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Merck and Ridgeback’s oral antiviral medication, molnupiravir is the first COVID-19 medicine to receive global authorization

 

Molnupiravir is the world’s first antiviral medication in the oral form. This medication has been approved for treating COVID-19 patients who have developed mild to moderate symptoms. This medication is safe for use only in adults who have been tested positive for COVID-19 and who have atleast one underlying disorder that poses as a risk factor. Molnupiravir has been jointly developed by Merck and Ridgeback Biotherapeutics. In the United Kingdom, the medication has been approved for use by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). Merck has now requested United States Food and Drug Administration (FDA) to authorize the use of molnupiravir in the US.

Merck would also be filing regulatory applications in the European Union. Following the authorization, Merck received another feather in its cap. The company has always been a pioneer in developing breakthrough medications that control the global pandemic. The life-saving medication will not only save the life of COVID-19 patients, but also be an effective oral therapeutic for lung disorders. This is a major boost to COVID-19 treatment, which included only vaccines as a preventive measure.

The phase 3 clinical trial of molnupiravir was known as MOVe-OUT clinical trial. The positive results of this clinical trial compelled the authorities to give a positive feedback. In this trial, 800 mg of molnupiravir was administered orally to COVID-19 patients who are neither hospitalized nor vaccinated. The medication was given twice daily after laboratory tests confirmed that their symptoms were mild to moderate. These patients had at least one risk factor, such as diabetes and heart disease.

The collaboration between patients and physicians seemed to be successful in this clinical trial. This is an extraordinary effort in controlling the global pandemic. The efforts of all brave volunteers of this clinical trial must be applauded. Merck is now working hard to gain licenses from other global regulatory authorities in order to broaden the access to this wonder drug globally. Let’s understand what is molupiravir in biological terms. Well, it is a potent form of a ribonucleoside, preventing SARS-CoV-2 from replicating and proliferating. This virus is the leading cause of COVID-19.

The efficacy of molnupiravir is now being evaluated in the prophylaxis MOVe-AHEAD study. This phase 3 study would be performed in a randomized, double-blind manner; however, the control would be a placebo and the clinical trial would be in a multicentre setting. The goal is to evaluate whether molnupiravir is effective in controlling and preventing COVID-19 in household patients. The clinical trial patients were not vaccinated for SARS-CoV-2. Moreover, they had at least one underlying disease that could complicate their case of COVID-19.

 

 

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In hospitalized COVID-19 patients, the viral load was significantly reduced by ronapreve drug: clinical trial phase III results of Roche Diagnostics

 

Roche is a leading biopharmaceutical company that has spearheaded the fight against COVID-19 pandemic. Its phase II/III clinical trial showed positive results when the combination of casirivimab and imdevimab drugs were administered to hospitalized patients of COVID-19. Ronapreve is the combined medication of casirivimab and imdevimab drugs.

The testing of this medication was successful as it significantly decreased the viral load of COVID-19 patients who consumed it for seven days. These patients were seronegative, that is, they did not exhibit any antibody response. Moreover, they were treated with low-flow supplemental oxygen.

The pandemic of COVID-19 has been devastating, accounting for more than 4.7 million deaths across the world. Most hospitalized patients succumbed to COVID-19 disease. Although vaccines are quite effective in preventing hospitalization of patients, a significant number of patients still are not vaccinated and their infection escalates, requiring hospitalization. The growing burden of healthcare systems has been eased out on the knowing the results of the latest clinical trial: ronapreve is quite effective in reducing the viral load of hospitalized COVID-19 patients.

In the phase III clinical trial, it was found that Ronapreve medication is safe and effective on COVID-19 patients who were hospitalized and non-hospitalized. Moreover, it is also effective as a preventive medication. The clinical trial of Ronapreve was double-blinded and randomized. The effect of placebo was also measured in this clinical trial.

