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Do you have a COVID-19 Preparedness Plan?

(Brandpoint) – If you’re concerned about getting COVID-19, you have good cause.

According to the latest COVID-19 Data Tracker from the Centers for Disease Control and Prevention (CDC), the U.S. alone has already logged over 16.3 million cases and the overall weekly hospitalization rate is at its highest since the pandemic began.

While it’s critical to stay informed about the spread of the virus and know how to protect yourself and others, many people may not realize how important it is to be prepared with an action plan should an outbreak occur in your community or household.

The better informed you are, the more empowered you can feel about coping with the pandemic. 


COVID-19 Preparedness Tips from a Professional Patient Advocate Who was Hospitalized

Professionally, Michelle Vogel works in patient advocacy and provider relations, helping other patients navigate the healthcare system. That experience has taught her that sometimes, patients must be proactive and push to find their best options. Preparing as much as possible in advance is paramount.

Have a testing plan. Know the symptoms and if you have been exposed or experience symptoms, know where to get tested in your area, and know how you’ll isolate or self-quarantine if necessary. Relevant information is listed and regularly updated on the CDC website

Get to know the hospitals in your area. Look up local and regional hospitals in your area and make a plan for where you would seek treatment if you needed to be hospitalized. If you want access to investigational treatment candidates, websites like www.StopStorm.com can help you find research hospitals in your region as they may be enrolling people in clinical trials. 

Ask about treatments and clinical trials. Everyone reacts differently to the coronavirus. As such, there’s no one-size-fits-all approach when it comes to treatment. If you’re hospitalized with COVID-19, ask about treatment options and if you may be eligible to enroll in a clinical trial. Since eligibility criteria can change, it’s important to keep asking your hospital and doctor about clinical trials daily.

Throughout this crisis, the biotech and pharmaceutical industries have worked tirelessly to develop vaccines and therapeutics to help overcome this pandemic. However, with over 4,000 COVID-19 clinical trials listed on www.clinicaltrials.gov and the healthcare system almost overwhelmed, the burden to get access to clinical trials is now often falling to the patient or their families who may need to proactively plan, ask and engage.

Clinical trials are crucial in the development of innovative medicines and participating in a clinical trial helps advance potential treatment options for people in need.

“Typically, hospital researchers will discuss clinical trial options proactively with patients who may be eligible to enroll,” said Vogel. “I think that there is so much research going on right now, patients and their families have to be more vocal and engaged in asking about potential clinical trials than ever before.”


What Happens When the Professional Patient Advocate Becomes the Patient? 

The expression, ‘when it rains, it pours,’ doesn’t even begin to capture how torrential Michelle Vogel’s experience was with COVID-19. It was the midst of Florida’s hurricane season, the virus was surging in the state and her mom was just diagnosed with COVID-19 in Boynton Beach, Florida, days prior.

While Michelle, a 53-year-old Jacksonville, Florida, resident, waited to get her COVID-19 test, delayed due to heavy storms, her symptoms were getting worse. After her test came back as positive, she went to the research hospital in her area and was admitted to the Mayo Clinic in Jacksonville. She was diagnosed with pneumonia and was treated with convalescent plasma, remdesivir and steroids. Her condition deteriorated and she developed a hyper-response of the immune system that causes harmful inflammation, known as cytokine storm. The condition affects almost 90% of patients hospitalized with COVID-19 and is a leading cause of COVID-19 progression, use of a ventilator and death.

Vogel asked about clinical trials and learned that the Mayo Clinic was one of the sites enrolling patients in a Phase 3 study evaluating lenzilumab, an investigational treatment candidate designed to combat cytokine storm. She pushed to be enrolled in the clinical trial.

The Unsung Heroes

“Patients participating in clinical trials are too often the unsung heroes in the development of innovative treatments and the pandemic has heightened the importance of patient advocacy in the clinical trial process,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen, the biopharmaceutical company developing lenzilumab as a potential COVID-19 treatment. “The global biopharmaceutical industry has made tremendous strides to develop viable COVID-19 vaccines, but we need treatment options for all patients while we wait for widespread safe and effective vaccine use and availability.”

For Michelle Vogel, her condition improved rapidly after participating in the clinical trial. She had read that lenzilumab could help normalize her C-reactive protein and that is what she experienced. Just days later, she was weaned off supplemental oxygen and discharged from the hospital.

“If I hadn’t pushed to see what other options were out there, I don’t know if the lenzilumab trial would’ve been offered,” she said. “Because of my professional experience as a patient advocate, I knew to keep on pushing to see what my options were. But there are many patients who don’t even know that they can ask what their treatment options are.”

