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Medicine That Treats Gout Could Also Battle COVID-19

AHA Publisher — Mon, 13 Sep 2021 07:00:43 +0000

University of Georgia via Newswise – As COVID-19 cases continue to skyrocket across the U.S. and the world, few options are available for treating patients infected with the SARS-CoV-2. But new research from the University of Georgia offers hope for a viable therapeutic to combat the disease that has claimed more than 4 million lives worldwide. Published in Nature’s Scientific Reports, the study found that probenecid has broad antiviral properties, making it a prime candidate to combat not only SARS-CoV-2 infection but also other common and deadly respiratory viruses like RSV and flu. Probenecid is an FDA-approved medication that’s primarily used to treat gout, and it’s already widely available in the U.S. The drug has been on the market for over 40 years and has minimal side effects. “There’s really nothing out there to safely fight these viruses,” said Ralph Tripp, lead author of the study and GRA Eminent Scholar of Vaccine and Therapeutic Studies in UGA’s College of Veterinary Medicine. “This antiviral works for all RNA respiratory viruses we tested, including SARS-CoV-2. RSV, coronavirus and flu all circulate in the same season. Bottom line is you can potentially reduce infection and disease using this one oral drug.” Blocking Viral Reproduction Viruses work by coopting a person’s own cells to replicate and produce more of the virus. Probenecid blocks that replication process, keeping the virus from infecting the individual’s cells. In clinical development at the pharmaceutical company TrippBio, Tripp showed the drug works as a prophylactic prior to virus exposure and as a post-exposure treatment in animal models against SARS-CoV-2 and flu. The drug also has proven effective in fighting the RSV in vitro, and in vivo studies are in progress. Although the drug would primarily be used after a person is positive for the virus, the prophylactic findings mean people with known exposures could also potentially take the drug to prevent getting sick. COVID-19 Treatment Options Limited The current go-to treatments for seriously ill COVID-19 patients, remdesivir and monoclonal antibodies, can only be given through an IV. And by the time a COVID patient needs them, it’s often too late. “These treatments have seen some effectiveness against SARS-CoV-2, but they’re very expensive and very hard to come by,” Tripp said. “In reality, there are only a handful of options that can actually be used because of the cost, restricted IV usage, and lack of access. That’s not very useful to the world.” Probenecid, on the other hand, is widely available. Primary care physicians could prescribe a pill to patients, and they could pick it up at their local drugstore. Repurposing drugs that are already approved to work against one problem is common. For example, remdesivir was originally intended to fight Ebola virus… In addition to preventing illness before it starts, probenecid may also potentially increase the efficacy of other treatments. Probenecid is already used to up the potency of some antibiotics, so it’s possible the medication could work in conjunction with other COVID-19 treatments as well. Now the researchers are investigating what dosage of probenecid could have the biggest impact fighting viruses in people. TrippBio is set to begin clinical trials of the medication within the year. “SARS-CoV-2, RSV and flu have a huge impact on health systems throughout the world,” Tripp said. “Probenecid has a potent antiviral effect against these viruses, and it works safely.” This article has been modified. 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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Antifungal and Antidepressant Drugs Can Effectively Inhibit COVID-19 Virus

AHA Publisher — Wed, 21 Apr 2021 07:00:39 +0000

Wiley via News-Medical – New research published in the British Journal of Pharmacology indicates that two currently available medications–an antifungal drug and an antidepressant–can effectively inhibit the virus that causes COVID-19 in laboratory cells. Investigators found that the antifungal itraconazole and the antidepressant fluoxetine each blocked the production of infectious SARS-CoV-2 virus in cell culture lab tests. When either drug was used in combination with the antiviral drug remdesiver, the combination showed synergistic effects and inhibited the production of SARS-CoV-2 by more than 90%. “Preventive vaccination and therapeutic medicines against COVID-19 are both required to effectively combat pandemics caused by emerging zoonotic viruses such as SARS-CoV-2.” (Ursula Rescher, PhD, Study Senior Author, University of Muenster, Germany) To read the original article click here.