Among the 1197 patients included in the trial, 530 patients did not receive supplemental oxygen whereas the remaining 667 patients received oxygen at a low-flow rate. Besides ronapreve medication, all the confirmed cases of COVID-19 received standard care in the form of corticosteroids (75%) and remdesivir (55%).

The companies Roche and Regeneron have jointly synthesized and tested the drug ronapreve, which is a combined form of two monoclonal antibodies, namely, casirivimab and imdevimab. The drug design of ronapreve is such that it blocks SARS-CoV-2, that is, the pathogenic virus that leads to the development of COVID-19.

 

 

 

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Healthcare workers do not develop COVID-19 symptoms after receiving mRNA vaccine

 

In clinical practice, healthcare workers may develop symptomatic COVID-19, so they are advised to take mRNA COVID vaccines as a recent study of researchers have found them to be very effective in preventing COVID-19. The study was published in the prestigious New England Journal of Medicine.  In this study, the chances of developing symptoms of COVID-19 decreased as much as 89% in healthcare workers who received two doses of Pfizer-BioNTech vaccine. The Moderna vaccine was even more effective as it reduced the risk of developing COVID-19 by as much as 96%.

The researchers found that the vaccines were effective even in people above 50 years of age. Moreover, certain ethnic groups or racial groups who were more prone to developing COVID-19 were the ones who benefitted the most from vaccination drives. Healthcare workers who were exposed to COVID-19 patients also got immunity with vaccine. Finally, patients with underlying medical conditions benefitted from vaccines but the efficacy of the vaccine was lower in patients with compromised immunity.

The study was conducted by researchers working at the Carver College of Medicine, which is affiliated to the University of Iowa in the US. In this study, 5000 healthcare workers were evaluated: 1482 healthcare workers were found to be COVID-19 positive because they were having symptomatic illness. Moreover, 3449 healthcare workers had symptoms of COVID-19 but they were tested as negative. As many as 33 academic medical centers from the US participated in this study. The participants had to complete a survey questionnaire and provide information about their demographics, type of job, risk factors, severe disease associated with COVID-19, and the status of their vaccination.

Although all the subjects received two doses of mRNA vaccines, the risk of developing COVID-19 was reduced by 95% in Afro American subjects. On the other hand, the risk of COVID-19 declined by about 89% in Asian and Hispanic subjects and by about 94% in American Indian people. In subjects whose immunity was compromised with underlying disease, the risk of developing COVID-19 decreased by only 39%, regardless of whether they received a single dose or two doses of  mRNA vaccine. Among pregnant women who received mRNA vaccine, the risk of developing COVID-19 decreased by about 77%. Even a single dose of the vaccine was quite effective in reducing the risk of COVID-19 as compared to those unvaccinated people. The study was conducted from December 2020 to May 2021.

 

 

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Researchers discover the mechanism of drug targets for COVID-19

 

In the latest issue of the journal Molecular Cell, a team of researchers from McGill University have uncovered the underlying mechanism through which drug targets control the progression of several inflammatory diseases, such as cancer, rheumatoid arthritis, and COVID1-9. These researchers have deciphered how cell receptors function within a patient’s body.

Whenever pathogens such as viruses attack human body, the body elicits defense mechanism. The complement system of cell receptors plays a pivotal role in eliciting a defensive response towards antagonistic pathogens. The pathogens that enter our body can either be bacteria or viruses. In the presence of a virulent attack, the complement system activates two membrane receptors, namely, C5aR1 and C5aR2. These were the findings of the international team of researchers.

Although the complement system should be activated in the presence of pathogens, there can be instances where the activation is excessive and uncontrolled. This is a dangerous situation as it can cause inflammation and even life-threatening complications in patients with COVID-19. Latest genetic technologies such as CRISPR are cutting-edge tools to unravel the exact functioning of C5Ar2 membrane receptor of cells, which were also observed through cryogenic electronic microscope. With this information, researchers identified therapeutic drug targets of COVID-19.

