A clinical trial of remdesivir for treatment of coronavirus is expected to end in the next week or two with results to be available in the next two to three weeks. Remdesivir is an antiviral drug being tested to see the effectiveness against COVID-19.
Final results of the clinical trial are expected to be available by late May, but preliminary results may come in within one or two weeks. The first step will be analysis of the test, which will tell researchers if the drug performed better than the placebo.
Remdesivir was first tested as a possible treatment for another disease, Ebola. Researchers say it has shown promise for the treatment of the coronavirus in test tubes. Current information is conflicting as there are limitations on the knowledge available.
The current study is being conducted by the National Institutes of Health. It uses a placebo and is a double-blind trial with patients being chosen randomly. What this means is that all participants in the trial receive a treatment. It is either a dose of the drug or a placebo, but neither the patients or the doctors know who is getting remdesivir and who is getting the placebo.
The purpose for this kind of trial is to ensure the results are accurate and unbiased. They will be more believable for experts and the general public.
The target was to have 572 participants for the clinical trial, but researchers say they were over that goal. Participants came from all over the world. While the trial started with the University of Nebraska Medical Center, it has expanded to almost 70 other sites. There are sites in Germany, South Korea and many other places.
The hope is that the results will mean a big improvement for those who suffer from the virus. Researchers are hoping to see a shortening of the timeline for how long someone is sick as well as a reduction in the severity of symptoms. If the results don’t show what researchers hope for, they will remove it from the list of drugs and move onto another treatment for the next trial.
Gilead Sciences is the maker of the drug, and it has completed its own testing. The company released information from the results of 53 patients, which indicated they had shown improvement after being given remdesivir. The manufacturer is encouraged by the results, but the trial is inconclusive because there was no secondgroup to act as the control group.
The World Health Organization published results from another trial with the same drug. In this trial, patients had severe symptoms from the virus. The summary showed that the drug didn’t have significant results in the treatment of the illness. However, the results were published accidentally and critics say that the trial was
terminated earlier than planned because fewer people had enrolled. Gilead stated that the study was inconclusive. Regardless of past trials and results, many people are waiting anxiously for the results of the current trial.
Moderna Seeks Emergency Approval for COVID Vaccine
Moderna has completed phase 3 of a study on a COVID-19 vaccine. It was found to be over 94 percent effective for 30,000 participants. Based on the data from this study, Moderna plans to file what is known as an emergency use authorization or EUA with the Food and Drug Administration.
Of those in the vaccinated group, only 11 people tested positive for COVID-19 after taking the vaccine compared to 185 participants who were in the placebo group. Moderna also made the announcement that the vaccine prevented more serious cases of COVID-19. The 30 severe infections were found in the placebo group.
The FDA will review the data on safety and efficacy from Moderna at its VRBPAC meeting (Vaccines and Related Biological Products Advisory Committee), which is currently scheduled to be held on December 17.
According to a spokesperson with Moderna, the data confirms the ability of the vaccine to prevent COVID-19, especially severe cases. The goal of the vaccine is to prevent severe outbreaks of the disease as well as hospitalizations and death in those who contract the virus.
The efficacy of the vaccine was consistent in groups based on gender, age and ethnicity. The Modern trial included people who were over 65 years of age as well as participants from 42 communities, such as Hispanics, Asian Americans and African Americans. There were also participants who were multiracial.
No Concerns Over Safety
According to data from Moderna, participants tolerated the vaccine well with no serious concerns identified. The most common issues noted included fatigue, pain at the site of the injection, headaches, redness at the site, myalgia, and arthralgia. The frequency of the complaints increased in frequency and severity after the second dose of the vaccine were given. The only COVID-19 related death in the study came from the participants in the placebo group.
If the vaccine is approved by the FDA, Moderna has said it can have about 20 million doses ready to ship in the US by the end of 2020. It expects to manufacture between 500 million and 1 billion doses for around the world in 2021. Moderna is seeking approval from other organizations globally. It will be the second company to request an EUA with the FDA for a vaccine with Pfizer being the first.
As a vaccine reaches approval, the government will likely determine how it will be divided up. Some experts suggest the vaccine will go the states with the highest populations. It has also been suggested that a separate vaccine will be necessary for children and this first one approved will be for the adult population.
As more cities initiate greater restrictions and even lockdowns or stay-at-home orders, the need for a vaccine becomes more apparent. The fact that two such vaccines are close to being ready for use provides welcome news to the medical industry as well as the general population, especially as the holidays approach and flu season continues to be a concern.
