Showing posts with label covid-19. Show all posts
Showing posts with label covid-19. Show all posts

Wednesday, 20 May 2020

Chinese Drug Laboratory Stops Coronavirus


A Chinese drug laboratory has been developing a drug it believes has the power to bring the coronavirus pandemic to a halt.

The outbreak first emerged in China late last year before spreading across the world, prompting an international race to find treatments and vaccines.

A drug being tested by scientists at China's prestigious Peking University could not only shorten the recovery time for those infected, but even offer short-term immunity from the virus, researchers say.

Sunney Xie, director of the university's Beijing Advanced Innovation Center for Genomics, told AFP that the drug has been successful at the animal testing stage.

"When we injected neutralising antibodies into infected mice, after five days the viral load was reduced by a factor of 2,500," said Xie.

"That means this potential drug has (a) therapeutic effect."

The drug uses neutralising antibodies -- produced by the human immune system to prevent the virus infecting cells -- which Xie's team isolated from the blood of 60 recovered patients.

A study on the team's research, published Sunday in the scientific journal Cell, suggests that using the antibodies provides a potential "cure" for the disease and shortens recovery time.

Xie said his team had been working "day and night" searching for the antibody.

"Our expertise is single-cell genomics rather than immunology or virology. When we realised that the single-cell genomic approach can effectively find the neutralising antibody we were thrilled."

He said he hopes that the drug will be ready for use later this year and in time for any potential winter outbreak of the virus, which has infected 4.8 million people around the world and killed more than 315,000.

"Planning for the clinical trial is underway," said Xie, adding it will be carried out in Australia and other countries since cases have dwindled in China, offering fewer human guinea pigs for testing.

"The hope is these neutralising antibodies can become a specialised drug that would stop the pandemic," he said.

China already has five potential coronavirus vaccines at the human trial stage, a health official said last week.

But the World Health Organization has warned that developing a vaccine could take 12 to 18 months.

Scientists have also pointed to the potential benefits of plasma -- a blood fluid -- from recovered individuals who have developed antibodies to the virus enabling the body's defences to attack it.

More than 700 patients have received plasma therapy in China, a process which authorities said showed "very good therapeutic effects".

"However, it (plasma) is limited in supply," Xie said, noting that the 14 neutralising antibodies used in their drug could be put into mass production quickly.

- Prevention and cure -

Using antibodies in drug treatments is not a new approach, and it has been successful in treating several other viruses such as HIV, Ebola and Middle East Respiratory Syndrome (MERS).

Xie said his researchers had "an early start" since the outbreak started in China before spreading to other countries.

Ebola drug Remdesivir was considered a hopeful early treatment for COVID-19 -- clinical trials in the US showed it shortened the recovery time in some patients by a third -- but the difference in mortality rate was not significant.

The new drug could even offer short-term protection against the virus.

The study showed that if the neutralising antibody was injected before the mice were infected with the virus, the mice stayed free of infection and no virus was detected.

This may offer temporary protection for medical workers for a few weeks, which Xie said they are hoping to "extend to a few months".

More than 100 vaccines for COVID-19 are in the works globally, but as the process of vaccine development is more demanding, Xie is hoping that the new drug could be a faster and more efficient way to stop the global march of the coronavirus.

"We would be able to stop the pandemic with an effective drug, even without a vaccine," he said.

Saturday, 2 May 2020

Remdesivir gains FDA Approval


The Food and Drug Administration has granted remdesivir emergency use authorization to treat the most severely ill COVID-19 patients.

The FDA action specifies the drug may be used for both adults and children with suspected or confirmed COVID-19 diagnoses who are severely ill with low blood oxygen levels or who may be on a ventilator.


"Given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug's use," the FDA wrote in a press release.

The announcement came Friday during an Oval Office meeting between President Donald Trump, HHS Secretary Alex Azar, FDA commissioner Dr. Stephen Hahn, as well as the CEO of Gilead Sciences, the company that developed remdesivir.

The FDA's decision expands doctors' ability to use remdesivir on the most severe cases. Previously, physicians were limited to trying the drug in clinical trials or in what's called compassionate use for patients who have no other treatment options.


Remdesivir company CEO: It’s ‘not a cure, but a very significant treatment’
The FDA's emergency use authorization increases access by allowing any doctor "to prescribe remdesivir for their patients who are hospitalized with COVID-19," Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, explained.

However, that does not mean the drug should be used for all hospitalized patients.

"Ongoing clinical trials will define which patients will best benefit from remdesivir treatment," Schaffner wrote in an email.

The FDA wrote that possible side effects include, "increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering."

The emergency use authorization is not the same as FDA approval, Dr. Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research tweeted Friday.

"We need final data from clinical trials included in an FDA application to determine whether remdesivir is safe and effective in treating or preventing COVID-19," Woodcock wrote.

Earlier this week, Dr. Anthony Fauci announced early results from a large study of remdesivir, saying the data show a "clear-cut, significant, positive effect in diminishing the time to recovery."

Hospitalized patients who received remdesivir in the study were able to be discharged within 11 days, on average, compared to 15 days among patients who received a placebo. It is not considered a cure.

Source :https://www.nbcnewscom/health/health-news/fda-grants-remdesivir-emergency-use-authorization-covid-19-n1197576

Monday, 27 April 2020

Clinical Trials of drugs and vaccines against Covid-19.



Apeiron Biologics has secured approvals from regulatory agencies in Austria, Germany and Denmark to conduct a Phase II clinical trial of APN01 for the treatment of Covid-19.

APN01 is the recombinant version of the human angiotensin-converting enzyme 2 (rhACE2) with a dual mechanism of action.

The drug candidate is designed to imitate human ACE2 used by the virus to enter host cells. It is believed to possess the potential to inhibit the Covid-19 infection and reduce lung injury.

The inhibition is expected to be possible as the virus attaches to soluble ACE2/APN01, rather than ACE2 on the cell surface, making the virus incapable of further infecting the cells.

In addition, the drug candidate mitigates the harmful inflammatory reactions in the lungs and protects against acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).

Apeiron Biologics CEO Peter Llewellyn-Davies said: "Based on its unique dual mechanism of action, APN01 has the potential to be the first drug approved to treat Covid-19 that specifically targets the new SARS-CoV-2 virus.

"We look forward to dosing the first patient in our Phase II trial shortly,with the goal of providing a safe and effective treatment option for severely infected COVID-19 patients in urgent need of help."