According to a noted medical professor, COVID-19 cases can be treated by blocking the activated expression of C5aR1 membrane receptor of cells. Moreover, Avdoralimab is a clinically tested drug that showed high efficacy in tackling severe pneumonia of COVID-19 patients. On the other hand, our current team of researchers were focused on targeting the expression of C5Ar2. For this purpose, they designed novel drug molecules that effectively clung to the receptor C5Ar2, blocking its activated expression and suppressing the related inflammation.

In molecular biology, it is a well-known fact that receptors surround human body cells. These receptors serve as drug targets, that is, the active ingredient of the drug exerts its pharmacological action on receptors, which also function as messengers. In other words, signals are transmitted and received by receptors of cells, which govern various physiological mechanisms in the human body. With the help of latest genetic technologies, our researchers could uncover important information pertaining to novel drug discovery and cell signaling processes.

 

 

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According to Cleveland Clinic, severe COVID-19 disease can be effectively controlled by steroid nasal sprays

 

Recently, a study conducted by Cleveland Clinic was published in the Journal of Allergy and Clinical Immunology. According to this study, severe COVID-19 infection was less likely to develop in subjects who used steroidal nasal sprays on a regular basis. These sprays were so effective that they reduced the chances of hospitalization and mortality by as much as 25%. Researchers at the Cleveland Clinic investigated 72,147 cases of COVID-19: all the patients were 18 years and above in terms of age. This is a very recent study that was conducted between April 1, 2020 and March 31, 2021.

The study cohort of patients included 12,608 hospitalized cases. Among them, as much as 2,935 cases were admitted to intensive care unit (ICU). Finally, the number of patients who died in hospital included 1,880. Interestingly, as much as 10, 187 patients were regularly using steroidal nasal sprays, which are nothing but corticosteroids administered through intranasal route. These patients used nasal sprays even before getting infected with COVID-19. Therefore, the chances of hospitalization declined by as much as 22% in these patients. Moreover, the need for ICU admission decreased by about 23% in these patients. Finally, the chances of dying in the hospital decreased by about 24%, as compared to patients who did not use steroidal nasal sprays.

These findings are quite encouraging to patients who regularly used intranasal corticosteroids. However, it does not mean that these corticosteroids are quite effective in treating and preventing COVID-19 disease. Yes, this seems contradictory but true. But several reports have endorsed the fact that in vitro use of intranasal corticosteroid would effective reduce the expression of ACE2, a protein receptor associated with SARS-CoV-2 virus. Thus, the virus would enter the cells and cause the spread of COVID-19. Nasal sprays contain corticosteroids, which belong to steroidal family of drugs. These nasal sprays are usually inhaled to control several nasal infections, such as stuffy nose, allergies, severe cold, etc.

Intranasal corticosteroids are either sold over the counter or with the help of prescription. However, researchers still do not know the exact mechanism through which these nasal sprays control COVID-19 infection. The findings of this study were coupled with the fact that the expression of ACE2 was highest in the mucosal lining of the nose. Based on this, researchers developed the following hypothesis: the viral load and the expression of ACE2 receptor can be suppressed in the nose with the use of intranasal corticosteroids, making them quite effective against severe COVID-19 infection. However, future studies must be conducted to validate the hypothesis.

 

 

 

 

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In severe cases of COVID-19, autoantibodies cause havoc and even death

 

It is a well-known fact that the pandemic of COVID-19 can be controlled only by boosting the production of antibodies in the immune system of patients. However, a recent article in Nature magazine reports otherwise. According to scientists at Yale University, the immune system of patients with severe COVID-19 is impaired significantly and boosting the production of antibodies cannot really control the illness.

