The alarming releases by The Centers for Disease Control and Prevention (CDC) continue to report the racial and ethnic disparities in illness and death in COVID-19. It is widely known that underlying medical conditions increasing this risk for severe illness from COVID-19 may be more common among people from racial and ethnic minority groups. And the common underlying conditions among those who require mechanical ventilation or died included diabetes, high blood pressure, obesity, chronic kidney disease on dialysis, and congestive heart failure. But through a new FDA-approved clinical trial, this first of its kind study is specific in developing a cure to help African Americans with the coronavirus. Nitric Oxide Innovations (NOi), founded and led by Dr. Nathan S. Bryan, established this study to prevent the rapid progression of the virus, improve recovery and survival of African Americans, or anyone who is symptomatic. Among the adept and renowned medical team supporting Dr. Bryan’s study is Dr. Richard E Harris II. Not only as a doctor, but as an African American seeing how the coronavirus impacts our community, Dr. Harris recognizes this clinical trial’s focus is imperative for a cure to help combat the disease, reducing the number of infections among African Americans.
NOi is positioned to advance patented nitric oxide (NO) science into new and innovative therapies for human disease across different markets. NO is considered one of the most important molecules naturally produced by the human body. Loss of NO is one of the most important contributors to aging and age-related disease. It is a cell-signaling molecule responsible for many important and essential cellular functions including acting as a vasodilator and regulating oxygen delivery. Our endothelial cells, the cells that line the interior surface of our blood vessels, are the main source of NO production. Endothelial NO production is what maintains the integrity of our endothelium. Loss of NO is referred to as endothelial dysfunction. Every major chronic disease is characterized by endothelial dysfunction. NO is also important in our immune system. NO produced by macrophages and neutrophils is responsible for killing invading pathogens such as bacteria and viruses.
NO is vital for the maintenance and regulation of blood flow. It’s also important for our immune system. “The older you get, the less nitric oxide you make, and once you hit 40, NO levels start to rapidly decrease. But also certain diseases, like cardiovascular disease and diabetes, are known to decrease NO, as well as lack of exercise and certain dietary decisions. So if you’re eating a lot of processed foods or not enough fruits and vegetables, you can decrease NO. And we also know that there are some genetic abnormalities and genetic differences that African Americans have that contribute to lower NO levels,” said Dr. Harris. This contributes to the reasoning as to why we are seeing the health disparities with COVID-19, where the African-American population is being hit at a much higher rate with the disease. “NOi’s clinical trial is targeting African Americans in the 50 to 85 age range with pre-existing conditions. This is the highest risk group and the group that we’re most likely to see in the hospital, being most at risk for severe COVID infection and the worst outcomes. So this is the group that we really want to focus on keeping out of the hospital, because once they are admitted to the hospital, the stays for this group are very long, and the risk of severe complications is very high. We’re still scratching the surface on the long-term implications of COVID,” Dr. Harris said
Dr. Bryan has earned the support of Dr. Harris and the medical community in this study as he is a global leader in molecular medicine and nitric oxide biochemistry. “We recognized early on that our patented NO technology would have a very important role in the treatment and protection from the coronavirus. We filed for our investigational new drug application (IND) through the Food and Drug Administration (FDA) as part of the Coronavirus Treatment Acceleration Program back in June 2020 and received clearance in July. The FDA immediately recognized how our study design and technology could potentially impact the African American community, allowing us to move forward with our study,” said Dr. Bryan.
Q&A with Dr. Bryan and Nitric Oxide Innovations:
Please educate our readers on NOviricid, created by Nitric Oxide Innovations, the first oral NO-generating drug to be specifically tested to treat African Americans diagnosed with COVID-19. NO is a gas that is normally produced inside the lining of the blood vessels. The older we get, the less NO we produce and the loss of NO responsible for symptoms and comorbidities such as high blood pressure, heart disease, kidney disease, diabetes, pulmonary disorders, the exact same comorbidities that put people at increased risk for contracting COVID-19. African Americans suffer from NO deficiency more than any other population, and that explains their increased risk of COVID infection, rate of hospitalization, and higher death rate. NOviricid is a NO generating tablet that is designed to restore and replete NO in the African American patient. The amount of NO produced by NOviricid inhibits coronavirus replication, preventing its rapid spread throughout the body and also allows for better circulation to mobilize the immune system to fight the virus. NOviricid is natural and is designed to restore the natural production of NO, making it very safe.
Late last year your company aimed to enroll 840 African American COVID-19 patients, each within 72 hours of them testing positive for the infection. Did you meet that goal/exceed it? We are currently in the midst of our 840 patient trial. We need more patients to know about our study and to enroll so we can quickly fulfill enrollment and get the data to apply for approval of our drug. We feel very confident that this drug can save the lives of millions of African Americans. One of the benefits of enrolling in this study is that we provide you with a pulse oximeter to measure your blood oxygen levels, a blood pressure device, and a thermometer to monitor your progress. We also have someone call you and check on you several times per week during the 30-day study. We understand that being diagnosed with COVID-19 can be scary so we continually check on you to monitor your health and progression of symptoms.