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Study Suggests Healing Properties of Honey and Nigella Sativa Expedites Viral Clearance in COVID-19 Patients

AHA Publisher — Thu, 12 Nov 2020 08:00:01 +0000

Susha Cheriyedath, M.Sc. via News-Medical Net – The coronavirus disease 2019 (COVID-19) pandemic has impacted over 50 million people so far and has claimed more than 1.25 million lives globally. As the virus continues to spread, with many countries experiencing second waves right now, we still do not have an effective vaccine against COVID-19. This makes finding an effective drug to treat the disease very important, and scientists worldwide are racing against time to find therapeutic solutions that will help treat COVID-19 patients. An ideal treatment would speed up symptomatic recovery, decrease viral load, and expedite viral clearance and reduce mortality. Although certain treatments such as hydroxychloroquine, azithromycin, dexamethasone, remdesivir, antibody therapies, and convalescent plasma have shown some efficacy, an effective treatment to fight severe COVID-19 is still not a reality. Keeping this in mind, a team of researchers from various institutes across Pakistan, Chile, Canada, and the USA recently conducted a clinical trial to investigate the potential effectiveness of a combination of honey and Nigella sativa (HNS) in treating COVID-19 patients. Their study is published on the preprint server medRxiv* prior to the scientific peer review process*. Since previous studies show that both components of HNS have proven anti-microbial, anti-viral, anti-inflammatory, and immune-modulatory effects, the researchers wanted to assess the efficacy of HNS in fighting COVID-19. Healing Properties of Honey and Nigella Sativa Honey has been reported to have beneficial effects against many viruses, including herpes simplex virus (HSV), rubella virus, Hepatitis virus, and Varicella Zoster virus. It is also effective against many multidrug-resistant bacterial strains, especially when used along with antibiotics. In addition to its immunity-boosting effects that stimulate innate as well as adaptive immune responses, honey has been shown to be beneficial in fighting upper respiratory tract infections. Nigella sativa is a medicinal plant commonly known as Black Cumin and has been proven to have anti-viral properties against many viruses, including mouse cytomegalovirus and HCV. In vitro studies have shown that it can decrease the replication of severe acute respiratory syndrome coronavirus (SARS-CoV). Some of its components have a high affinity to many SARS-CoV-2 proteins and enzymes. A Randomized, Controlled Trial to Study the Action of HNS Against COVID-19 The researchers performed a multicenter, randomized, controlled trial in patients with COVID-19 of varying severity. Randomized patients received either a combination of 1 gm/kg/day of honey and 80 mg/kg/day of Nigella sativa or placebo for 13 days. Viral clearance, symptoms, alleviation, and 30-day mortality were some of the outcomes. “The trial results show that the use of HNS in COVID-19 patients promotes viral clearance and reduces the severity of the disease.” Of the 313 patients, part of the study cohort, 210 patients with moderate symptoms and 103 with severe COVID-19 underwent randomization. Among these patients, 107 received HNS, and 103 moderate cases received a placebo. Fifty severe COVID-19 patients were given HNS, and 53 severe cases received placebo. Administration of HNS led to alleviation of symptoms by day 3 in moderate cases and day 7 in severe cases. “Anti-diabetic, anti-hypertensive, cardio-protective and broncho-dilatory properties of HNS make it even more beneficial in diabetic, hypertensive, cardiac and asthmatic patients who have a higher COVID-19 associated mortality.” HNS could be an affordable, home-based, OTC treatment option for COVID-19 patients The study results show that HNS helped with symptoms alleviation and viral clearance and reduced mortality in patients with moderate and severe disease. According to the team, HNS can be used as a safe and effective therapy in COVID-19 patients as it promotes quicker recovery and survival. Thus, they concluded that HNS represents an affordable therapeutic option and can be used alone or in combination with other therapies to fight COVID-19. Some benefits of this potential treatment option are its ‘over the counter’ availability, affordability – less than $5 for the entire treatment course, and ease of administration as it can be a home-based remedy. Moreover, HNS can also be used in combination with other drugs for increased efficacy. The authors believe that this treatment will significantly reduce the burden on global health care systems. “A multinational study with larger sample size is required to investigate potential variations in responses to the treatment in COVID-19 patients from different racial and ethnic origins.” *Important Notice medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Journal reference: Efficacy of honey and Nigella sativa against COVID-19: HNS-COVID-PK Trial Sohaib Ashraf, Shoaib Ashraf, Muhammad Ahmad Imran, Moneeb Ashraf, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Nighat Majeed, Iqra Farooq, Zaighum Habib, Abubakar Hilal, Zain-ul-Abdin, Ayesha Khaqan, Muhammad Kiwan Akram, Sidra Ashraf, Rutaba Akmal, Sundas Rafique, Khawar Nawaz, Shahroze Arshad, Sohail Ahmad, Kanwal Hayat, Ali Arshad, Muhammad Faisal Nadeem, Muhammad Hassan, Abeer-bin-Awais, Muhammad Azam, Muhammad Suhail, Sibgha Zulfiqar, Imran Anwar, Saulat Sarfraz, Ayesha Hamayoun, Amber Malik, Hui Zheng, Talha Mahmood, Mahmood Ayyaz, Ali Ahmad, Muhammad Ashraf, Qazi Abdul Saboor, Mateen Izhar medRxiv 2020.10.30.20217364; doi: https://doi.org/10.1101/2020.10.30.20217364, https://www.medrxiv.org/content/10.1101/2020.10.30.20217364v2 To read the original article click here.