Diseases like lupus and rheumatoid arthritis are autoimmune disorders, which are treated by boosting the production of autoantibodies. These antibodies interact and target damaged tissues associated with autoimmune diseases. In patients afflicted with COVID-19, autoantibodies target multiple organ systems that are otherwise healthy. This means that healthy tissues in the brain, liver, and gastrointestinal tract are attacked by autoantibodies. Moreover, they also target blood vessels and platelets in the bloodstream. This implies that the severity of COVID-19 is directly proportional to the number of detected autoantibodies.

Scientists at Yale University also found out that these autoantibodies attack many proteins in the immune system, that is, proteins that otherwise effectively fight infections are damaged by autoantibodies. Therefore, the situation is like a double-edged sword in patients with severe COVID-19 infection. In general, antibodies are effective in combating infection, but when COVID-19 infection is severe, patients develop autoantibodies. These autoantibodies attack multiple types of cells and tissues.

In most cases of COVID-19, the infection became severe and led to the production of autoantibodies, which are antibodies that caused extensive damage. However, it must be noted that in most severe cases of COVID-19, patients already had a pre-existing disease that caused the production of autoantibodies. The observation was done after testing mice with pre-existing autoimmune disorders and who had developed COVID-19 infection. Such mice had a large concentration of autoantibodies. Such kind of sickly mice were more likely to succumb to COVID-19 infection as there is no effective cure till date.

Autoantibodies are also called rogue antibodies and are believed to be existing for a long period of time in patients with pre-existing autoimmune disorders. When such patients contracted COVID-19 infection, they developed severe form of the disease that could not be tackled with existing medications and injections. The medical symptoms of COVID-19 became severe and long lasting in these patients. In other words, the virus became a legacy in the bodies of these patients. Therefore, all patients with autoimmune disorder should immediately be vaccinated to prevent more cases of severe COVID-19.

In patients with autoimmune disorder, autoantibodies are produced even at a mild stage of COVID-19 infection. The study was conducted by an esteemed team of scientists and physicians working at Yale University. In their clinical practice, they made concerted efforts to tackle COVID-19 infection: they screened blood samples of 194 patients with COVID-19 infection; the extent of severity was different in different patients. Nevertheless, autoantibodies were detected in all the blood samples of these patients.

Yale scientists developed a novel technology to detect the extent of damage caused by autoantibodies to proteins of the immune system. The technology was named Rapid Extracellular Antigen Profiling (REAP), and it explored the interaction of autoantibodies with approximately 3,000 proteins of the human body.

The scientists at Yale believe that the study’s findings may be used to develop novel strategies to combat or even prevent the damage caused by autoantibodies in patients with severe infection of COVID-19. Moreover, REAP technology is not just restricted to measuring the response of autoantibodies to COVID-19 infection.

The technology can be used to determine the damage caused by autoantibodies in patients with many types of autoimmune disorders and chronic diseases. These scientists are now exploring whether the technology can be used to determine the damage caused by autoantibodies in cancer patients and in patients with neurological disorders.

 

 

 

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Pfizer signs a cooperation deal with Gilead for remdesivir, a COVID 19 medication

 

Pfizer signed a cooperation deal with Gilead Sciences to produce and supply remdesivir, a promising drug used to treat COVID-19. According to this agreement, Pfizer shall provide production services at its McPherson, Kansas factory in the US. The company would be manufacturing and supplying the drug remdesivir for Gilead.

After signing the cooperation agreement, Pfizer became a promising company in the fight against COVID-19. The deal is aligned with the “innovation ecosystem” that commits to fight a battle against COVID-19 pandemic. The agreement has brought about a fruitful collaboration between small biotech companies and large pharmaceutical companies. Many government agencies associated with academia would be benefitted from this cooperation.

The COVID-19 pandemic has become a real menace, and a single company cannot really bring about an innovation and put an end to the COVID-19 menace. The deal between Pfizer and Gilead would be good enough to bring about an innovative ecosystem, which will deliver effective medical solutions. Both companies would be working together to manufacture vaccines, sterile injections, and biologics.