Sunday, May 31, 2020

Antibody Treatment, Showing Improvement in Recovery Time

  • Pre-clinical data for Celltrion’s antiviral antibody treatment candidate demonstrate a 100-fold reduction in viral load of SARS-CoV-2 (COVID-19), as well as improvement in lung lesions
  • The antiviral activity at the pre-clinical stage indicates Celltrion’s candidate could be a potential treatment for COVID-19 if the results are replicated in clinical trials
  • The first in-human clinical trials for Celltrion’s antiviral antibody candidate are set to start in July
 
INCHEON, South Korea--()--Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models.
The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed.
Reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis were used to analyse specimens from the upper respiratory tract (nasal discharge and nasal turbinate) and the lungs. The samples from the high-dose group saw the viral load reduce by 100-fold. Furthermore, lung biopsy showed that both dosage groups saw inflammation returning to normal lung tissue histopathology within 6 days as well as a shortened recovery time, whereas the placebo-controlled group experienced sustained levels of lung inflammation and complications.
This announcement follows the identification of antibody candidates for an antiviral treatment which Celltrion completed in April. In response to these positive results, Celltrion will now conduct additional efficacy and toxicity testing in pre-clinical settings and anticipates starting first-in-human clinical trials in July.
“Celltrion is drawing on its expertise, innovation and previous experience in coronaviruses, such as efforts researching the efficacy of CT-P38, an investigational antibody to treat Middle East Respiratory Syndrome (MERS), as well as CT-P27, a multi-antibody drug for influenza which is being tested in a phase 2b study, to develop a safe and effective treatment for COVID-19,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “Celltrion is leveraging its advanced technologies to lead efforts to develop a novel antiviral antibody treatment containing potent therapeutic antibodies that can neutralise the virus. Celltrion hopes to commence first-in-human clinical trials in July and has the capability to roll out mass production of the therapeutic antibody treatment once it is ready.”

Coronavirus Update: Should You Wear a Face Mask at Home?

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courier keeping global organ transplants alive

Night after night on flights, wearing same jeans for weeks

70 days in airports: The courier keeping global organ transplants alive

Delivering for recipients of bone marrow donor registry, Mishel Zrian sleeps in airport lounges, receives his deliveries without being forced to quarantine. He just can’t go home