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Caution, Not Fear: The COVID Death Rate Has Plunged Since April, but Hospitalizations Are Spiking Again

AHA Publisher — Tue, 03 Nov 2020 08:00:41 +0000

Lorie Johnson via CBN News – Hospitals across the nation are pushed to the limit due to a spike in COVID-19 cases. Things are particularly bad in Utah and parts of the Midwest. In El Paso, Texas, the situation is so dire residents face a mandatory 10:00 p.m. curfew to blunt the impact. El Paso’s largest hospital has prepared for the worst by erecting overflow tents in the parking lot in case there aren’t enough beds inside to handle a possible influx of patients. Nationwide, 42,000 people have been hospitalized this week. In Texas, that number surpasses 5,000 – almost double what it was last month. Texas physician Craig DeLisi told CBN News he’s concerned about the rise in hospitalizations. “I think as we see an increase there unfortunately I think we’re going to see an up-tick in deaths as well,” he said. Dr. DeLisi said one reason for the increase in cases and hospitalizations is the cooler weather, which drives people inside where the disease is more easily spread. Also, after seven months of practicing mitigation efforts, people are simply tired of wearing maskings and keeping their distance from others. “Just a general fatigue of people from a caution standpoint,” he said. “Masks are a mixed bag of peoples’ responses. More people would rather leave them than take them and as that happens, naturally we’re going to see more people infected.” Therefore, the doctor prescribes caution, but no fear. “We’re commanded not to be anxious about anything,” he said. “In Philippians, it tells us with prayer and thanksgiving to present our requests to God and he promises the peace of God will rule our hearts and minds in Christ Jesus.” While a lot of attention is focused on increased infections in some places, one often overlooked statistic is the drastic reduction in death rates, a reported 80% since April. According to Johns Hopkins Coronavirus Resource Center, the U.S. death rate now stands at 2.6%, lower than 14 other countries in Europe, South America and the Middle East. Six months ago, patients hospitalized with COVID-19 in the US faced a 25% chance of death. Now doctors are seeing a much lower death rate of 7% among those hospitalized with the virus. “Praise the Lord for that,” said Dr. DeLisi, “There are two reasons for that. One is a better understanding of the disease and the second is better therapeutics.” That includes the anti-viral medication Remdesivir which blocks the replication of the virus. On October 22, 2020, it became the first drug to be approved by the FDA to treat COVID-19. In clinical trials, the drug demonstrated an ability to hasten recovery from the virus. Dexamethasone is another widely used drug that has proven effective in treating COVID-19. The steroid medication has been given Emergency Use Authorization by the FDA and is used to calm the often deadly “cytokine storm,” the over-reaction of the immune system caused by massive inflammation. Both Remdesivir and Dexamethasone were given to President Trump after he was diagnosed with COVID-19. One of the most highly touted drugs given to the president, a polyclonal antibody made by the pharmaceutical company Regeneron, isn’t yet available to the general public, but the FDA could issue an Emergency Use Authorization in the months ahead. President Trump is one of only a couple of hundred people to be given the drug on a Compassion Use basis. The drug stimulates a robust immune response to the virus. In the meantime, hospitals are now using a similar treatment, convalescent plasma, which is antibody-rich blood donated by people who have survived COVID-19. To read the original article click here. For more articles from CBN News click here.

