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New COVID-19 Drug Passes Phase 2 Clinical Trial

AHA Publisher — Thu, 20 Jan 2022 08:00:34 +0000

Sanford Burnham Prebys via Newswise – LA JOLLA, CALIF. – Jan 18, 2021 – In a phase 2 clinical trial conducted by Avalo Therapeutics and supported by researchers from Sanford Burnham Prebys, a significantly higher proportion of hospitalized patients with COVID-19 remained alive and free of respiratory failure for 28 days after receiving treatment with a new antibody called CERC-002. Unlike other experimental COVID therapies, CERC-002 does not target the virus itself, instead targeting the immune response associated with the virus to stop the disease from progressing before it becomes fatal. “At the beginning of the pandemic we thought vaccines were going to be all we really needed. But with variants like omicron, we’re going to have more people that progress to serious illness even with the vaccine,” says study coauthor Carl F. Ware, Ph.D., director of the Infectious and Inflammatory Diseases Center at Sanford Burnham Prebys. “We need treatments to stop the progression to severe disease and death.” The findings were published December 6 in the Journal of Clinical Investigation. COVID-19: a Continuing Crisis In the United States, over 800,000 people have died from COVID-19. A large proportion of these deaths have been among the elderly or those who are immunocompromised due to a preexisting condition. And while three quarters of the population has received at least one dose of the COVID-19 vaccine, many remain unvaccinated. “A lot of us feel safer now that we’ve gotten our shots,” Ware says, “but the threat of the pandemic has not gone away, even for vaccinated people.” Most people with COVID-19 experience few to no symptoms. However, elderly individuals, people with a concurrent health condition or those who are immunocompromised are susceptible to a condition called cytokine storm, in which their own immune molecules called cytokines flood the body in higher concentrations than usual. Rather than helping fight the virus, these extra immune molecules wreak havoc, causing patients to develop the deadly respiratory failure characteristic of severe COVID disease. “The COVID virus gets the immune system amped up by producing these molecules, which is normally how the immune system fights diseases,” says Ware. “But when there are too many cytokines and they’re not doing their job, it can lead to severe damage.” Neutralizing the Cytokine Storm The new treatment, CERC-002, is a cytokine neutralizer—an immune molecule that recognizes and deactivates a cytokine known as LIGHT, which is elevated in patients with COVID-19. Cytokine neutralization drugs are currently being tested in the clinic, but they are mainly effective in severely ill patients who are already on a ventilator or other organ support. “There is a critical need for drugs to stop milder cases from progressing to severe,” says Ware. “This treatment targets the cytokine immune response early enough to stop it in its tracks, which no other treatment does right now.” 83 COVID patients were enrolled in the study, half receiving the treatment, and half receiving a placebo. All patients were hospitalized with mild-to-moderate respiratory distress and were also receiving standard-of-care therapy during the trial. They found that 83.9% of patients who received a dose of CERC-002 on top of standard of care remained alive and free from respiratory distress for 28 days. For patients receiving placebo, the number was only 64.5%. Looking Ahead As a phase 2 clinical trial, the purpose of this study was to test whether the compound has therapeutic potential in a small number of patients. Now that the drug has proven successful at a small scale, it can be tested on a larger number of patients to ensure its benefits are consistent across the population. Additionally, because CEC-002 targets the immune response in COVID cases rather than the virus itself, the compound may have applications that extend beyond COVID. “Cytokine storm is not unique to COVID. It occurs in other infections—even in autoimmune diseases with no active infection, so this treatment may have some utility in these other diseases as well.” While there is more work to be done before CERC-002 becomes widely available, it does offer a glimmer of hope during a pandemic that seems never-ending. “We have made a lot of progress in controlling the pandemic with vaccines and other new therapies, but it’s not over yet,” says Ware. “Treatments like this may bring physicians an option to protect infected people from severe illness. To read the original article click here.