In this May 19, 2020, photo, Israeli courier, Mishel Zrian carries a bone marrow transplant donation at Ben Gurion airport near Tel Aviv, Israel. Over the past two months, as air travel has ground to a halt, Zrian has criss-crossed the Atlantic and the United States dozens of times, sleeping in empty airports and unable to return home to see his family in Israel, all in a race against time to deliver life-saving transplants. (AP Photo/Sebastian Scheiner)
In this May 19, 2020, photo, Israeli courier, Mishel Zrian carries a bone marrow transplant donation at Ben Gurion airport near Tel Aviv, Israel. Over the past two months, as air travel has ground to a halt, Zrian has criss-crossed the Atlantic and the United States dozens of times, sleeping in empty airports and unable to return home to see his family in Israel, all in a race against time to deliver life-saving transplants. (AP Photo/Sebastian Scheiner)
PETAH TIKVA, Israel (AP) — Over the past two months, as air travel ground to a halt, Mishel Zrian has crisscrossed the Atlantic and the United States dozens of times, sleeping in empty airports and unable to return home to see his family in Israel, all in a race against time to deliver life-saving transplants.
Zrian is a courier hired by Israel’s Ezer Mizion bone marrow donor registry, which has had to perform logistical acrobatics to get its transplants to their destinations amid the travel disruptions caused by the pandemic. The nonprofit, as well as others involved in coordinating transplants around the world, has been tested by the shortage of flights and restrictions on travel, forced to find creative solutions or risk the health of patients.
“It’s been a struggle the entire time but at the back of our minds always is that the patient must receive this transplant or else he will die,” said Bracha Zisser, director of Ezer Mizion, the world’s largest Jewish bone marrow donor registry.
With the coronavirus upending air travel and countries shutting down borders to prevent the influx of infected travelers, airlines have been forced to drastically cut services, leaving those who still rely on commercial flights scrambling for ways around the logjam.
For those in need of a bone marrow transplant — usually cancer patients — finding the right DNA match is difficult and often requires the help of international donors.
In this May 19, 2020 photo, a nurse holds bone marrow for transplant at the Israeli Ezer Mizion bone marrow registry, in the Israeli central city of Petah Tikvah. (AP Photo/Sebastian Scheiner)
Timing is critical. At the start of the transplant process, the patient’s own bone marrow is removed; if the transplant is not provided within 72 hours, the patient could die.
Ordinarily, delivering a bone marrow transplant to a far-flung destination is simple. But according to the World Marrow Donor Association, donor registries and transplant centers around the world have been grappling with how to navigate the new rules under coronavirus restrictions.
In one case, an Italian military plane was called up to deliver a transplant from Turkey to a 2-year-old patient in Rome. Germany, Italy and the US set up special exchange points at military bases to allow couriers to drop off and pick up transplants there rather than have them enter the country by way of civilian airports.
As flights to Israel became scarce, Ezer Mizion’s transplants were sent to Europe via Belgium by cargo flights and then driven to their final destination. A daily commercial flight out of Israel to the US has allowed the organization to continue its deliveries, but within the confines of the chaos wrought by the pandemic.
In this May 19, 2020 photo, Israeli courier Mishel Zrian, right, receives bone marrow at Ben Gurion airport near Tel Aviv, Israel. Over the past two months, as air travel has ground to a halt, Mishel Zrian has criss-crossed the Atlantic and the United States dozens of times, sleeping in empty airports and unable to return home to see his family in Israel, all in a race against time to deliver life-saving transplants. (AP Photo/Sebastian Scheiner)
Zrian, the nonprofit’s main US-bound courier, left Israel for what was supposed to be a brief journey in mid-March, only to be told upon his return that he would need to remain in quarantine for 14 days, according to Israeli rules on all incoming travelers.
At that point, Ezer Mizion appealed to the Israeli Health Ministry and the National Security Council, and managed to secure Zrian special entry to the country, as long as he didn’t leave the airport.
He is allowed to sleep in an airport lounge between flights and receive his deliveries without being forced to quarantine. With airport restaurants closed, Zrian subsists on fast food while in the US. When he returns to Israel, he gets to have more lavish meals at the airport lounge.
But he can’t go home.
The 47-year-old hasn’t seen his two teenage sons in more than 70 days, and his wife was only granted one airport visit during that time. In the US, he has been given special clearance to enter on the grounds that he is an essential worker.
Zrian, who works for courier company Royale International, has flown with his precious cargo more than 50 times since mid-March, often the only passenger on the plane and landing at deserted airports. While he sometimes sleeps at his destination, his life moves to the beat of his deliveries. He recently spent six straight nights on flights. He’s been wearing the same pair of jeans for weeks, he said, washing them in hotel bathtubs when he gets the chance.
“I miss my family,” he said. “But I always carry the transplant with me and I know I am doing the right thing.”
In this May 19, 2020 photo, an Israeli man donates bone marrow for transplant at the Israeli Ezer Mizion bone marrow registry, in the Israeli central city of Petah Tikvah. (AP Photo/Sebastian Scheiner)
In one delivery, destined for Oslo, Zrian boarded a cargo flight to Belgium, where another courier was set to drive the transplant 14 hours to Norway. When pilots he encountered offered him a seat on a direct flight to Oslo, which would save several crucial hours, he jumped at the chance.
But with flights from Europe to Israel nearly at a standstill, Zrian had to make a roundabout journey through Frankfurt and then New York to be able to get back to Israel.
The drop in flights has also affected the US, where kidneys, the most common transplant in America, are often flown across the country and need to reach patients within 30 hours. The longer a kidney is out of a body, the more its condition deteriorates. Other organs typically travel on private planes.
According to Dorry Segev, a professor of transplant surgery at Johns Hopkins University, the travel disruption is likely leading to delays, which affects the quality of the kidney and could prompt some patients to postpone the care they need.
“We don’t have our commercial flight infrastructure in the United States, which kidney transplantation rides on the back of,” he said. “It’s very chaotic.”
Rick Hasz, of the Philadelphia-based Gift of Life Donor Program, said kidneys were still reaching their destinations, although with different preservation techniques and additional planning.
Zisser, of the Israeli nonprofit, said none of the dozens of deliveries made over the past two months has missed its deadline.
“The idea of saving a life was always in our hearts,” she said, “and we were willing to do everything for that.”

