COVID-19 Clinical Research Archives - AZ Clinical Trials

COVID-19, Evusheld, and Liver Patients

June 20, 2022 No Comments

Evusheld is a long-acting investigational protective measure against COVID-19, featuring a combination of two monoclonal antibodies. The FDA recently gave its approval under an emergency use authorization (EUA). Evusheld is a game-changer for liver patients and other individuals with a compromised immune system. What is Evusheld, and Who Can Use It? Evusheld is a combination of two long-acting monoclonal antibodies: Tixagevimab Cilgavimab Scientists create monoclonal antibodies in a laboratory to act as your own antibodies. Their purpose is to restore, modify, and enhance the body’s immune system’s attack on harmful cells or contagions like COVID-19. Evusheld has approval under an EUA for the pre-exposure prevention of COVID-19 in adults and pediatric individuals at a higher risk of an inadequate immune response. This population includes immunocompromised people, such as those with cancer or transplant patients or anyone taking medicines that suppress the immune system. Eligibility Criteria: Adults and pediatric individuals (12 years of age and older weighing at least 88 pounds 40 kg): Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, AND: Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, OR For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s). COVID-19 Protection Vs. Traditional Vaccine Route Though current COVID-19 vaccines are safe, well-tolerated, and effective, individuals with compromised immune systems face a different challenge. In some instances, some patients who are immunocompromised might not generate a robust enough immune response. As a result, they may remain susceptible to contracting COVID-19, even with completing a full vaccine series. In addition, the risk for severe illness is higher in immunocompromised people. One reason is because the virus can survive longer in their bodies. Evusheld is the latest research breakthrough providing hope to one of the most vulnerable populations in the ongoing COVID-19 pandemic. Now, “normal” is a little bit closer for even more individuals. At Arizona Clinical Trials and Arizona Liver Health, we specialize in conducting clinical research studies to improve care options for liver diseases and other conditions. We are excited about what Evusheld means for individuals with compromised immune systems due to the advanced stages of liver disease. In the meantime, we are still offering FREE fibroscans to adults at risk of liver disease and research studies you can join to help advance treatments for conditions that affect the liver. To learn more, contact us today at (480) 360-4000 or visit our website. Sources: https://www.health.com/condition/infectious-diseases/coronavirus/immunocompromised-covid-vaccine https://www.upmc.com/coronavirus/monoclonal-antibodies/immunocompromised-patients https://www.astrazeneca.com/media-centre/press-releases/2022/evusheld-long-acting-antibody-combination-recommended-for-approval-in-the-eu-for-the-pre-exposure-prophylaxis-prevention-of-covid-19.html https://www.fda.gov/media/154702/download

COVID-19: Omicron

January 13, 2022 No Comments

At this point in the COVID-19 pandemic, it feels like we are navigating the different levels of a video game. Except this isn’t a video game, this is real life amid the COVID-19 pandemic. When vaccines drove the infection rates down, up popped the Delta variant. Now, the COVID-19 variant Omicron is spreading at lightning speed. Why and How Viruses Mutate Viruses are constantly making copies of themselves to reproduce. Over time, random changes (mutations) occur in the copies. Most times, these mutations are so small that there’s no change in how the virus behaves. If enough mutations arise, a new variation or strain of the virus can emerge. Omicron As we are barely gaining ground on COVID-19 two years later, it’s understandable our knowledge of Omicron is minimal. We don’t yet know: How easily it spreads The severity of illness it causes How well available vaccines and medications work against it Based on the changed genetic makeup and initial observations reported in those infected, the CDC lists the following information about Omicron: The Omicron variant likely will spread more quickly than the original SARS-CoV-2 virus. Anyone with Omicron infection can spread the virus to others, even if they are vaccinated or don’t have symptoms. Some treatments are likely to remain effective, while others may be less effective. Vaccinate, Get Your Booster, and Join the Fight to End COVID-19 Scientists and health officials expect that current vaccines will continue to protect against severe illness, hospitalizations, and deaths due to infection with the Omicron variant. However, it’s still possible for breakthrough infections to occur in fully vaccinated people. Vaccines have remained effective in preventing severe disease, hospitalization, and death with other variants like Delta. The emergence of Omicron further emphasizes the importance of vaccination and boosters. Arizona Clinical Trials offers COVID-19 resources through our clinical trials. Explore your options today! Visit our website to complete the application to see if you qualify.

