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]]>The post Preliminary dexamethasone data published for ‘life-saving’ coronavirus drug appeared first on Virus Reports.
]]>After researchers at the University of Oxford recently deemed dexamethasone as a “life-saving” drug treatment for COVID-19, some experts wanted to see additional data.
The preliminary results of the study were announced on June 16, but they were not published until Monday in the medRxiv depository.
They have not yet been peer-reviewed.
Researchers said the RECOVERY trial “provides clear evidence” that treatment with dexamethasone, which is also a steroid, 6 mg once daily for up to 10 days, was found to reduce deaths in patients receiving oxygen by one-fifth and those on ventilators by one-third.
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Based on these results, the drug would prevent one death of approximately eight patients on ventilators, and around 25 patients needing oxygen, researchers wrote. No benefit was seen in hospitalized COVID-19 patients who do not need oxygen.
“Dexamethasone provides an effective treatment for the sickest patients with COVID-19 and, given its low cost, well understood safety profile, and widespread availability, is one that can be used worldwide,” researchers wrote.
The study, known as the RECOVERY Trial, enrolled 11,320 patients in England, Scotland, Wales and Northern Ireland. Some 2,104 patients were randomly assigned to get the drug, while another 4,321 patients received usual care.
The mean age of study participants was 66.1 years and more than half of patients had at least one major comorbidity.
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Around 15 percent of all UK hospitalized patients with COVID-19 were enrolled in the trial.
Without reliable evidence from large-scale randomized clinical trials, researchers noted a lot of uncertainty about the effectiveness of corticosteroids in COVID-19. However, corticosteroids have been widely used in syndromes closely related to COVID-19, including SARS, MERS, severe influenza, and community-acquired pneumonia, they wrote.
“It is likely that the beneficial effect of corticosteroids in severe viral respiratory infections is dependent on using the right dose, at the right time, in the right patient,” study authors wrote.
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Prior to RECOVERY, many COVID-19 treatment guidelines stated that corticosteroids were either “contraindicated” or “not recommended” although in China, corticosteroids are recommended for severe cases, study authors noted.
The trial was conducted at 176 National Health Service (NHS) hospital organizations in the UK. The funding for the study was provided by the U.K. government, as well as private donors, including the Bill and Melinda Gates Foundation.
Fox News’ Chris Ciaccia contributed to this report.
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]]>The post Preliminary Data Suggests Low-Dose Radiation May Be Successful Treatment For Severe Covid-19 appeared first on Virus Reports.
]]>Human medical trials have begun on severely ill COVID-19 patients using low-doses of radiation. The first results on a very small group were published this week in a non-peer-reviewed journal that exists to get critical results out quickly to the scientific and medical community.
The medical team at Emory University Hospital led by Dr. Mohammad Khan (on the right; Dr. Clayton … [+] Hess is on the left, shown on the first day of the Low Dose human trial) is the first to demonstrate how low doses of radiation can treat COVID-19. Delivering a low dose of radiation to any part of the body is routine and using radiation to treat COVID-19 is simple – no new preparation, additional equipment, or training is needed. We do it all the time. And it seems to be working.
The results were quite extraordinary.
Researchers at Emory University Hospital, led by Dr. Mohammad Khan, Associate Professor of Radiation Oncology, treated five COVID-19 patients with severe pneumonia who were requiring supplemental oxygen and whose health was visibly deteriorating. Their median age was 90 with a range from 64 to 94, four were female, four were African-American, and one was Caucasian.
These patients were given a single low-dose of radiation (1.5 Gy) to both lungs, delivered by a front and back beam configuration. Patients were in an out of the Radiotherapy Department in 10 to 15 minutes.
Within 24 hours, four of the patients showed rapid improvement in oxygenation and mental status (more awake, alert and talkative) and were being discharged from the hospital 12 days later. Blood tests and repeated imaging of the lungs confirmed that the radiation was safe and effective, and did not cause adverse effects – no acute skin, pulmonary, gastrointestinal or genitourinary toxicities.
The gray (Gy) is a dose unit of ionizing radiation defined as the absorption of one joule of radiation energy per kilogram of matter. The Gy replaces the older unit of the rad, and 1 Gy = 100 Rad.
This treatment is critical because severe COVID-19 cases cause cytokine release syndrome, also known as a cytokine storm. Such a storm is a deadly uncontrolled systemic inflammatory response of the body’s immune system resulting from the release of great amounts of pro-inflammatory cytokines, which act as a major factor in producing acute respiratory distress syndrome, or ARDS, which is what kills.