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FDA Approves First COVID-19 Drug: Antiviral Remdesivir

AHA Publisher — Mon, 26 Oct 2020 07:00:56 +0000

Associated Press via CBN News – US regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV. The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health. It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month. Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization. The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness. “We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement. The drug is either approved or has temporary authorization in about 50 countries, he noted. Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial. Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income, and other factors. So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs. To read the original article click here. For more articles from CBN News click here.

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Remdesivir to the Rescue? New Drug Touted by Top Doc as Study Shows It ‘Blocks’ COVID-19

AHA Publisher — Wed, 06 May 2020 07:00:46 +0000

Heather Sells via CBN News – Hopes are rising for a promising experimental drug in the fight against COVID-19. A major study shows that Remdesivir can speed recovery and may reduce the death rate. Experts believe it could have a profound effect on the pandemic since a vaccine is probably at least a year away. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, announced the news at an Oval Office press conference late Wednesday. “We think looking forward this is very optimistic,” he said. The California-based biotech company Gilead Sciences Inc. makes the drug. Researchers initially developed the drug to treat Ebola, but now, a major study shows it helps hospitalized COVID-19 patients recover more quickly from the disease – an average of 11 days compared to 15 for those in a control group receiving a placebo. Those on the drug also showed a trend toward fewer deaths. “The data shows that Remdesivir has a clear-cut, significant positive effect in diminishing the time of recovery,” said Fauci. “It’s a very important proof of concept because what it has proven is that a drug can block this virus.” The US National Institutes of Health ran the study involving 1,063 COVID-19 patients in 22 countries, including the US. Some patients are already praising the drug for speeding their recovery. Chris Kane said he noticed a change after he began taking it. “Within 48 hours I was feeling a lot better,” he said. “I think that Remdesivir gave me the extra jumpstart or kickstart or whatever I needed to kind of turn that corner.” Experts say more study is needed. They are cautiously optimistic about the drug and the NIH study. It has not been peer-reviewed but is being submitted to a journal for review. The FDA says it’s working with Gilead to fast-track Remdesivir, to make it available to patients as quickly as possible, as appropriate. Gilead is ramping up production and plans to have more than 140,000 treatment courses available by the end of May, more than 500,000 by October and 1 million by December. To read the original article click here. For more articles from CBN News click here.

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The Most Promising Strategies for Defeating Coronavirus