We are Still Your COVID-19 Resource Center

December 31, 2021 No Comments

It’s hard to believe that we were glued to our television sets two years ago, watching the growing impact of the virus we know as COVID-19. With a second virus variation on the rise, the fight to end COVID-19 endures. Arizona Clinical Trials intends to see it through like the numerous other entities that have joined forces. Until then, we are still your COVID-19 resource center. COVID-19 by the Numbers More than 277 million confirmed COVID-19 cases and more than 5 million associated deaths globally. The United States has had more than 51 million confirmed cases and over 812,000 associated deaths. More than 70 percent of U.S. adults are fully vaccinated with vaccines available to ages 5 and up and boosters for ages 16 and older. What’s New On December 16th, the CDC made the recommendation that individuals still needing vaccination should avoid the Johnson and Johnson vaccine. This was in response to a small blood clot risk which has hospitalized 54 people and taken the lives of 9. Researchers found the Omicron variant grows 70 times faster than the delta one in the bronchial tubes. Officials are still uncertain how many boosters are necessary to effectively fight the virus. Data shows deaths from COVID-19 in 2021 surpassed deaths in 2020. Vaccine mandates prevail in some areas and meet stiff opposition in others in an effort to slow the spread of COVID-19. For example, a federal judge blocked a vaccine mandate for healthcare workers, while the U.S Navy says that sailors forgoing the vaccine would face discharge starting in 2022. Your Resource Center for COVID-19 Though the progress remains steady, we still need your help in the fight to end COVID-19. Arizona Clinical Trials is still offering: FREE screenings for COVID-19 for those who are experiencing symptoms. Potential enrollment into COVID-19 prevention and treatment trials for healthy individuals or those with symptoms of the virus. (Participants must meet all eligibility criteria) To learn more, call us at (480) 360-4000 or visit our website today! Sources: https://www.healthline.com/health-news/covid-19-updates#12/2/21-3:09-p.m.-PST-Biden-announces-new-COVID-19-strategy https://www.reuters.com/business/healthcare-pharmaceuticals/what-you-need-know-about-coronavirus-right-now-2021-03-02/

Signs That You May Have Already Had COVID-19

September 15, 2021 No Comments

COVID-19 has affected the lives of millions of people around the world since late 2019. You can also be asymptomatic, meaning you have no symptoms but still are carrying the virus. With this in mind, a lot of people have been asking themselves if they have already had the virus because some of the symptoms are similar to the common cold. We’ve come up with a list of signs and symptoms that could indicate whether you may have already had COVID-19 without realizing it. Symptoms of COVID-19 Unfortunately, there’s no way to be 100% certain whether the bad cold you developed last season was COVID-19, but here are some possible signs that you may have already had coronavirus. Cough – Do you have a cough that won’t go away? The CDC reported over 40% of people experienced a dry cough for weeks after having COVID. Fatigue – Fatigue is one of the biggest lingering effects after COVID-19. New loss of taste or smell – Loss of taste or smell is a hallmark symptom of COVID. While it’s possible to experience this with other respiratory illnesses, If you experienced this at any point, you may have had COVID-19. Shortness of breath or trouble breathing – Lasting inflammation in the lungs can be cause for shortness of breath or trouble breathing. Other symptoms that are all associated with COVID-19 include body aches, stuffy nose or runny nose, fever or chills, headache, and sore throat. Testing for COVID-19 In addition to knowing the symptoms of COVID-19, you should know the various tests available for the virus. There are two forms of testing for COVID-19: a viral test or an antibody test. The viral test shows if you currently are carrying the virus. The antibody test shows any past exposure to COVID-19. An antibody test is not recommended to assess immunity after a COVID-19 vaccination. Click here to learn more about testing for COVID-19 and to find out where you can get tested at a testing site near you. Please note that just because you may have had these symptoms, does not mean you had COVID-19. The only sure way of knowing is by undergoing testing specifically for the COVID-19 virus. If you believe you might have COVID-19, FREE testing is available at Arizona Clinical Trials. If you know that you have COVID-19, consider looking into clinical trials that may be an option. Clinical trials are important for the future of overcoming COVID-19. Participating in a COVID-19 clinical allows you to be a part of history. Helping evaluate future treatments for COVID-19 is vital to improving the lives of those living with this virus. Are you interested in COVID-19 clinical trials or getting a free COVID-19 test? Learn more by clicking here. Sources: https://www.healthline.com/health/sure-signs-you-ve-already-had-covid#signs

Not sure if you're symptoms are COVID-19 related?