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Top Israeli Doctor Says Ivermectin Could Help Treat COVID, Urges More Research

AHA Publisher — Tue, 05 Oct 2021 07:00:32 +0000

Chris Mitchell via CBN News – JERUSALEM, Israel – In the battle against COVID-19, most of the world has turned to vaccines as the main line of defense. Still, a number of doctors and hospitals are looking for other options that could potentially play a role in defeating this global pandemic. Several treatments have seen success in treating the disease, such as Regeneron and Remdesevir. The drug Ivermectin also continues to generate interest. While the FDA and other organizations advise against it, one Israeli doctor is reporting positive results in clinical trials. Professor Eli Schwartz is with the Sheba Medical Center in Israel, considered one of the world’s top hospitals. For decades, Prof. Schwartz has traveled the world fighting outbreaks like Dengue Fever and Ebola. He also began the Travel Medicine and Tropical Disease Institute at Sheba. At the beginning of the pandemic and months before any vaccine, Israel’s Defense Ministry assigned Schwartz to find a medical solution for COVID-19. Professor Eli Schwartz. Photo: CBN News “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.” That meant putting the drug through a clinical trial that lasted ten 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,” Shwartz 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. 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 that … Ivermectin decreased faster the viral load, and also sterilized the culture much better compared to the placebo,” he said. Schwartz explained to CBN News this means Ivermectin killed the virus and his patients were non-infectious. Schwartz says this 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. 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, as you just mentioned, 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 World Health Organization advises “that Ivermectin only be used be used to treat COVID-19 within clinical trials.” The National Institutes of Health says, “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. “It’s something really very odd. I mean, in my career, I published, I think at least 300 papers and chapters, and I never heard the story that they have with Ivermectin. I think that this kind of international campaign, anti-Ivermectin; same that we have anti-vax, anti-vaccine, we have anti-Ivermectin. I don’t understand,” said Schwartz. 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. 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 this 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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Does Eating Healthy Prevent People from Getting, Dying From COVID?

AHA Publisher — Mon, 27 Sep 2021 07:00:35 +0000

Walla! via The Jerusalem Post – We know that a daily diet that includes lots of fruit and vegetables is healthier, but now it seems that it can also help prevent one from being infected with COVID-19. A new study from Boston published in the journal Gut reports that consuming healthy food like produce may lower the risk of contracting the virus, in addition to lowering the severity of symptoms if one is infected. Although doctors have stated that metabolic conditions including obesity and type 2 diabetes can cause severe coronavirus complications, this study is among the first to add nutrition to the equation. Researchers from Massachusetts General Hospital in Boston added that the effect of diet on COVID-19 risk, as well as on the severity of symptoms is particularly strong among those living in weakened socio-economic areas. Previous reports suggest that poor nutrition is a widespread trait among groups disproportionately affected by the epidemic, but data on the link between diet and the risk of getting the virus and then developing severe symptoms is lacking, said study editor Jordi Marino, a doctoral student and instructor at Harvard Medical School, in a press release. The research team analyzed data collected on 592,571 people from the United States and United Kingdom between March and December 2020. Each participant completed a survey of their dietary habits, with study authors scoring people’s “diet quality,” with an emphasis on fruit and vegetable consumption. During the follow-up period, 31,831 participants developed COVID-19. The findings showed that people who had a healthier diet had a 9% lower risk of contracting the virus compared to people who ate a poorer diet. Similarly, the results showed that those who ate healthier were 41% less likely to develop severe symptoms. “These findings have been consistent in a variety of analyses we performed that address other health habits, social welfare factors, and virus transmission rates in the community,” Marino added in the release. Another one of the researchers, Dr. Andrew Chan, explained that while getting vaccinated and wearing a mass indoors and in crowded spaces is paramount the research suggests that eating properly may reduce the risk of contracting COVID-19. The researchers also observed a cumulative link between poor nutrition, increased socioeconomic deprivation and COVID-19 risk. People who live in poor neighborhoods who rely heavily on fast food are much more susceptible to the virus than any of these conditions alone. Models estimate that nearly a third of virus cases would have been avoided if one of these two conditions didn’t exist, explained Dr. Marino. In conclusion, the researchers believe that making healthy, plant-based foods more available and affordable can help advance the end of the epidemic. “Our findings are a call for governments and those who develop protocols to prioritize healthy eating and welfare with influential policies,” Dr. Marino concluded. To read the original article click here.

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Israeli Scientist Says COVID-19 Could Be Treated for Under $1/day