AHA Publisher — Sat, 25 Apr 2020 07:00:22 +0000

Frontiers via EurekAlert – In an unprecedented effort, hundreds of thousands of researchers and clinicians worldwide are locked in a race against time to develop cures, vaccines, and better diagnostic tests for COVID-19, the illness caused by the virus SARS-CoV-2. Over 1,650 articles on COVID-19 are already listed in databases such as Google Scholar, while dozens more are added daily. The register ClinicalTrials.gov lists over 460 ongoing clinical trials on COVID-19, although the majority are still in the earliest stages. Given the diversity of experimental approaches among these studies, a systematic review of possible clinical strategies is timely and welcome. In a new study in Frontiers in Microbiology, aimed at the research community but also comprehensible for non-specialists, experts from the University of North Carolina at Chapel Hill review possible strategies against dangerous coronaviruses – not only SARS-CoV-2 and its relatives such as SARS-Cov (causing Severe Acute Respiratory Syndrome, SARS) and MERS-Cov (causing Middle East Respiratory Syndrome, MERS), but also as yet unknown strains which will inevitably emerge in the future. They propose that the most promising approaches for fast progress are selected antivirals such as remdesivir, and gene therapy. “Coronaviruses represent a true threat to human health and the global economy. We must first consider novel countermeasures to control the SARS-Cov-2 pandemic virus and then the vast array of high-threat zoonotic viruses that are poised for human emergence in the future,” says Dr Ralph Baric, William R. Kenan, Jr. Distinguished Professor in the Department of Epidemiology and Professor in the Department of Microbiology and Immunology at UNC Chapel Hill. “To help focus the global search for a treatment, we here aim to provide a comprehensive resource of possible lines of attack against SARS-Cov-2 and related coronaviruses, including the results from all preclinical and clinical trials so far on vaccines against SARS and MERS.” The authors discuss one-by-one the possible strategies against the coronavirus. First, and most effective are vaccines. In the present case, the most successful are likely to carry the Receptor Binding Domain (of the virus’s S-protein), which allows it to bind to and fuse with host cells. Besides the traditional live attenuated, inactivated, and subunit-based vaccines, modern types such as DNA/RNA-based and nanoparticle- or viral vector-borne vaccines should be considered. Because the amino acid sequence of the S-protein is very different across coronaviruses (e.g., 76-78% similarity between SARS-Cov and SARS-Cov-2), vaccines against one strain typically won’t work against another. But because the development and testing of new vaccines takes one to several years, other approaches are essential in the meantime. The second-most likely effective are broad-spectrum antivirals such as nucleoside analogs, which mimic the bases in the virus’s RNA genome and get mistakenly incorporated into nascent RNA chains, stalling the copy process. But because coronaviruses have a so-called “proofreading” enzyme which can cut such mismatches out, most nucleoside analogs don’t work well. Exceptions seem to be β-D-N4-hydroxycytidine and remdesivir, proposed by the authors as good candidates against SARS-Cov-2. Third, convalescent blood plasma from patients who recovered, with low levels of a range of antibodies against the virus; or preferably (but slower to develop), monoclonal antibodies, isolated and mass-produced through biotechnology. Such “passive immunization” can give short-term immunity. The authors discuss a range of options from fusion inhibitors, to inhibitors of human proteases, to immune modulators such as corticosteroid hormones, and others. Finally, and in the authors’ view the most attractive alternative until a vaccine is produced, is gene therapy delivered through the adeno-associated virus (AAV). This would entail the fast, targeted delivery of antibodies, immunoadhesins, antiviral peptides, and immunomodulators to the upper airways, to give short-term protection. Because the rapid turnover of cells here, risks of toxicity are minimal. They estimate that such tools can be developed, adapted, and tested within a month. “AAV-based passive immunization can be used as a quick alternative. It is straightforward and only contains two components, the viral vector and the antibody. Multiple AAV vectors have been proven to be safe and effective for human use,” says author Dr Long Ping Victor Tse. “In theory, a single dose could mount a protective response within a week and last for more than a year. The currently high price could be reduced when treating infectious diseases, which have a larger market. It may or may not already be too late to use AAV to treat SARS-CoV-2, but it is certainly not too late for future outbreaks.” To read the original article click here.