Pfizer Vaccine for COVID Shows Positive Trial Results
Scientists working on what is known as BNT162b1 say the new vaccine shows promise for COVID-19. This vaccine is based on RNA gene technology, which has been deemed to be cutting edge.
Researchers claim that it created a strong immune response in those who participated in the study. The response continued to increase with the second dose and the amount given.
The research trail was led by Pfizer Inc. a pharmaceutical company. RNA is a geneticcode that triggers the immune system when it encounters a virus. Strategies for vaccines that utilize RNA are generally considered to be safe, which helps increase the speed of developing a vaccine.
The trial was a small one of only 45 participants. They were all adults who were determined to be healthy. They were between 18 and 55 years of age. Half of them were given a dose of the vaccine at either a low, medium or high dose. The other half were given a placebo.
Those that received the vaccine showed an immune response with a higher response for those who took the larger dose. A second booster continued to improvethe immune system.
It was also noted that participants tolerated the vaccine relatively well. They did notice soreness where the vaccine was injected. Participants reported headache, fatigue, fever and issues with sleeping which all cleared up within a week after being vaccinated.
Scientists look at this study as good news for battling the coronavirus. However, a phase 3 trial will be necessary, which will test the vaccine on a larger population to determine its true effectiveness as well as safety and preferred dosage. The study showed a higher number of antibodies for those participants even than what peoplewho are recovering from the virus have. However, the phase 3 trial will show how effective the vaccine will be in real life when a vaccinated person is in contact with the virus.
Numerous Vaccines in Trials
There are dozens of vaccines in various stages of the trials. Phase 1 and 2 are the early stages with testing on limited participants. Phase 3 is the final stage and features a much larger trial to determine safety. This trial can take several months, and the information must be presented before the US Food and Drug Administration will approve it for use on the general population.
Many drugs make it through the first two trials only to have poor results in phase 3. While this information for the Pfizer vaccine shows promise, the average patient won’t even know if it will be available for the general public for some time. Once it is approved, the manufacturer will have to develop large quantities of the vaccine to
provide to the population. Best estimates are still sometime in 2021 before there is a vaccine available to prevent COVID-19. Until then, other precautions are recommended to reduce the spread and fatalities for the coronavirus. Updates on this and other vaccines will be provided as the research team continues through theprocess.
Metformin as Potential Protector from COVID-19
Metformin is a common medication given to people diagnosed with type 2 diabetes. This group also happens to be considered high-risk for the coronavirus. Studies indicate the medication may help protect the vulnerable diabetics patients from some of the most severe symptoms of COVID-19 and reduce the number of fatalities.
COVID-19 Benefits Possible
A study was conducted by a doctor at the Hugh Kaul Precision Medicine Institute at the University of Alabama at Birmingham. The results have been published online but not reviewed by peers yet.
According to the researchers who reviewed information from over 600 patients, metformin was linked to almost 70 percent reduction in deaths for those who were diagnosed with diabetes and COVID-19. This information coincides with data from four other studies. That data was published in Diabetes and Metabolism.
Researchers suggest that metformin may have anti-inflammatory effects to go along with its ability to lower glucose levels. However, they do advise caution in reading too much into the data unless random controlled trials can be conducted.
According to experts, patients who take metformin tend to have better results in many situations. What hasn’t been determined if the medication can be called a miracle drug or if the people taking it are generally in better health and have no issues with use. They say there isn’t enough data to recommend metformin for use against COVID-19 at this time.
Possible Positive Results for the Study
In the Alabama study, 40 percent of the more than 600 patients were diagnosed with diabetes. Patients with diabetes were accountable for more than 60 percent of the deaths reported in this group. Independent predictors of death for the group included being diabetic, make and between the ages of 50 and 70. A total of 42 patients with diabetes died, and 18 of them had not used metformin. This means that 34 had used the drug, which led to an 11 percent mortality rate for metformin users. This percentage is comparable to the general population rather than the 23 percent rate for diabetics who didn’t take the drug.
Survival rate was determined after removing those with chronic kidney disease, heart failure and other contraindications. Critics of the study suggest that other factors can also impact the change in mortality rate. It can be assumed that control of glucose levels and body weight as well as a reduction in inflammation and other health improvements could also have a positive influence on the survival of the patient with COVID-19.
There are risks for diabetics who take metformin, particularly the increase in risk for lactic acidosis, which can lead to failure of multiple organs. It is unlikely that trials will be conducted to prove the benefits of metformin because pharmaceutical companies aren’t interested in studying a medication that is out of patent and no longer expensive. While these small studies may indicate potential benefits of taking metformin, it is unlikely to be substantiated with larger trials. Patients should only take the medication if it is effective for their condition, according to experts.
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