Scientist posits ‘wild’ hypothesis that cross immunity could slow pandemic

WHO expresses caution on whether there may be protection from prior exposure to some cold viruses; scientists examine if some people are more vulnerable to infection than others

A medical worker takes a swab from a foreign reporter who was selected to cover the closing session of the Chinese People's Political Consultative Conference (CPPCC) for the coronavirus test, at a hotel in Beijing, May 27, 2020. (Andy Wong/AP)
A medical worker takes a swab from a foreign reporter who was selected to cover the closing session of the Chinese People's Political Consultative Conference (CPPCC) for the coronavirus test, at a hotel in Beijing, May 27, 2020. (Andy Wong/AP)
PARIS (AFP) — Could exposure to the coronaviruses that cause the common cold help protect against COVID-19? Is herd immunity closer than previously thought?
As nations lift lockdowns and experts worry about a potential second peak in cases, our ability to ward off infection is one of the hottest topics of scientific debate.
Ever since it became apparent that children were less vulnerable to COVID-19 early in the pandemic, scientists have speculated that the regular spread of benign viruses in places like schools could have bolstered their immune response to the latest coronavirus.
Now the idea of “cross immunity” among the broader population is gaining some ground.
Some people wear face masks to help curb the spread of the coronavirus stroll along the Champs Elysees avenue in Paris, May 16, 2020 (AP Photo/Michel Euler)
In a recent post on Twitter, Francois Balloux of University College London noted an “intriguing” lack of an immediate resurgence in COVID-19 cases following the easing of lockdowns in several countries.
Francois Balloux (Twitter)
Among the possible explanations, he noted, were seasonality and enduring social distancing practices.
But he posited a “wilder” hypothesis as well — that a “proportion of the population might have pre-existing immunity to #SARSCoV2, potentially due to prior exposure to ‘common cold’ coronaviruses.”
Balloux said that might explain issues like cases where there is no transmission between spouses.
Earlier this month, an American study in the journal Cell suggested between 40 and 60 percent of the population could be immunized against COVID-19 without ever being exposed to it.
Researchers put this down to the action of protective cells, known as T lymphocytes, that had been activated by other coronaviruses responsible for colds.
But authors Alessandro Sette and Shane Crotty, of La Jolla Institute for Immunology, cautioned that the research did not suggest the epidemic was running out of steam.
“Clearly some individuals are more susceptible to the disease than others; after being infected some individuals have severe clinical symptoms and might even die, while others might show very little in terms of clinical symptoms,” they told AFP by email.
“Our study suggests that preexisting immunity might be one of the factors to be considered; but at this point is simply an hypothesis that needs to be addressed with further experiments.”

‘Jury out’

The World Health Organization has also expressed caution over the issue.
“There is certainly some evidence with regard to T cells, that if you have a previous coronavirus infection you may be able to mount a more rapid response to COVID-19,” said the WHO’s Michael Ryan at a press conference this week.
Michael Ryan, then WHO Director of Global Alert and Response of the World Health Organization (WHO), at a press conference in Geneva, Switzerland, May 2, 2009. (AP/KEYSTONE/Martial Trezzini)
“But there’s no empirical evidence that previous coronavirus infections protect you from infection with COVID-19. The jury is still very much out on that,” he added.
However, Ryan said it was an encouraging sign for the development of vaccines.
“It gives us hope that we are getting the kinds of immune responses that may be helpful to long-term protection,” he said.

New waves?

Another uncertainty is whether everyone is equally vulnerable to catching COVID-19.
A growing number of scientists think maybe not, raising questions over assumptions for what is known as herd immunity.
Gabriela Gomes, a researcher at the Liverpool School of Tropical Medicine, told AFP that it was wrong to assume that one person is as susceptible to the virus as another, or as exposed.
“We know little about the factors which underlie this individual variation. It could be cross-immunity with other coronaviruses, but it could also be other microbes, genetics, age, behavior, and most likely a combination of many factors,” she said.
In theory this could explain why early estimates of the proportion of individuals who have been infected by the new coronavirus have been lower than expected — at around 5 to 10 percent of the total population in several countries.
A doctor attends to patients in the intensive care unit in the COVID-19 ward of the Maria Pia Hospital in Turin, Italy, on April 7, 2020. (Marco Bertorello/AFP)
It could also mean a lower threshold for herd immunity — when a sufficient part of the population has caught the virus, starving it of new hosts to spread to and thereby stopping the epidemic.
This threshold, commonly accepted as around 60 to 70 percent of the population infected, is what Sweden hoped to achieve by deciding against a strict lockdown.
But Gomes said that mathematical models on herd immunity often “ignore individual variation.”
According to a study she co-authored, which has not yet been peer reviewed, the threshold might be reached when just 10 to 20 percent of the population has been infected.
Gomes said her research, which simulated the lifting of social distancing measures over the next six to 12 months, suggested that even if countries that had been severely affected are “closer to herd immunity,” they would still see more localized outbreaks.
There could also be “what may seem like a second wave in those countries that have been less affected so far.”
Illustrative: A medical worker pulls a patient from an ambulance in a hospital in Rennes, western France April 1, 2020. (AP/David Vincent)
At the Pitie-Salpetriere hospital in Paris, professor of emergency medicine Yonathan Freund has noticed a sharp drop in the number of infections among doctors compared with the start of the epidemic.
“This is pure speculation but it could mean that people have natural or acquired immunity,” he told AFP.
It is giving him confidence.
With infections staying low three weeks after France lifted its strict lockdown measures, he thinks that could mean “the second wave is not coming and probably will not happen” in the country.

