| Topic: | Slight correction and amplification | |
| Posted by: | Mark Julian Raymond | |
| Date/Time: | 11/04/20 22:02:00 |
A slight correction, the Oxford University 'Recovery Trial' involves three treatments including hydroxychloroquine and not three treatments and hydroxychloroquine as I wrongly said previously. The following three pieces are worth reading, the third Daily Mail piece puts the 'Trump study' in perspective, Thursday, April 9, 2020 NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins Oxford recruits 2,700 virus patients for fast-growing drugs trial ‘Recovery’ will evaluate existing medicines that might be effective against Covid-19 Clive Cookson, Financial Times, Friday 10th April 2020 https://www.ft.com/content/f4e3055e-72e2-459d-ba66-05af7d2c8915 Publisher of hydroxychloroquine research touted by Trump as a 'game changer' says the paper 'did not meet its standards' because it EXCLUDED data on patients who did not respond well to the treatment Daily Mail, Friday 10th April https://www.dailymail.co.uk/health/article-8205773/Publisher-hydroxychloroquine-study-hailed-Trump-said-complete-failure.html IN SOME MORE DETAIL Oxford recruits 2,700 virus patients for fast-growing drugs trial Oxford recruits 2,700 virus patients for fast-growing drugs trial ‘Recovery’ will evaluate existing medicines that might be effective against Covid-19 ‘Recovery’ will evaluate existing medicines that might be effective against Covid-19 The ‘Recovery’ trial is evaluating existing medicines that might be effective against coronavirus ‘Recovery’ is the largest of many Covid-19 trials under way around the world © Cyril Marcilhacy/Bloomberg The fastest-growing clinical trial in medical history has enrolled more than 2,700 Covid-19 patients in UK hospitals to test potential treatments for coronavirus disease — and thousands more are likely to join over the next few weeks. Peter Horby, professor of infectious diseases at the University of Oxford, who is leading the project, said no controlled clinical trial — in which people are assigned at random to receive different drugs and the results compared — had ever expanded so quickly and on such a large scale. “We need to recruit very fast while the epidemic is approaching its peak, so that we have enough patients to provide firm data,” he said. The trial is called Recovery, a somewhat tortured acronym for randomised evaluation of Covid-19 therapy. Prof Horby was involved in clinical trials carried out during the early weeks of the coronavirus epidemic in China. These generally ended up with too few subjects to provide firm evidence, he said, because the Chinese government’s clampdown on Covid-19 reduced transmission of the virus very quickly. Scientists have not had nearly enough time to develop new treatments specifically for Covid-19, so Recovery is evaluating existing medicines that might be effective against coronavirus. Professor Peter Horby said no controlled clinical trial had expanded so quickly and on such a large scale © Fisher Studios The trial started by examining three treatments recommended by an expert panel advising the chief medical officer. They are: the lopinavir-ritonavir combination used to treat HIV; dexamethasone, a steroid that reduces inflammation; and hydroxychloroquine, the malaria medicine. Patients arriving at 130 NHS hospitals across the UK with confirmed Covid-19 are invited to take part. They are allocated randomly to four groups. Three are given one of the trial treatments and the fourth — the control group — just receives standard medical care. “We can add further medicines to the trial within days,” said Prof Horby. “This week we are adding azithromycin, an antibiotic with anti-inflammatory properties.” Thursday, April 9, 2020 NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins Novel Coronavirus SARS-CoV-2 Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-COV-2 virus particles (purple), isolated from a patient sample. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.NIAID A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has begun, with the first participants now enrolled in Tennessee. The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The first participants have enrolled in the trial at Vanderbilt University Medical Center, Nashville, one of dozens of centers in the PETAL Network. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine. “Effective therapies for COVID-19 are urgently needed,” said James P. Kiley, director, Division of Lung Diseases, NHLBI. “Hydroxychloroquine has showed promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19.” Daily Mail, 10th April Publisher of hydroxychloroquine research touted by Trump as a 'game changer' says the paper 'did not meet its standards' because it EXCLUDED data on patients who did not respond well to the treatment A small-scale French study said it found that hydroxychloroquine could reduce the duration of coronavirus in patients President Trump has hailed the drug - in combination with azithromycin, an antibiotic - a game changer in treatment The medical society that published the research now says it 'does not meet the Society's expected standard' Researchers did not include data about six of the 26 patients that 'left' the study and did not explain what 'virologically cured' meant By Mary Kekatos Senior Health Reporter For Dailymail.com Published: 21:52, 9 April 2020 | Updated: 07:20, 10 April 2020 The publisher of the French study that found hydroxychloroquine could help treat coronavirus patients is now saying the paper 'did not meet its standards.' President Donald Trump has hailed the research in tweets and during his daily press conferences as a 'game changer.' But in a statement published online, the International Society of Antimicrobial Chemotherapy (ISAC) addressed several new concerns with the research. Officials say they found out the researchers excluded data on patients who didn't respond well to the treatment and that they did not clarify what they meant when they said patients were 'virologically cured.' A small-scale French study said it found that hydroxychloroquine (file image) could reduce the duration of coronavirus in patients President Donald Trump has hailed the drug - in combination with azithromycin, an antibiotic - a game changer in treatment. President Donald Trump has hailed the drug - in combination with azithromycin, an antibiotic - a game changer in treatment. Pictured: Trump speaks about the coronavirus at the White House, April 8 The medical society that published the study now says it 'does not meet the Society's expected standard' because researchers did not include data about six of the 26 patients that 'left' the study and did explain what 'virologically cured' meant. The medical society that published the study now says it 'does not meet the Society's expected standard' because researchers did not include data about six of the 26 patients that 'left' the study and did explain what 'virologically cured' meant. The study was first published online in ISAC's journal, the International Journal of Antimicrobial Agents, on March 20. Researchers from the Méditerrannée Infection University Hospital Institute in Marseille, France, had 20 patients take hydroxychloroquine in combination with azithromycin, an antibiotic. They found the the combination was linked to 'viral load reduction/disappearance in COVID-19 patients.' The team began with 26 patients but six were 'lost in follow up during the survey because of early cessation of treatment,' according to the study. Three of the six ended up in the intensive care unit, a fourth patient died, one stopped treatment after experiencing nausea and the last ended up not having the virus. In the US, there are more than 435,000 confirmed cases of the virus and more than 14,000 deaths In the US, there are more than 435,000 confirmed cases of the virus and more than 14,000 deaths 'Although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices,' Andreas Voss, the president of the society, wrote in a statement. He then made note that one of the study's authors, Jean-Marc Rolain, is editor-in-chief of the journal in which it was published. 'Despite some suggestions online as to the reliability of the article's peer review process, the process did adhere to the industry's peer review rules,' Voss wrote. 'Given his role as Editor in Chief of this journal, Jean-Marc Rolain had no involvement in the peer review of the manuscript and has no access to information regarding its peer review.' Voss did not immediately reply to DailyMail.com's request for comment. Arthur Caplan, a bioethics professor in the department of population health at NYU School of Medicine, called the study 'pathetic' especially because the results of the six patients that were dropped [were not factored into the study's final conclusions.] 'I think [the research is] based on a pathetic study that lost six of the 26 patients,' Caplan told DailyMail.com. 'It hid data. It got retracted because it was a farce.' |