four treatments tested in a large European clinical trial

In France, more than 800 patients will participate in the coming weeks. The molecules tested all showed some activity on SARS-CoV-2 in vitro.

Didier Raoult, director of the Marseille University Hospital Institute (IHU), published a video in late February in which he presented chloroquine as a miracle treatment against Covid-19.
Didier Raoult, director of the Marseille University Hospital Institute (IHU), published a video in late February in which he presented chloroquine as a miracle treatment against Covid-19. GERARD JULIEN / AFP

A large European clinical trial, called Discovery, is underway to test four candidate treatments for Covid-19. At least 3,200 patients across seven countries will participate (France, Belgium, Netherlands, Luxembourg, United Kingdom, Germany, Spain). In France, at least more than 800 patients will be included in the coming weeks and randomly divided into five groups: four who will receive one of the experimental treatments and one who will receive standard care, including oxygen therapy.

“The medical teams will notify every day of all the characteristics of the patients, whether their clinical state, their viral load or the state of their lungs with a scanner”, explains Pr Florence Ader, head of the trial in France and doctor in the infectious diseases department of the Croix-Rousse-Hospices Civiles de Lyon hospital. “All of this data will allow us to know the efficacy and tolerance (safety, Editor’s note) different treatments. The goal

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the dangers of a hastily developed vaccine

Faced with the emergency, scientists are calling for speeding up testing procedures and doing without the usual animal tests. A laudable strategy, but one that could prove counter-productive at best, and at worst cause death.

While the epidemic is an increase in an endemic disease or the appearance of a large number of patients where the disease was … “data-url =” health / definitions / vie-epidemie-3837 / “data-more =” Read more “>epidemic of Covid-19 continues to gain ground, scientists around the world have embarked on a speed race at vaccine. More than 20 possible candidates are under development, including one from the Institut Pasteur which started testing on mice on March 11. The most advanced is that of Start-ups, digital and biotechnologies
The … “data-image =” “data-url =” https: / / “data-more =” Read more “>start-up Moderna, organized jointly with the NIH (National Institute of Health, American equivalent of Inserm), which started phase 1 trials with volunteers on March 16. A trial started in record time, just a few weeks after the availability of the genome of Sars-Cov-2.

15 to 20 years to develop a vaccine

Normally, get a effective vaccine, non-toxic and usable takes between 15 and 20 years. We must first develop a formula with the chemical and pharmaceutical prerequisites, conduct studies of the factors that influence immunogenicity
The more the response will be strong and induced … “data-image =” “data-url =” https : // “data-more =” Read more “>immunogenicity In animals, assess the This toxicity also depends on the dose of xenobiotic necessary for … “data-image =” /ac93ff44a1_50035323_symbole-toxique-yves-guillo-domaine-public.jpg “data-url =” “data-more =” Read more ” >toxicity of the vaccine in animals, then in humans, and finally, testing its effectiveness on a large scale. But, faced with the emergency, the pressure governments and health authorities, some call for speeding up procedures. European Commission President Ursula von der Leyen said Tuesday she hoped for a vaccine against new coronavirus before’autumn. More reasonably, Moderna promises that its vaccine will be ready at best by mid-2021.

When the vaccine facilitates viral infection

But is it a good idea to skip the steps? A vaccine is not harmless: it is most often a The infection function allows the virus to be introduced into program files, into files … “data-url =” https: // “data-more =” Read more “>virus disabled or weakened, and can in some cases worsen the disease it is supposed to prevent. Peter Hotez, Dean of the National School of Tropical Medicine Baylor College of Medicine and who worked on the SARS epidemic in 2003, found that some vaccinated animals developed examples of symptoms
Symptoms can affect different organs:
muscle, joint pain, headache, digestive problems, vision problems, rashes … “data-image =” /e882bacd5b_96032_symptome-femme-mal-tete.jpg “data-url =” “data-more =” Read more “>symptoms even more severe when exposed to the virus due to a weakened immune system. This is called a “facilitation of infection by the structure of an antibody.
An antibody is a protein complex. If every organism with an immune system codes for billions of different antibodies, they all have the same global characteristics. These are … “data-image =” Antibody-yohan-gfld.jpg “data-url =” https: // “data-more =” Read more “>antibody “(Antibody-dependent enhancement or ADE in English).