Sadly, however, Michelle’s mom passed away from COVID-19 while Michelle was in her own COVID-19 battle. “I tried hard to advocate for the best treatments for my mom but there were no clinical trial options at her hospital and it’s difficult to even think about whether she would have survived if she had access to a clinical trial.”

To learn more and to find a lenzilumab clinical trial site near you, visit www.StopStorm.com.

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Health Information

Clinical Trials for Rare Diseases

The idea of clinical trials is much in the news these days as medical researchers work hard to identify new treatments and vaccines for COVID-19. A clinical trial is a formal research study that, among other things, tests new therapies to see how well they work and if they are safe to use in humans. It’s an essential step in the Food and Drug Administration’s (FDA) process for approving new therapies.

For those who live with rare diseases, though, clinical drug trials have a more direct impact on their day-to-day lives. Many rare disease patients have few or no options when it comes to effective treatment of their symptoms. Even when medications with confirmed effectiveness are prescribed, they often are used without FDA approval (a practice known as off-label use), which sometimes makes it difficult to get insurance to cover the cost.

Getting new medications to market requires extensive testing in order to attain FDA approval. These studies need to have a sizable number of participants in order to show accurate results. That’s not a problem for common diseases like heart disease and cancer. But with so few people with diseases like myositis, myasthenia gravis, or pemphigus, it can be difficult to get enough qualified participants to show clear results.

That’s why many of the patient organizations that we work with encourage their members to consider taking part in a clinical trial if at all possible. This can be a big decision, one that you should discuss with family members and your doctor to be sure they are comfortable with your participation and the role they may need to play in the process. But it’s a great way feel like you are contributing to a cure.

Clinical trials are not limited to testing medications, but here we focus on clinical trials testing safety and effectiveness of new drugs. We’ve outlined answers to some common questions that can help you understand the general process of participation in such trials. Specific questions about a particular trial can be answered by the study coordinator of that trial.

How does a clinical trial work? Each clinical trial follows a strict set of rules outlining who can participate, what processes will be done, how participants are protected against risks, how long the trial is expected to last, and more. This protocol is designed to clearly answer specific research questions about the treatment. These protocols are outlined for all medications being tested in the US on the NIH website ClinicalTrials.gov. Here you can search for a trial based on disease, drug, location, or other criteria. Each trial also has contact information for additional information.

What is informed consent? All research participants have the right to know exactly what they are getting into. Informed consent is the process of providing you with essential information about the study before you decide to take part. Members of the research team will provide written and verbal explanation of the details of the study, including its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. All known risks and potential benefits are also explained and included in the document. Before you decide to sign this document (which means you agree to participate) you should ask questions and be sure you understand everything included in it. It’s important to note that taking part in a clinical trial is voluntary, and you can leave the study at any time. 

Why do some patients not receive the treatment? Clinical trial protocols often involve comparing outcomes of patients who receive the new drug or treatment with those who are given a placebo (a non-active substitute). Most times neither the researcher nor the participant knows whether the drug or a placebo is being given. Participants are usually randomly assigned to the treatment or the placebo group. In this way, researchers can clearly see that the medication was responsible for the effect and not some other cause, such as participants getting better on their own.

What are “phases” of clinical trials? New medications and other treatments take place using a step-by-step process that begins in the laboratory (preclinical phases) then moves on to testing in humans. Each of these phases seeks answers to different questions.

These are the questions posed during each of the phases:

  • Phase 1 – Different doses of the drug are tested for the first time in a small group of healthy people—usually less than 100.
    • What are the side effects?
    • Is this drug safe to continue testing?
  • Phase 2 – The drug is tested in a larger group of people who have the disease—ideally a few hundred (but usually fewer in rare diseases).
    • What are the side effects in this population?
    • Does the drug work as treatment for this specific disease?
  • Phase 3 – The drug is tested in a much larger group of people who have the disease—ideally several hundred to several thousand.
    • What are the side effects?
    • How well does the drug work to treat the disease?
    • How much of the drug should people take?
    • How does the drug compare to currently available treatments?
  • Phase 4 – This phase happens after the drug is approved by the FDA and is being used by patients.
    • What are the long-term effects of the drug?
    • What is the best way to use this drug as treatment?
    • Are there other risks to using this drug?
    • Are there other benefits not previously identified?

How safe are these experiments? While all medical interventions carry some amount of risk, those who participate in clinical trials are not “guinea pigs.” The FDA requires researchers to include in their protocols certain measures to ensure the study is ethical, that the rights and welfare of participants are protected, and that the risks are reasonable when compared to potential benefits. And all research organizations require any protocol that involves human subjects to be reviewed, monitored, and approved by an independent Institutional Review Board (IRB) of scientists and ethicists.

You can learn more about clinical trials at the National Institutes of Health (NIH) website.