AHA Publisher — Mon, 30 Aug 2021 07:00:00 +0000

Maayan Jaffe-Hoffman viaThe Jerusalem Post– Ivermectin, a drug used to fight parasites in third-world countries, could help reduce the length of infection for people who contract coronavirus for less than a $1 a day, according to recent research by Sheba Medical Centerin Tel Hashomer. Prof. Eli Schwartz, founder of the Center for Travel Medicine and Tropical Disease at Sheba, conducted a randomized, controlled, double-blinded trial from May 15, 2020, through the end of January 2021 to evaluate the effectiveness of ivermectin in reducing viral shedding among nonhospitalized patients with mild to moderate COVID-19. Ivermectin has been approved by the US Food and Drug Administration since 1987. The drug’s discoverers were awarded the 2015 Nobel Prize in medicine for its treatment of onchocerciasis, a disease caused by infection with a parasitic roundworm. Over the years, it has been used for other indications, including scabies and head lice. Moreover, in the last decade, several clinical studies have started to show its antiviral activity against viruses ranging from HIV and the flu to Zika and West Nile. The drug is also extremely economical. A study published in the peer-reviewed American Journal of Therapeutics showed that the cost of ivermectin for other treatments in Bangladesh is around $0.60 to $1.80 for a five-day course. It costs up to $10 a day in Israel, Schwartz said. In Schwartz’s study, some 89 eligible volunteers over the age of 18 who were diagnosed with coronavirus and staying in state-run COVID-19 hotels were divided into two groups: 50% received ivermectin, and 50% received a placebo, according to their weight. They were given the pills for three days in a row, an hour before a meal. The volunteers were tested using a standard nasopharyngeal swab PCR test with the goal of evaluating whether there was a reduction in viral load by the sixth day – the third day after termination of the treatment. They were swabbed every two days. Nearly 72% of volunteers treated with ivermectin tested negative for the virus by day six. In contrast, only 50% of those who received the placebo tested negative. Over the years, it has been used for other indications, including scabies and head lice. Moreover, in the last decade, several clinical studies have started to show its antiviral activity against viruses ranging from HIV and the flu to Zika and West Nile. The drug is also extremely economical. A study published in the peer-reviewed American Journal of Therapeutics showed that the cost of ivermectin for other treatments in Bangladesh is around $0.60 to $1.80 for a five-day course. It costs up to $10 a day in Israel, Schwartz said. In Schwartz’s study, some 89 eligible volunteers over the age of 18 who were diagnosed with coronavirus and staying in state-run COVID-19 hotels were divided into two groups: 50% received ivermectin, and 50% received a placebo, according to their weight. They were given the pills for three days in a row, an hour before a meal. The volunteers were tested using a standard nasopharyngeal swab PCR test with the goal of evaluating whether there was a reduction in viral load by the sixth day – the third day after termination of the treatment. They were swabbed every two days. Nearly 72% of volunteers treated with ivermectin tested negative for the virus by day six. In contrast, only 50% of those who received the placebo tested negative. IN ADDITION, the study looked at culture viability, meaning how infectious the patients were, and found that only 13% of ivermectin patients were infectious after six days, compared with 50% of the placebo group – almost four times as many. “Our study shows first and foremost that ivermectin has antiviral activity,” Schwartz said. “It also shows that there is almost a 100% chance that a person will be noninfectious in four to six days, which could lead to shortening isolation time for these people. This could have a huge economic and social impact.” The study appeared on the MedRxiv health-research sharing site. It has not yet been peer reviewed. Schwartz said other similar studies – though not all of them conducted to the same double-blind and placebo standards as his – also showed a favorable impact of ivermectin treatment. His study did not prove ivermectin was effective as a prophylactic, meaning that it could prevent disease, he cautioned, nor did it show that it reduces the chances of hospitalization. However, other studies have shown such evidence, he added. For example, the study published earlier this year in the American Journal of Therapeutics highlighted that “a review by the Front Line COVID-19 Critical Care Alliance summarized findings from 27 studies on the effects of ivermectin for the prevention and treatment of COVID-19 infection, concluding that ivermectin ‘demonstrates a strong signal of therapeutic efficacy’ against COVID-19.” “Another recent review found that ivermectin reduced deaths by 75%,” the report said. BUT IVERMECTIN is not without controversy, and hence, despite the high levels of coronavirus worldwide, neither the FDA nor the World Health Organization have been willing to approve it for use in the fight against the virus. Prof. Ya’acov Nahmias, a Hebrew University of Jerusalem researcher, has questioned the safety of the drug. “Ivermectin is a chemical therapeutic agent, and it has significant risks associated with it,” he said in a previous interview. “We should be very cautious about using this type of medication to treat a viral disease that the vast majority of the public is going to recover from even without this treatment.” During Schwartz’s study, there was not any signal of significant side effects among ivermectin users. Only five patients were referred to hospitals, with four of them being in the placebo arm. One ivermectin patient went to the hospital complaining of shortness of breath on the day of recruitment. He continued with the ivermectin treatment and was sent back to the hotel a day later in good condition. The FDA said on its website it “received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin.” The “FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans,” it said. “Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an antiviral (a drug for treating viruses). Taking large doses of this drug is dangerous and can cause serious harm.” The World Health Organization has also recommended against using the drug except in clinical trials. IN CONTRAST, Schwartz said he was very disappointed that the WHO did not support any trial to determine whether the drug could be viable. Last month, Oxford University announced a large trial on ivermectin effectiveness. Schwartz said he became interested in exploring ivermectin about a year ago, “when everyone was looking for a new drug” to treat COVID-19, and a lot of effort was being put into evaluating hydroxychloroquine, so he decided to join the effort. “Since ivermectin was on my shelf, since we are using it for tropical diseases, and there were hints it might work, I decided to go for it,” he said. Researchers in other places worldwide began looking into the drug at around the same time. But when they started to see positive results, no one wanted to publish them, Schwartz said. “There is a lot of opposition,” he said. “We tried to publish it, and it was kicked away by three journals. No one even wanted to hear about it. You have to ask how come when the world is suffering.” “This drug will not bring any big economic profits,” and so Big Pharma doesn’t want to deal with it, he said. SOME OF the loudest opposition to ivermectin has come from Merck Co., which manufactured the drug in the 1980s. In a public statement about ivermectin on its website in February, it said: “Company scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety. It is important to note that, to date, our analysis has identified no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and a concerning lack of safety data in the majority of studies.” But Merck has not launched any studies of its own on ivermectin. “You would think Merck would be happy to hear that ivermectin might be helpful to corona patients and try to study it, but they are most loudly declaring the drug should not be used,” Schwartz said. “A billion people took it. They gave it to them. It’s a real shame.” And not moving forward with ivermectin could potentially extend the time it takes for the world to be able to live alongside the virus, he said. “Developing new medications can take years; therefore, identifying existing drugs that can be re-purposed against COVID-19 [and] that already have an established safety profile through decades of use could play a critical role in suppressing or even ending the SARS-CoV-2 pandemic,” wrote the researchers in the American Journal of Therapeutics. “Using re-purposed medications may be especially important because it could take months, possibly years, for much of the world’s population to get vaccinated, particularly among low- to middle-income populations.” To read the original article click here.

