can prevent them from dying from the disease.” Before the emergence of antibiotics, CP was used to prevent and treat a host of bacterial and viral infections, including diphtheria, scarlet fever and pertussis. It was used during the 1918 influenza pandemic with reported good effect. In general, CP treatment has proven safe, but its effectiveness has varied with disease and among individuals. Studies of CP therapies for Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and the 2009 H1N1 influenza showed measurable reductions of mortality (compared to placebo or no therapy), but efforts to treat Ebola virus infections during the 2014-16 outbreak in West Africa were inconclusive. Chinese researchers treating COVID-19 patients have reported some success using CP, albeit not in randomized, controlled studies — the gold standard in clinical research. On April 13, the Food and Drug Administration (FDA) issued research guidelines for assessing CP as a potential COVID-19 treatment and the American Red Cross is currently seeking blood plasma donors who have fully recovered from novel coronavirus infections. Plasma is the liquid portion of blood that carries blood components throughout the body, such as red and white blood cells, platelets, salts and enzymes. It also contains proteins and antibodies produced by the body’s immune system to fend off invasive pathogens, such as SARS-CoV-2. To qualify as a plasma donor for COVID-19 patients, donors must be at least 17 years old and weigh 110 pounds; be in good health; and have a prior, verified diagnosis of COVID-19 but are now symptom-free and fully recovered. The UC San Diego Health clinical trial will recruit a total of 487 qualifying participants for the study. Criteria to qualify for participation include a high-risk factor, such as age or an underlying condition, like cardiovascular disease, diabetes, existing pulmonary impairment or employment as a health care worker; known exposure to SARS-CoV-2; and a negative PCR diagnostic test to show no current infection. Testing will be conducted inside tents set up across from the emergency department at Jacobs Medical Center and the Altman Clinical and Translational Research Institute (ACTRI) on the La Jolla health campus. The UC Health Blood Bank is coordinating efforts with the San Diego Blood Bank. The ACTRI is providing personnel, infrastructure support and other resources for the CP trial and for other COVID-19-related clinical trials at UC San Diego. In addition, the ACTRI has created a COVID-19 Biobank to provide materials for research projects to diagnose or treat the disease. In cases of infection by the novel coronavirus, it appears the human immune system begins producing antibodies to the disease five to 10 days after the initial infection. The antibodies bind to the targeted coronavirus, stopping it from latching onto new cells and beginning the production of more viral particles. Over the course of two or so weeks, the body clears out the virus, but antibodies to it (or the blueprints for making them) remain. The depth and length of subsequent immunity have not been determined. Cachay said he thinks CP will likely be most effective in persons with early exposure to the novel coronavirus, before symptoms appear, but it will require a clinical trial to substantiate that thinking. “If we don’t do this, if we just gather anecdotal evidence that isn’t conclusive, then we won’t be any better off when the next wave hits.” To read the original article click here.

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