COVID: Know When to Get Tested

July 29, 2021 No Comments

49.2% of the U.S. population is fully vaccinated against COVID-19 at the current writing of this blog. After months of decline, new cases are rising again. In part, thanks to things like the delta variant, vaccine hesitancy, and July 4th gatherings. If anything, the rise in cases should solidify the fact the COVID-19 is still prevalent. Therefore, we should still know the symptoms and when to get tested at the very least. So, here’s your updated refresher. COVID-19 Symptoms COVID-19 has a wide range of symptoms. Some only get mild symptoms, and others develop severe illness. Symptoms typically appear anywhere from 2-14 days after exposure to the virus. Common symptoms include: Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or runny nose Nausea or vomiting Diarrhea As far as the delta variant, we are still learning about it. Unfortunately, this means there is a limit to the information available. We know that it seems to spread faster than the alphavirus variant first detected in Wuhan, China. So far, studies suggest that authorized vaccines offer strong protection against severe disease and death from the delta variant. As scientists and researchers continue efforts to understand these variants better, more information will become available. When to Test, and When not To. Anyone should undergo testing who is experiencing symptoms, regardless of their vaccination status. Other situations warrant testing if you don’t have COVID-19 symptoms. According to the CDC, if you don’t have symptoms and are not fully vaccinated, you should still be tested if you: Had close contact with someone with confirmed COVID-19, This is including someone who does not have symptoms within ten days of their positive test result. Are an individual who’s taken part in activities that put you at higher risk for COVID-19. Attending large social or mass gatherings or being in crowded indoor settings are examples. Belong to a prioritized group for expanded community screening for COVID-19. Have been asked or referred to get testing by your school or workplace. If you are a healthcare provider or a member of a state, tribal, local, or territorial health department. You can find the interim recommendations for fully vaccinated individuals here. Are you Experiencing COVID-19 Symptoms? If you’re experiencing COVID-19 symptoms, we can test you for FREE here at Arizona Clinical Trials. Those with a positive test may be eligible to participate in enrolling COVID-19 clinical trials. Don’t delay; we can test you today! Call (480) 360-4000 to schedule your appointment, or visit our website to learn more! Sources: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html https://www.worldometers.info/coronavirus/ https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html https://www.washingtonpost.com/health/2021/07/07/delta-variant-covid/

COVID-19: It’s Not Over Yet

May 20, 2021 No Comments

As vaccine doses increase and mask mandates lift, it’s hard to imagine how much work is left to do in ending the COVID-19 pandemic. Numbers are trending down, and while that’s great news, scientists, researchers, and health officials work diligently to increase our knowledge of the virus and expand how we detect, treat, and prevent it. The end may be closer than ever, but it’s not over. The fight to end COVID-19 pushes on and your help is needed more than ever. Research Studies are Vital to Ending COVID-19 The virus that causes COVID-19 isn’t new. However, the symptoms it triggers categorizes it into a new type of coronavirus. This means we would need new ways to detect, manage, and prevent this specific strain. Clinical research studies help us learn more about the virus. The information we learn can re-purpose previously approved therapies and design potential new ones. Research studies also play a vital role in evaluating how effective and safe potential new therapies are as they interact with the human body after lab evaluation. After completing all required phases of research, the FDA reviews the data and issues an approval or denial. Every FDA-approved therapy and device has gone through this process. Expanding Options and the Finish Line During extreme emergencies such as public health crises, the FDA can issue Emergency Use Authorization to potential new therapies. An EUA permits the public distribution and the use of unapproved drugs. Or, unapproved uses of approved medicines under specific guidelines. For COVID-19, one treatment thus far has full FDA approval. Remdesivir was developed over a decade ago. It received approval last year in late October to treat adults and children sick enough to need hospitalization. All three vaccines in circulation are under emergency use, along with treatments including: Monoclonal antibodies Antivirals Immune modulators Convalescent plasma The progress thus far is without a doubt thanks to the continued efforts of clinical research studies and those individuals who participate in them. Work continues to expand options for covering variants of the virus, younger patients, disease stage, and symptom severities. Also, to gather the remaining data needed to move those options under emergency use to full FDA approval. Are You Experiencing COVID-19 Symptoms? Clinical research participants are the lifeblood of medical advances. Hundreds of thousands of individuals to date have joined in the unprecedented fight to end COVID-19. We will need many more before the end. If you are experiencing symptoms of COVID-19, Arizona Clinical Trials is offering FREE testing! Those with a positive result will be given the opportunity to see if they are eligible to participate in enrolling clinical trials. Get tested and get involved today! Call us at (480) 360-4000 or visit our website. References: https://www.healthline.com/health-news/heres-exactly-where-were-at-with-vaccines-and-treatments-for-covid-19#Antivirals https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines#:~:text=The%20FDA%20has%20regulatory%20processes,include%20adolescents%2012%20through%2015. https://www.infectioncontroltoday.com/view/end-of-the-covid-19-pandemic-so-close-and-yet-