Conventionally, the virus initiates the cycle of infection by fixing Roles of proteins
Proteins can perform a wide variety of functions within the cell or organism.
They can have:
a structural role (like actin or tubulin which … “data-image =” -cc.jpg “data-url =” “data-more =” Read more “>protein spike-like viral surfaces to target cell receptors. In doing so, these proteins induce an immune response where surface antibodies will inhibit certain elements of the cell necessary for the virus such as the receptor binding site or the. We speak of dipeptides, tripeptides when … “data-url =” “data-more =” Read more “>peptide of The melting point of water, in other words the temperature at which the ice … “data-image =” /d/0/7d0df59f3c_82086_fusion.jpg “data-url =” “data-more =” Read more “>fusion. However, in certain circumstances, these antibodies will on the contrary bind with the tips of the virus and facilitate their entry into the cell, or cause a replication and increased infection.

The best known example is that of a vaccine against respiratory syncytial virus (RSV, against Bronchiolitis, a childhood respiratory infection
Bronchiolitis … “data-image =” “data-url =” https: // news. “data-more =” Read more “>bronchiolitis) developed by Pfizer in the 1960s, which led to several serious cases pneumonia in children, resulting in the deaths of two of them. The same phenomenon has been reported with a dengue vaccine from Sanofi or the West Nile virus. It is also seen in animals for the Flu Agent
The infectious agent is a virus from the Orthomyxoviridae family, the genome of which consists of eight RNA segments. These RNAs are grouped in the same viral particle, … “data-image =” “data -url = “” data-more = “Read more”>influenza, Zika virus… and the coronavirus like the Sars.

Reliable animal models too long to develop

The exact mechanisms of these side effects and why some people are affected and others are not yet known. ” But the best way to insure against this risk is to test the vaccine on animals “, Assures Peter Hotez to the agency Reuters. And this is where the second problem arises. Because to have tests that can be extrapolated to humans, you must first obtain mouse lines that have been genetically engineered to match their immune response to that of humans.

A process which takes a lot of time and which Moderna did without. The company points out that its vaccine poses a lower risk of facilitating infection by antibodies, because it only uses proteins from viral surfaces, and not a whole virus deactivated. However, neither Moderna nor a good number of start-ups in the race have never produced a vaccine, which leaves a doubt on their ability to grasp the phenomenon.

There is no reason to put people at risk in a study for an ineffective vaccine

Speed ​​versus security, an assumed choice

There is no reason to put people at risk in a study for a vaccine ineffective “Warns Karen Maschke, researcher at the Hastings Center, a non-partisan think tank, on the site STAT. ” If, against all odds, this hasty project works, then society will have to be even more attentive in monitoring and tracking the people who benefit from it. “Adds Arthur Caplan, head of medical ethics at Grossman School of Medicine from New York University. Arguments that do not seem to outweigh the panic triggered by the Covid-19 epidemic.

In a closed meeting, officials from the World Health Organization (Health: what is WHO?
As stated in its constitution, WHO aims to bring all people to the highest level of health … “data-image =” images / midioriginal / c / 0/3 / c0318e9153_101519_oms-logo.jpg “data-url =” “data-more =” Read more “>WHO) have agreed to allow testing on humans before results on animals are known, reports a Reuters participant. The institutions are said to be ready to assume the risk of a few serious cases in exchange for a quick vaccine that will, at best, not be available until the peak of the epidemic.