(chloroquine)and W.H.O.because of Donald Trump,





Scientists have ‘serious doubts’ over study used to discredit malaria drugs






Scientists have ‘serious doubts’ over study used to discredit malaria drugs

Top researchers question methodology used in Lancet large-scale study, basis for WHO suspending clinical trials of the anti-viral drugs as potential COVID-19 treatments



Hydroxychloroquine pills. (AP/John Locher)
Hydroxychloroquine pills. (AP/John Locher)
PARIS (AFP) — Dozens of scientists have raised concerns over a large-scale study of hydroxychloroquine and chloroquine published in the Lancet that led to the World Health Organization suspending clinical trials of the anti-viral drugs as a potential treatment for COVID-19.
Hydroxychloroquine, normally used to treat arthritis, has become one of the most high profile drugs being tested for use against the new coronavirus.
This is partly because of comments by public figures including US President Donald Trump, who announced this month he was taking the drug as a preventative measure.
In research published in the Lancet on May 22, Mandeep Mehra of the Brigham and Women’s Hospital in the US looked at records from 96,000 patients in hundreds of hospitals between December and April and compared those who received treatment with a control group.
The study concluded that treatment with hydroxychloroquine and chloroquine, an anti-malarial, showed no benefit and even increased the likelihood of them dying in hospital.
Both drugs can produce potentially serious side effects, particularly heart arrhythmia.
The research published in the Lancet medical journal followed numerous smaller studies that suggested hydroxychloroquine is ineffective in treating COVID-19 and may even be more dangerous than doing nothing.

US President Donald Trump gestures as he leaves a meeting with restaurant industry executives about the coronavirus response, in the State Dining Room of the White House, Monday, May 18, 2020, in Washington. (AP Photo/Evan Vucci)
Within days the WHO temporarily suspended use of the drugs in its Solidarity Trial, which has seen hundreds of hospitals across several countries enroll patients to test possible treatments for COVID-19.
“This impact has led many researchers around the world to scrutinize in detail the publication in question,” said the open letter in response to the study, which was signed by a number of prominent scientists and published Thursday.
It added that this scrutiny raised “both methodological and data integrity concerns.”
One of the main concerns was a lack of information about the countries and hospitals that contributed to the data, which was provided by Chicago-based healthcare data analytics firm Surgisphere.
The authors also list “implausible” ratios of use of the drugs in some continents and discrepancies in the data for Australia, where they said there were more deaths recorded in the hospitals covered by the study than official figures for the entire country.
“Surgisphere (the data company) have since stated this was an error of classification of one hospital from Asia. This indicates the need for further error checking throughout the database,” the letter said.

Serious doubts

Among the signatories are clinicians, epidemiologists and other researchers from around the world, from Harvard to Imperial College London.
Francois Balloux of University College London, said he believed it was his “duty” to add his name to calls for answers to questions about the study and for greater transparency.
“I have serious doubts about the benefit of CQ/HCQ treatment for #COVID19 infection, and cannot wait for the whole drama to be over,” he said on Twitter, where #LancetGate was trending among science accounts.

Veterans Affairs Secretary Robert Wilkie holds up a U. Department of Veterans Affairs document titled Hydroxychloroquine Timeline and Utilization before a House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies hearing on Capitol Hill on May 28, 2020 in Washington, DC. (Andrew Harnik-Pool/Getty Images/AFP)
“Though, I believe ‘research integrity’ cannot be invoked only when a paper doesn’t support our preconceptions.”
The letter was also signed by French researcher Philippe Parola, a colleague of the Marseille-based professor Didier Raoult, whose work has been at the forefront of promoting hydroxychloroquine and has also been subject to criticisms over methodology.
The Lancet said it had received “several questions” over the study.
“We have referred these questions to the authors and they are working to address the issues that have been raised,” it said in a statement.
The coronavirus crisis has put enormous strain on the normally sedate system of scientific publication, with an avalanche of research and the process of peer review considerably accelerated.
A spokesman for the WHO said a comprehensive review of the drugs was expected to reach a conclusion in mid-June.
“Any decision on the hydroxychloroquine arm of the study must be based in a comprehensive analysis of the available evidence, particularly from concluded and ongoing randomised trials,” said spokesman Tarik Jasarevic.

Saturday, May 30, 2020