National health institutes The American is organizing clinical trials to verify the efficacy of remdisfer in treating Covid-19 disease, and an American recovery after taking the drug.
On January 19th, a 35-year-old American went to a clinic. He had a cough and a high fever. He had just returned from a visit to his family in Wuhan, China, when he saw the CDC warning in United States of America (CDC)- About the spread of Corona virus emerging (Covid-19), to decide to seek medical help, and thus ended up in that clinic, awaiting the unknown.
The next day, this thirties became the first status Confirmed infection with the virus in the United States. The patient was isolated in a hospital with observation of his condition, and various drugs were tried to reduce the severity of symptoms, but after 5 days he suffered from pneumonia as well as the persistence of fever, and when his condition worsened, the therapists thought of injecting him with an experimental antiviral drug called “remdisfer”, as his condition started To improve until fully recovered.
Scientists all over the world are now working hard to identify this virus and try to find effective treatments for it. However, until now there is no specific drug licensed by the U.S. Food and Drug Administration (FDA). To treat an emerging coronavirus infection, and most of the cases that have already recovered, she had taken symptoms-relieving medications: pain relievers, and cough remedies.
A ray of hope
In the not-too-distant past, when SARS and MERS spread, patients were treated with a set of FDA-licensed antivirals for use against similar off-label antivirals that included drugs such as lopinavir, ritonavir, and interferon beta , Along with some immune stimulants, but the results were not at the desired level In a recent study, published in the journal Nature Communications, researchers compared the use of this mixture with the use of Remdesivir in the treatment of Mers virus in laboratory cultured cells as well as in mice. The results showed that the preventive and curative use of the drug led to improved lung function and reduced vulnerability to the virus, and the drug helped the “macaques” to treat and prevent some viruses such as Ebola.
According to the results of another study issued by the US National Institutes of Health (NIH), remedies have proven effective in preventing SARS and MERS diseases in a particular species of monkeys, as well as significantly improving the response of sick monkeys. The latter is closely related to the virus that causes Covid-19, which is part of the coronavirus family.
Khalil – Professor of Immunology and Microbiology, Faculty of Medicine at Ain Shams University – said : “Remedieser works to inhibit the replication of the virus inside the host’s cell by reducing the production of RNA, and it can succeed in eliminating the virus.” According to the results of the study.
But some researchers believe that it is too early to judge the effectiveness of remediffer on humans, and they consider the case of the American patient “exceptional”, as it was decided to treat remedisfer due to the aggravation of the condition, and the matter was loaded with risks. Hussein – a researcher in virology, who works for the company “Microbiotics” specializing in the production and development of antimicrobial drugs – agrees with what “Khalil” went, saying to “for information”: The drug has a good opportunity, as its results were effective in The experiments were conducted on cells planted in the laboratory, but he stresses that “we will have to wait until proven effective in treating animals and then humans through clinical trials.”
Experiences on volunteers
On February 25th, NIH announced the start of randomized clinical trials to investigate the safety and efficacy of the use of experimental drug Remedsifer in patients (Covid 19). Such studies do not take place without a patient volunteering to try the treatment. The first person who decided to volunteer for these experiments was an American who had returned to his homeland after being quarantined on board the Diamond Princess ship that docked in Yokohama, Japan. According to Anthony S. Fossey – Director of the National Institute of Allergy and Infectious Diseases (NIAID) Corona Virus Team in the United States – in a report released by NIH, those studies are conducted in a system called Double Blind where placebo is given to some of the patients involved in the experiment, who are randomly selected And, the actual treatment is given to another group of participants.
As Fossey reported, this type of experiment is the “gold standard” for determining whether experimental treatment can benefit patients. Results are compared by comparison between the two groups after two weeks, on a seven-point scale, ranging from complete recovery to death.
All participants in the experiment are examined before they start to ensure their suitability, as participation is limited to confirmed cases of HIV infection, while people with mild cold-like symptoms are excluded. It is worth noting that there are several clinical trials of Remsdevir currently underway in China. Hussein explains that the remediscovery opportunity is strong, and according to published studies so far, “its results appear promising”, but it may not be the best method of treatment offered, as high efficacy has not been proven in clinical trials for Ebola, and all scenarios are still on the table, but what Its distinction is the mechanism of its action that makes its effect widespread.