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New Antiviral Drug Completely Suppresses SARS-CoV-2 Transmission Within 24 Hours

AHA Publisher — Mon, 07 Dec 2020 08:00:05 +0000

Georgia State University via News-Medical Net – Treatment of SARS-CoV-2 infection with a new antiviral drug, MK-4482/EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours, researchers in the Institute for Biomedical Sciences at Georgia State University have discovered. The group led by Dr. Richard Plemper, Distinguished University Professor at Georgia State, originally discovered that the drug is potent against influenza viruses. This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission. MK-4482/EIDD-2801 could be game-changing.” Dr. Richard Plemper, Distinguished University Professor, Georgia State University Interrupting widespread community transmission of SARS-CoV-2 until mass vaccination is available is paramount to managing COVID-19 and mitigating the catastrophic consequences of the pandemic. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit: inhibit patients’ progress to severe disease, shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation and rapidly silence local outbreaks. “We noted early on that MK-4482/EIDD-2801 has broad-spectrum activity against respiratory RNA viruses and that treating infected animals by mouth with the drug lowers the amount of shed viral particles by several orders of magnitude, dramatically reducing transmission,” said Plemper. “These properties made MK-4482/EIDD/2801 a powerful candidate for pharmacologic control of COVID-19.” In the study published in Nature Microbiology, Plemper’s team repurposed MK-4482/EIDD-2801 against SARS-CoV-2 and used a ferret model to test the effect of the drug on halting virus spread. “We believe ferrets are a relevant transmission model because they readily spread SARS-CoV-2, but mostly do not develop severe disease, which closely resembles SARS-CoV-2 spread in young adults,” said Dr. Robert Cox, a postdoctoral fellow in the Plemper group and a co-lead author of the study. The researchers infected ferrets with SARS-CoV-2 and initiated treatment with MK-4482/EIDD-2801 when the animals started to shed virus from the nose. “When we co-housed those infected and then treated source animals with untreated contact ferrets in the same cage, none of the contacts became infected,” said Josef Wolf, a doctoral student in the Plemper lab and co-lead author of the study. By comparison, all contacts of source ferrets that had received placebo became infected. If these ferret-based data translate to humans, COVID-19 patients treated with the drug could become non-infectious within 24 hours after the beginning of treatment. MK-4482/EIDD-2801 is in advanced phase II/III clinical trials against SARS-CoV-2 infection. To read the original article click here.

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