5 myths and 5 facts about COVID-19 vaccines

5 Facts and Myths About COVID-19 Vaccines

April 30, 2021 No Comments

Accurate vaccine information is critical now that there are authorized and recommended COVID-19 vaccines in the U.S. Knowing which sources of information you can trust can be complex. You may have heard claims about the vaccines on social media or from family or friends. Or the rapid development and approval of these vaccines may have made you hesitant about their safety or effectiveness. The truth is, vaccines are the best chance we have of ending COVID-19. It’s time to set the record straight and get the facts behind 5 of the most common myths about COVID-19 vaccines. Top 5 Myths Busted Myth #1: The COVID-19 vaccine was rushed, so it can’t be safe. Truth: The CDC said it best, “COVID-19 vaccines are safe and effective. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met FDA’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA). “ Millions of people in the United States have received COVID-19 vaccines, and these vaccines will undergo the most intensive safety monitoring in U.S. history. This monitoring includes using both established and new safety monitoring systems to ensure that COVID-19 vaccines are safe. Myth #2: It will alter your DNA. Truth: Both mRNA and viral vector COVID-19 vaccines deliver instructions (genetic material) to our cells to fight COVID-19. However, it never enters the nucleus of the cell, where we keep our DNA. The genetic material in the vaccines cannot affect or interact in any way with our DNA. Myth #3: If you’ve already had COVID-19, you don’t need to get the vaccine. Truth: There are severe health risks associated with COVID-19, and it is possible to get reinfected. Therefore, individuals may benefit from getting the vaccine. Myth #4: The vaccine will deliver a microchip into your body. Truth: This myth was started after a comment made by Bill Gates about vaccine registry and wasn’t even referring to a microchip. There is no vaccine microchip, and the vaccine will not gather any personal information or track people. Myth #5: It affects fertility. Truth: Currently, there is no evidence that COVID-19 vaccination causes any problems with pregnancy, and there is no evidence that fertility problems are a side effect of any vaccine, including COVID-19 vaccines. The Truth is Out There When researching the COVID-19 vaccines on the internet, check that the information comes from a credible source that is updated regularly. Millions of people have been affected by this virus, but together, we can help to end COVID-19. Arizona Clinical Trials offers FREE COVID-19 screenings and conducts research studies looking into potential new ways to treat and prevent it. To learn how you can get involved, call 480-360-4000, or visit our website. References: https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-19-vaccines-myth-versus-fact https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html https://www.mayoclinichealthsystem.org/hometown-health/featured-topic/covid-19-vaccine-myths-debunked