What you must remember

  • Laboratories around the world have embarked on a speed race for the Covid-19 vaccine, even without the usual tests in animals.
  • These vaccines can then, in some cases, facilitate infection with the virus and lead to worsening of symptoms.
  • Companies also lack reliable animal models for testing their vaccines.
  • The urgency and the pressure are such that these risks are no match.

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The FDA expands coronavirus tests after CDC defects undermine the fight against disease

The effort of the U.S. Centers for Disease Control and Prevention to protect Americans from the new coronavirus has been hampered by a poor disease test and limited access to reliable analysis, resulting in significant delays in determining which people have the virus, according to officials and experts.

But the Food and Drug Administration announced Saturday that labs and hospitals across the nation will now be able to conduct the tests and will not have to wait for the results of the CDC.

“We believe this policy strikes the right balance during this public health emergency,” said FDA commissioner Dr. Stephen Hahn in a note. “We will continue to help ensure solid science before clinical trials and follow-up with independent critical review by the FDA, rapidly expanding testing capabilities in the United States.”

The anomalies in the CDC test system contrasted the wide-ranging surveillance tests to track the disease and eliminate concerns for healthy people by simply fighting a common cold.

China currently has the ability to test 1.6 million people per week for COVID-19 and South Korea has already tested around 65,000 people, according to Science Magazine. As of Friday, fewer than 500 people in the United States had been tested, according to the CDC.

The CDC has ignored the World Health Organization’s testing guidelines to design its own test. But several test kits sent to states have had inconclusive results, so most states have had to rely on CDC analysis, creating a backlog, according to ProPublica.

“We are weeks behind because we had this problem,” Scott Becker, chief executive officer of the Association of Public Health Laboratories, told ProPublica. “Usually we are in the foreground, in the center and ready.”

Until recently, the CDC has also limited the use of kits to suspected cases of COVID-19 among people who had traveled to China within two weeks of developing symptoms or who had been in close contact with someone with the disease.

A Washington County health director, where the nation’s first coronavirus fatality occurred, complained on Saturday of the delay in critically identifying people with the disease caused by blocking tests and strict CDC criteria before they could even conduct a test.

“If we had had the chance to run the tests earlier, I’m sure we would have identified the patients earlier,” said Jeff Duchin. Early detection is critical for people to be able to start treatment and be isolated before passing on the virus to someone else.

Washington state officials announced two new cases of illness on Friday, the death of a coronavirus man on Saturday and an apparent outbreak of COVID-19 in a nursing home in the Seattle area where two people have already given positive results and dozens of others have symptoms.

This week New York and the state got permission from CDC and FDA to develop their tests in an attempt to simplify the process. CDC said that the tests it provides should offer reliable reading on COVID-19 in many laboratories, although other elements of the test may not work. But New York officials aren’t convinced they can rely on the results of the CDC tests.

“Tests for coronavirus are not yet available in New York City,” said Department of Health spokeswoman Stephanie Buhle in an email to ProPublica. “The kits that have been sent to us have shown performance issues and cannot be relied on to provide an accurate result.”

Dozens of state, university and private company labs have already applied for emergency approval for their tests. Once they have presented evidence of how these tests work, they will be able to use them immediately, according to the New York Times.

President Donald Trump at a press conference on Saturday announced measures to block visitors to the United States from countries hit hard by the virus and encouraged Americans not to travel to those countries. He did not address the test problem.


Combination of effective immunotherapy drugs for patients with fast growing neuroendocrine tumors

Many patients with rare and rapidly growing neuroendocrine tumors respond well to a common combination of immunotherapy drugs, according to DART’s first peer-reviewed publication, short for Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors, one unique clinical study on rare cancer.

DART offers the combination of ipilimumab and nivolumab immunotherapy to patients with 53 rare tumor classes through an innovative “basket” design, which allows testing of a single drug or combination of drugs in a variety of tumor types. The study rapidly expanded the opportunities for developing immunotherapy drugs in rare cancers, which account for almost a quarter of all diagnosed cancers worldwide.