It’s why we need ventilators and ICU beds so badly, and why this pandemic threatens to overwhelm our hospital systems.
One reason why this trial is so important, and why the success rate was so exciting, is COVID-19’s increasing fatality rates with age – 8% for patients aged 70 to 79 and 14.8% for those aged 80 and over – so showing this treatment is safe and effective for these elderly patients was vital. Mortality rates are even higher if you get hospitalized and are in the ICU, over 50%.
It’s the anti-inflammatory effects of radiation, not its antiviral action, and it’s these anti-inflammatory effects that is invaluable in helping patients with COVID-19 and that were demonstrated in this trial.
We are already completely set up for these radiation treatments at almost every hospital and cancer center – no new preparation, additional equipment, or training is needed. There is no supply chain issue with this treatment.
As discussed previously, several medical institutions are starting radiation therapies for COVID-19. The Clinicaltrials.gov website gives information on these trials, including an Italian clinical trial, a Spanish clinical trial and others that have begun and more have recently been added to the ClinicalTrials.gov website, with five of them currently recruiting patients. The countries represented are USA(2), Spain(2), Italy (1), Iran(1), and India (1).
Dr. James Welsh at Loyola University Medical Center, and former Chairman of the Board of the American College of Radiation Oncology and Editor-in-Chief of the Journal of Radiation Oncology, is moving to begin a national trial within the next few months on this treatment using low-dose radiation to the lungs. His research group just published an article on the basic science behind this method.
We kind of knew this would work because we did the same thing 70 to 80 years ago. Dr. E. J. Calabrese at the University of Massachusetts School of Public Health & Health Sciences and Dr. Gaurav Dhawan at the University of Massachusetts reviewed how X-ray therapy was used during the first half of the 20th century to successfully treat pneumonia, especially viral pneumonia like that caused by this coronavirus.
These studies indicated that the possible mechanism by which low doses of radiation mitigates inflammation and facilitates healing is via the polarization of macrophages to an anti-inflammatory or M2 phenotype. The M1 type tends to overstimulate the immune system which can lead to a cytokine storm, while the M2 type tends to suppress the overreaction of the immune system.
As the other human radiation trials move forward, it will be exciting to see the results because we need an easy, quick and safe treatment for the most dangerous virus of our time.
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]]>The post Preliminary Study Claims To Have Discovered The First Significant Mutation In The SARS-CoV-2 Pathogen appeared first on Virus Reports.
]]>A preliminary study reports that a significant mutation in the SARS-CoV-2 pathogen may have been detected for the first time. Authors of the study, published on the website bioRxiv and not yet peer-reviewed, posit that if the mutations continue to occur, it could impact efforts to find a vaccine, but they told Newsweek they think this is unlikely due to the genome’s relatively stable nature compared to the SARS coronavirus.
The study looked at the genetic makeup of 106 samples of the Covid-19 pathogen from a database compiling information taken from infections across the globe. They then compared the information on the Covid-19 coronavirus with 39 genome sequences of the SARS coronavirus. SARS causes severe acute respiratory syndrome, which saw an outbreak in 2002.
Their investigations revealed that, despite having had a smaller impact on humanity, SARS actually contained higher genetic diversity with a greater rate of mutation compared to the Covid-19 pathogen, which was found to have a comparatively stable genome. The “first significant” mutation they did encounter was from a sample collected in India on January 27, 2020, which showed an alteration to the genome that appeared to make the pathogen less able to bind to a receptor on human cells called ACE2.
“A relatively stable genome of SARS-CoV-2 is a good indication for the epidemic control, as less mutation raises the hope of the rapid development of [a valid] vaccine and antiviral drugs,” wrote the authors.
The seasonal influenza (flu) has long been a headache for epidemiologists as a high mutation rate means that vaccinations become invalid from one flu season to the next (though there is promise that a universal vaccine may now be on the cards). Vaccines help the body to fight off serious illness by training our immune systems to recognize the pathogen once it enters our bodies. If the pathogen has mutated too significantly since the vaccine was developed, our immune cells won’t be able to recognize it and we’ll experience a more significant bout of illness.
If the SARS-CoV-2 genome is indeed stable, as the researchers believe their investigations indicate, then the mutation doesn’t necessarily spell bad news for vaccination efforts. A promising finding from the study was that the spike protein, which is a key feature that enables it to attack human cells, had stayed the same after the mutation.
The study has not yet undergone peer review, a vigorous process that establishes the methodology and results of the study are accurate. While this kind of publishing can help spur discussions, it also means concrete conclusions must be suspended until the research is validated.
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