According to the CDC, African Americans experience a 2.8 times higher SARS-CoV-2 infection rate, a 4.7 times higher hospitalization rate, and 2.1 times higher death rate than Caucasians. Is this the main reasoning behind your company’s study targeting the African American community? Yes, indeed. The medical and scientific community have known for decades that African Americans have a higher incidence of all major diseases, including cardiovascular disease, diabetes, kidney disease, cancer, pulmonary disease, etc. However, no one has done anything about this health disparity. Our objective is to take the most vulnerable patients, which is the African American between ages 50-85 with at least one underlying comorbidity recently diagnosed with COVID to show how effective our drug can be in this population. If we can show safety and efficacy in this population, it will work very nicely in the general population. Our aim is to save the lives of the African American community who are needlessly dying from COVID-19. We have the science and understanding of what causes the health disparities, and we have the technology to treat and make the community healthier. We can no longer ignore the health disparities of African Americans when we have the technology to specifically address this.
Where is NOi with this study? Are there any results you can report or provide to our readers? We are only a few months into the study, and we are not allowed to review any data until the study is complete. However, our clinical trial coordinators who call on the patients reveal that many patients feel better and are staying out of the hospital. This is very encouraging. We have several clinical sites set up across the United States. We have a clinical site in Houston at the Texas Center for Lifestyle Medicine (5252 Hollister, St. #201, Houston, TX 77040, (713) 690-1991). We also have clinical sites in Chicago, Los Angeles, Jackson, MS, Augusta, GA, and Lakeland, FL. African Americans in the target group of 50-85 with an underlying condition and recently diagnosed with COVID-19, please visit www.aacovidstudy.com and see if you qualify. You can also contact the Texas Center for Lifestyle Medicine at the number above.
Though there may be some side effects (normal signs that the body is building protection) after taking the vaccine, is there anything else people should be aware of before taking the current COVID-19 vaccines (produced by Pfizer-BioNTech and Moderna) available in the U.S.? NOviricid is considered a therapeutic, not a vaccine. We have over 10 years of safety data on our NO drug technology. This new class of COVID vaccines using messenger RNA does not have a history of safety in humans. There is very little safety information on the COVID vaccines, and so we just do not know how patients will react to the vaccine. We do know how patients respond to NOviricid, and there are no side effects. I encourage every person to do their own research and consider the available data on both therapeutics and vaccines. There is very little safety information on the vaccines. I wrote about this just a few months ago. Visit the link at https://drnathansbryan.com/vaccines-vs-therapeutics-understanding-the-differences/ to read more.
What are your thoughts/opinions on news stories we see when there are reports of people becoming ill/dying as a result of a COVID-19 vaccine? This is very concerning. The new COVID vaccines are not like vaccines from the past. This is a brand new concept and technology that has not been adequately tested in humans. There are always people that have an adverse reaction to vaccines, including the flu vaccine. I think it is important to always consider the risk benefit of taking a vaccine or therapy. We know from the seasonal flu vaccine that at best it may protect 40% of the population from the flu. The best available data on COVID is that it may protect 65% of the population, assuming there are no new variants or strains of the coronavirus. We already know there are new variants that the vaccine may not protect against, and there is new data showing that COVID is actually learning how to resist vaccines. This drastically reduces the benefit of getting the vaccine while we really don’t know what the risks are and if patients will become ill or die from the vaccine. In this case, the risks far outweigh any benefits. In my professional opinion, the vaccines were rushed to market without sufficient short-term and long-term safety data. We need more safety data before we begin a mass vaccination effort.
Is there anything else you would like our readers to know about NOi or NOviricid? NOviricid is unlike any other drug technology. Most drugs act as inhibitors of specific biochemical reactions in the body. When you inhibit a normal biochemical process, there are always side effects. NOviricid is not an inhibitor, but actually a NO donor that repairs and restores normal NO production in the human body. We call this applied physiology. Our strategy of drug development is to understand the mechanism of disease to the extent we can develop safe and effective therapeutics to address the underlying cause of disease. Everything we have learned about COVID-19 points to a deficiency in NO production that explains the increased risk of infection, increased rate of hospitalization, and increased death in the African American community. NOviricid specifically addresses the root cause of COVID disease. NOviricid is the first in our line of potential drug candidates for a host of human diseases. We will continue to be the market leader in safe and effective NO drug technologies.
With this history-making medical treatment and new approach to COVID-19, the efforts of Dr. Harris and Dr. Bryan could not be possible without some of the most experienced and top medical professionals in the world.
The members of the medical team include:
- Lane Rolling, M.D.
- Michael A. McGee, MD, MPH, FACEP.
- Dr. Byron Dean, DO
- Dr. Cheng Ruan M.D.
*Full bios are on the website.
African Americans experiencing a 2.8 times higher SARS-CoV-2 infection rate, a 4.7 times higher hospitalization rate, and 2.1 times higher death rate than Caucasians is the reasoning behind NOi’s focus on our community. A limited breakthrough study, NOi is predicted to impact and improve the health of African Americans during the pandemic and in the future.
This clinical trial as the first of its kind is specifically addressing the health disparities in people of color, one of the most affected, high-risk populations of the virus. And with trial participation supporting the progress of medicine and treatment, this can go beyond COVID-19, with a worldly impact to the medical world’s approach in treating our community effectively.
For more information about this study and to see if you qualify to participate, please visit www.aacovidstudy.com. To read more on Nitric Oxide Innovations, LLC, visit www.nitricoxideinnovations.com.
Source:
Centers for Disease Control and Prevention