Safer at Home: Treating COVID-19

March 27, 2021 No Comments

thoughAfter a diagnosis of COVID-19, most patients with mild cases return home to quarantine and begin recovery. The thought may sound daunting, but don’t worry. With the proper precautions and knowing the warning signs, you do it. When treating mild cases of COVID-19, you are safer at home. Caring for Yourself, Caring for Others Whether you are caring for yourself or a loved one, there are a few things to keep in mind when recovering at home. Make sure to follow all safety protocols because the safety of the patient and caregiver is equally important. Recovery Area The patient should have a separate room with private bathroom access, if possible. If not, a sectioned area in a room will work. The bathroom would need to be sanitized after each use as well. Protect Yourself and Others A person must be isolated in quarantine for up to 10 days after the first symptoms began and 24 hours after being fever-free. Depending on the person recovering, the doctor may require a longer time. Use a face mask Wash your hands often Cough into a tissue that you throw away immediately Clean frequently touched surfaces often Don’t share personal items, like dishes, towels, or bedding. Wash all items thoroughly. Managing Symptoms Take Tylenol to help reduce fevers Stay hydrated by drinking water or juice Resting will give your body the energy it needs to fight off the virus Warning Signs Call 911 immediately if you are having a hard time waking the patient up or they are showing any of the other warning signs: Breathing trouble Chest pain or pressure that is not alleviated New confusion Bluish color of lips or face Inability to stay awake COVID-19 Positive Adults Research Clinical research studies help develop safe and effective ways to diagnose, treat, and prevent conditions like COVID-19. Research studies are why we have vaccines and other therapies available to help patients beat the virus. Without volunteers participating in research studies, these advancements wouldn’t be possible. Though we’ve come a long way, the battle is far from over. A diagnosis of COVID-19 can often come with an overwhelming sense of helplessness. But as research continues, everyone willing and able can help in the fight to end COVIID-19. If you have a positive diagnosis of COVID-19 within the last 96 hours, research studies here at Arizona Clinical Trials may be an option. Contact us at 480-360-4000 to learn more, or visit our website. References: https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/treating-covid-19-at-home/art-20483273 https://www.umms.org/coronavirus/what-to-know/treat-covid-at-home

COVID-19 Household

November 10, 2020 No Comments

When the coronavirus pandemic hit, we cleared store shelves to prepare for what we feared was the worst. Families of healthcare workers, emergency responders, and other high-risk positions set up decontamination protocols in their homes in hopes of avoiding infection. Unfortunately, COVID-19 can still hit your household, despite all precautions. With a little preparation and determination, your family can get through it in the safest possible way. Challenges of a COVID-19 Household When someone is diagnosed in your family, the main thing is isolating them to prevent the virus from spreading. However, space and their function in the family role can make this a real challenge, among other things. Tasks shift from two to one, which puts pressure on the other partner who is likely already maxed out. This is true especially if there are children involved. Stress and emotions can build up for who it all falls on, and fear and guilt in the sick family member. The challenges may vary from home to home, but it’s tough any way you look at it. Separate but Unified Dealing with a loved one who has COVID-19 can be a scary experience. Even though you are separated from your loved one, you can help them get better and keep everyone else safe by staying the course. There are many things to remember when it comes to taking care of someone with COVID-19. We understand that everyone’s situation is different, but these can be used as a guide to get started and can be modified: Function as a Unit: Identify one person who isn’t in the high-risk categories to care for the sick person. A separate person should be responsible for family members who need help with daily tasks like bathing, cleaning, and eating. Separate Space: Pick a sick room and bathroom. If this cannot be achieved, separate a space in a shared room by a divider, and maintain 6 feet of distance at all times. The sick person should clean a shared bathroom after each use. All shared areas should be well-ventilated and cleaned frequently. Keep Your Distance: Maintain 6 feet away from those who are sick at all times. Ill family members should not prepare food and should eat separately from others. Lastly, don’t forget to take care of you. Reach out if you are overwhelmed or need help so you can get the support needed. Changing the Future of COVID-19 Having COVID-19 and being in isolation can make you feel like a burden as you struggle to let others care for you. It’s hard to ride out not only the illness symptoms themselves but also complete quarantine after. Just keep in mind that your most significant role is keeping your family safe. By separation, you are doing that. Researchers and other health experts have all hands-on deck as they work to find ways to diagnose, treat, and prevent COVID-19. Clinical research studies are being conducted right now, which are looking into some of the promising options in the fight against COVID-19. The volunteers participating in studies make this possible. If you or a loved one have COVID-19, you have a unique opportunity to change the virus’s future. To learn if volunteering in COVID trials here at Arizona Clinical Trials is right for you, visit our website for more information, or call (480) 360-4000. References: https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/living-in-close-quarters.html

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COVID-19 Clinical Research Archives - AZ Clinical Trials

COVID-19, Evusheld, and Liver Patients

COVID-19: Omicron

We are Still Your COVID-19 Resource Center

Signs That You May Have Already Had COVID-19

COVID: Know When to Get Tested

COVID-19: It’s Not Over Yet

5 Facts and Myths About COVID-19 Vaccines

Safer at Home: Treating COVID-19

COVID-19 Household

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