More than 80 treatment experiences
Alongside Remediesvir, HIV / AIDS drugs, stem cells and some traditional Chinese remedies are competing to prove their effectiveness in treatment, according to the journal. Nature There are more than 80 treatment trials launched to search for a cure for the virus. Somaya Swaminathan – Senior Scientist at the World Health Organization: The organization is working to evaluate many Chinese experiments, and is working to develop a plan for a protocol of clinical trials, as well as working with Chinese scientists to develop strict standards from the beginning. For example, the stages of improvement or worsening of patients’ condition should be measured in the same way, regardless of the type of treatment being tested. It is noteworthy that two of the drugs used in these experiments are drugs to treat AIDS, and work to stop some of the enzymes that the virus needs in order to double, and it has shown success in the improvement of laboratory animals infected with SARS and MERS viruses.
What about vaccines?
On the other hand, vaccines help the immune system to identify some features of the virus, thereby developing antibodies to fight it if it is infected. But it is not that easy: viruses that infect different types of families – such as corona viruses – are more developed than others and change their shape constantly, making it easier to escape and hide them from the immune system.
Basil Assaf, a comparative pathologist, said : “The stages of development of any vaccine need to first design the vaccine, then test it on laboratory animals in studies of concept evaluation (PoC), and if the results are positive, the researchers move to tests.” Safety to ensure that the vaccine is safe and does not include serious side effects, and that comes before the transition to clinical trials in humans. “Assaf” states that these tests take very long, often years, but in cases of rapid need to develop a vaccine that can accelerate these Steps through specific laws that are regulated by the bodies Official drug.
In the case of the (Covid 19) virus, there is an urgent need to develop an anti-virus vaccine that is very rapid if compared to other less prevalent viruses, but a balance must be struck between the need for rapid production and a safety factor. At best, it is possible to conduct an accelerated study to develop the vaccine in critical cases, so that trials take a shorter time than usual in normal conditions, as is the case in the Fast Track laws of the US Food and Drug Administration.
“Assaf” explains that clinical trials in humans may begin in people who are at high risk of contracting the disease. The first stage takes place on a small number of people to ensure the safety of these vaccines and the absence of serious side effects, and when the trials give positive results, they are tested on a larger number.
Assaf adds that the FDA and the European Medicines Agency (EMA) are keen to prioritize the safety and security factor in the experiment for any drug or vaccine under development, especially if the adjuvants used with the vaccine are not commonly used substances in similar vaccines. And materials Help They are substances added to vaccines to help stimulate the immune system and improve its response.
Is it worrying?
While the world is racing to obtain a cure or vaccine for the virus that causes Coffid-19, some researchers hope that its spread will decrease as the weather changes, as stated by Ahmed Maher Ramadan – Professor of Public Health and Preventive and Social Medicine at the Faculty of Medicine, University of Alexandria – in his talk to “for information” Viruses do not like droughts and high temperatures, which is why the spread of the virus is likely to decrease in the coming months.
Despite the increasing number of people infected with the virus – as of March 18 – in 170 countries, the death rate from the disease is much lower than the rate Other viruses from the same family. The death rate from the Mers virus was 34%, and the result from the SARS virus is 9,6%, while the death rate from (Covid 19) is estimated at the date of publishing the report at 3.4% so far.
influenza type B kills twice a year the number of deaths resulting from the emerging corona virus, and the death rate from the latter increases significantly in the elderly, reaching 8% in the age group between 70 and 79 years, and up to 14.8% Among people over 80 years old, this is due to the weakening immunity of the elderly and their suffering usually from other diseases, as well as to taking drugs that reduce immunity. Ramadan calls for preventive measures to be taken to combat infection, which include washing hands well with soap and water, maintaining personal hygiene and cleaning the surfaces of the things we deal with, and avoiding touching the face as much as possible, as well as avoiding kissing and shaking hands with others.