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Investigational Therapy Gaining Reputation as Promising Antiviral Drug to Fight COVID-19

AHA Publisher — Sun, 19 Apr 2020 07:00:15 +0000

Houston Methodist via Newswise – Houston Methodist sole Remdesivir clinical trial site in Houston for treating novel coronavirus. Newswise — COVID-19 patients in a clinical trial at Houston Methodist Hospital are responding quickly to the antiviral drug Remdesivir. The trial’s criteria allows for the treatment of patients early in their clinical course and, in some cases, at times where they might have otherwise been intubated. “Early results are promising, and that is important right now. Much of what we are learning about COVID-19 management is centered around preventing quick deterioration. Timing is everything. I can’t say for certain they would have been intubated otherwise, but it’s encouraging,” said infectious diseases pharmacist Katherine K. Perez, Pharm.D. One of the most challenging things with COVID-19 is the way this virus makes copies of itself once it finds its way into the body. This is how COVID-19 can ultimately take over and send someone into respiratory distress and in need of intubation if not stopped early enough. Remdesivir has demonstrated a potent ability to inhibit this viral replication in human cells and is now being tried in clinical trials of patients with the SARS-CoV-2 virus, which causes COVID-19. Houston Methodist is the only clinical trial site in Houston for this investigational new drug. Working with pharmaceutical company Gilead Sciences, Remdesivir’s manufacturer and sponsor of the studies, Houston Methodist Hospital was the fifth site in the U.S. to join the clinical trials and has been enrolling and treating patients since mid-March. Initially, five patients received early access to Remdesivir on a compassionate use basis, and since being activated as a clinical trial site, more than 35 patients have been enrolled. The two Phase 3 clinical trials at Houston Methodist are randomized, open-label, multicenter studies and are treating patients with moderate to severe symptoms to evaluate the safety and efficacy of Remdesivir in adults diagnosed with COVID-19. One study is for patients with moderate COVID-19 and tests either a 5-day or 10-day Remdesivir treatment. The second study is evaluating a 10-day course of Remdesivir for patients with severe COVID-19, including those on mechanical ventilation. Infectious diseases physician Kevin A. Grimes, M.D., M.P.H., and Perez are leading efforts for both the clinical trials at Houston Methodist and say they’ve been encouraged by the results. Perez says early results at Houston Methodist have been promising, courses have been well tolerated, and a number of COVID-19 patients who have undergone treatment with Remdesivir are showing signs of recovery and have been released from the hospital to go home. While it’s too early to tell, she says there also are indications that treatment with Remdesivir can possibly stave off being intubated. Grimes agrees that acting quickly is critical. “If given early enough, we’re hoping that Remdesivir interferes with the virus and blocks its ability to replicate in patients’ cells,” Grimes said. “The goal is that it staves off the deadly inflammatory cascade that leads to respiratory failure and the need to be intubated and put on a ventilator.” That crucial turning point is what makes COVID-19 become deadly. The main cause of death from this disease results from an extreme inflammatory response in the lungs brought on by the coronavirus. The immune system becomes hyperactive with its inflammatory disease-fighting processes going into overdrive, attempting to defeat the virus, but doing more harm than good by destroying cells in the lungs. A broad-spectrum antiviral drug, Remdesivir was originally developed to treat Ebola more than a decade ago. It’s known to be generally safe in humans and is backed by a large body of preclinical research, as well as a number of studies that have shown it be quite successful in stopping SARS and MERS, the viral cousins of the new coronavirus strain. The testing stopped short of clinical trials, so its efficacy against SARS and MERS in patients is unknown. Published in the journal Nature, a study in China earlier this year showed Remdesivir could successfully block COVID-19 from replicating in human cells. A paper in the New England Journal of Medicine chronicles the case of the man at ground zero in Washington state who was the first known U.S. COVID-19 patient. He received Remdesivir at the recommendation of the CDC and was said to have started improving within 24 hours. On April 10, the first available results from one of Gilead’s compassionate-use cohorts was published in the New England Journal of Medicine. The study showed clinical improvement in a two-thirds majority (68 percent) of patients hospitalized for severe COVID-19 who received compassionate-use Remdesivir. Forthcoming data from several ongoing randomized, controlled clinical trials, including the ones at Houston Methodist, will provide more definitive, evidence-based conclusions regarding the safety and efficacy of Remdesivir for treating COVID-19. The clinical observations in this compassionate-use program are the only currently available data. The study authors expect results from some of Gilead’s controlled clinical trial sites to potentially validate these findings in the coming weeks. To read the original article click here.

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