DART is managed by the SWOG Cancer Research Network, a group of clinical trials that is part of the National Cancer Institute (NCI) National Clinical Trials Network (NCTN), the oldest and largest publicly funded cancer research network in the United States.

The results of the study appear in Clinical cancer research. When they were presented in March 2019 during the American Association of Cancer Research annual meeting, the initial results were greeted with enthusiasm. This is because patients with high-grade or fast-growing neuroendocrine cancer have few treatment options.

We are very encouraged by these results. Based on the response, we opened another study that only enrolled patients with high-grade neuroendocrine carcinoma to see if we can replicate our results. We look forward to sharing these results later this year. “

Sandip Pravin Patel, MD, the DART clinical study chair, associate professor of medicine at the University of California at the San Diego School of Medicine and a medical oncologist with Moores Cancer Center at UC San Diego Health

Patel’s other DART chairs are Razelle Kurzrock, MD, from UCSD Moores Cancer Center and Young Kwang Chae, MD, PhD, from Northwestern University.

For this neuroendocrine cohort, 32 eligible patients received the combination ipilimumab and nivolumab. Of the 32, 18 had high-grade carcinoma, with tumors that most commonly appear in the lungs or gastrointestinal tract. Regardless of where their tumors appeared, eight out of 18 high-grade patients – or 44 percent – saw them partially or completely shrink. In contrast, patients with intermediate or low-grade tumors saw no response.

Since its launch in 2017, doctors from 823 cancer centers, academic and clinical clinics, and community hospitals have opened DART. As of February 13, 715 patients signed up with a goal of 818: beat all expectations. Historically, rare cancer studies have found it difficult to find patients, leading many researchers to abandon research on rare cancer.


Journal reference:

Patel, S.P., et al. (2020) A phase II basketball trial of double block Anti-CTLA-4 and Anti-PD-1 in rare cancers (DART SWOG 1609) in patients with non-pancreatic neuroendocrine tumors. Clinical cancer research.


The antifibrinolytic agent could be a treatment for bloody stroke

A common bleeding-reducing drug could be a treatment for bloody stroke, particularly if administered quickly, according to advanced science presented today at the American Stroke Association’s International Stroke Conference 2020. The conference, February 19-21, is in Los Angeles, a worldwide meeting for researchers and clinicians dedicated to stroke science and brain health.

The Spot Sign and Tranexamic acid on the prevention of IC ICH growth). ICH is a severe form of acute stroke with few treatment options.

Tranexamic acid is currently used to treat or prevent excessive blood loss from trauma, surgery, tooth removal, nosebleeds and heavy menstruation. For this study, one hundred patients with active brain hemorrhage received intravenous tranexamic acid or placebo within 4.5 hours of symptom onset. Researchers analyzed brain CT scans performed during the 24-hour period after treatment with tranexamic acid or placebo.

Researchers found a trend towards reduced bleeding expansion in the tranexamic acid group, especially those treated within 3 hours of cerebral hemorrhage. However, this trend was not statistically significant. The finding was consistent with previous research on the use of the drug.

Further studies with tranexamic acid are underway and focus on ultra-early treatment – within 2 hours. This is where there seems to be the greatest opportunity for intervention.

Tranexamic acid is inexpensive, safe and widely available. Our results and others provide a great impetus for further targeted research using this treatment. “

Nawaf Yassi, M.B.B.S., B.Sc., Ph.D., experimental investigator and consultant neurologist at Royal Melbourne Hospital

Larger studies focusing on patient outcomes are needed for this therapy to enter routine clinical practice.


American Heart Association

Published in: Medical Research News | News on medical conditions Pharmaceutical news

Tags: Bleeding, Blood, Brain, Clinical Study, CT, Disability, Health Care, Heart, Hospital, Intracerebral Hemorrhage, Medical Research, Menstruation, pH, Placebo, Research, Stroke, Surgery, Tranexamic Acid, Trauma