Santa Barbara Doctors ExtraCare – August 2020 Newsletter

August 2020 ExtraCare Newsletter

It’s hard to believe that summer is almost over. As we ease into Labor Day and the start of a new school year there remains so much uncertainty surrounding the COVID-19 pandemic. We at Santa Barbara Doctors remain committed to keeping you informed of all the latest developments. This month we focus on where we are to date with treatments and vaccines and discuss the potential long term lung damage associated with COVID-19 infection.

Stay safe and hang in there!

Covid 19 Is there a vaccine or cure on our horizon?

As each month of this pandemic goes by, we are learning more and more about this potentially deadly disease.

My email inbox is being inundated with articles about promising potential treatments and vaccines to combat COVID 19. Never before in my career have I seen such a surge in R&D across the globe.

According to the Milken Institute, there are currently 316 treatment trials and 202 vaccine trials being conducted around the world.

Drug developers, academic labs, and other organizations globally are developing many different kinds of medical products to treat COVID-19. Treatments give us tools to help patients while a vaccine is developed. Potential treatments include medicines currently used or studied to treat other diseases (“repurposed” treatments), as well as drugs newly identified or designed to treat COVID-19.

These treatments fall into the following categories:

Antibodies

Antibodies are one of your body’s natural defense systems against foreign attackers. When your body detects foreign intruders (like bacteria or viruses), your immune system makes antibodies that recognizes them. These specific antibodies attach to the foreign intruders and target them for destruction. To treat or prevent disease, scientists can either use antibodies from the blood of people who have recovered from the infection (i.e., “convalescent plasma”) or use antibodies made in a lab that will attach to and stop (“neutralize”) the foreign intruders.

Antibodies created to attach to different molecules in the body (i.e., not foreign intruders) can also be used to treat disease, for example, by turning down your immune response to stop it from overreacting and causing damage to the body (a phenomenon known as “cytokine storm”).

Antivirals

Viruses travel light—they usually only carry a few things they need, including the code to make more of themselves (the “nucleic acid,” either DNA or RNA) and a protective shell around them. They can’t make more of themselves (“replicate”) on their own. They need to get into animal cells, where they hijack the replication system that those cells use. Antiviral treatments stop viruses from making more of themselves by blocking one or more steps in the process. We are currently using the anti-viral Remdesivir at Cottage Hospital to treat patients with severe COVID-19.

Cell-Based Therapies

Cell-based therapies work by transferring into patients live cells to treat a specific disease. To make cell-based therapies, researchers take cells either from the patient (called “autologous” therapies) or from a donor (called “allogeneic”therapies) and either transfer the cells unchanged or change the cells in specific ways to treat a specific disease (e.g., CAR-T therapies). Different cell types from different sources can be used (e.g., stem cells from fat tissue or bone marrow, cells from placenta, T-cells, natural killer [NK] cells). To treat COVID-19 disease, potential cell-based therapies work, in general, by helping the patient’s immune system work better (and not overreact) by releasing signals to other cells in the body to coordinate a proper reaction to the infection and help healing.

Devices

Not all potential therapies to treat COVID-19 are drugs. Some are devices or machines that in some way treat a disease. These potential treatments include blood purification devices that filter patients’ blood to remove excess proteins (e.g., cytokines causing the“cytokine storm”) or toxins that are causing problems that can lead to respiratory or organ failure in patients.

RNA based Treatments

RNA molecules carry instructions that tell our cells how to build the proteins they need. As disease treatments, modified (genetically altered) RNA molecules are given to patients that can block the making of specific harmful proteins (e.g.,antisense therapy) or make particular helpful proteins (e.g., mRNA therapy). To treat COVID-19, RNA-based therapies can, for example, interfere with the virus hijacking our cells to make more copies of itself by blocking the construction of viral proteins.

Scanning Compounds to Repurpose

Research institutions and pharmaceutical companies have “libraries” of drug compounds discovered or made while exploring their potential to treat various diseases, some of which may have gone on to get FDA approval (and are used today to treat patients) and some of which stayed on laboratory shelves. When COVID-19 hit, many of these organizations started looking back at the drugs in these collections to see if they held something that might help. In addition, some researchers are using new technologies like artificial intelligence to try to use characteristics of the virus to find or design drugs that might successfully treat COVID-19.

Other

This “other” drug category is a catchall for anything that doesn’t fit neatly into the other product categories. These potential treatments vary widely in the ways they work, the diseases they treat (for those approved by the Food and Drug Administration [FDA]) or are in development to treat, and how they are given to patients. These drugs include things like steroids, malarial drugs, drugs that treat high blood pressure, cancer drugs, drugs that treat the over-reaction of the immune system seen in some COVID-19 patients (i.e., the “cytokine storm”), drugs that treat autoimmune diseases, and drugs that prevent blood clots.

The now infamous hydroxychloroquine falls into this category. And for those of you who are still asking, the FDA revoked the March 28, 2020 Emergency Use Authorization on June 15, 2020 after several large scale studies were stopped early due to unfavorable results.

Vaccines

Operation Warp Speed (OWS) aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. OWS is a partnership among components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, and the Department of Defense. Congress has directed almost $10 billion to this effort through supplemental funding.

Vaccine development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

A successful vaccine would be able to protect the population from COVID-19. Developers from around the world are exploring different platforms to build vaccines to protect people against COVID-19 disease. Each type offers unique benefits and challenges and we will likely need more than one approved vaccine to vaccinate every person around the globe.

I have listed the most promising vaccine platforms below:

Inactivated Virus

This type of vaccine consists of the disease-causing virus that has been killed (with heat or chemicals), so it won’t make you sick, and can be used in people that may not be able to use a live attenuated virus vaccine (e.g., those who are immunocompromised). Examples of inactivated virus vaccine in use currently include the annual flu vaccine and the inactivated polio vaccine. In general, inactivated virus vaccines do not provide as strong of an immune response as live attenuated virus vaccines, so additional doses of the vaccine may be needed to get a strong enough immune response. In addition, these vaccines tend to take a long time to produce, having to be grown in cultured cell lines or eggs.

There are currently three phase III trials underway using inactivated virus against COVID-19 in China. There are currently no US backed trials or funding for this type of vaccine.

Non-Replicating Viral Vector

In this approach, a viral gene is added to a different, non-replicating, virus and delivered to the vaccine recipient. No approved product of this kind has resulted to date.

One of these vaccines, currently in phase III trials, was developed at the University of Oxford with R&D from several US pharmaceutical companies and was selected for OWS in May 2020.

Protein Subunit

In this approach, rather than introducing whole viruses to an immune system, a fragment of the virus is used to trigger an immune response and stimulate immunity. Examples include the subunit vaccines against hepatitis B and shingles.

One of these vaccines, funded by the US Department of Defense and currently in phase II trials, was also selected for OWS in July 2020.

DNA and RNA-Based Vaccines

DNA-based vaccines work by inserting a genetically engineered blueprint of viral gene(s) into small DNA molecules (called plasmids) for injection into vaccinated people. Cells take in the DNA plasmids and follow their instructions to build viral proteins, which the immune system recognizes as foreign, triggering the immune response that protects against the disease.

Similar to DNA vaccines, RNA-based vaccines provide immunity through introduction of genetic material (RNA). RNA vaccines can also be potentially developed more quickly and easily than other vaccines. No RNA vaccines have been approved for human use to date, although one promising candidate, currently in phase III trials, has been selected for OWS in April 2020 and was granted FDA fast track designation in May 2020.

I am asked daily by my patients when I think a vaccine will be available. While I, as you, hope that the answer is tomorrow, I realize that’s probably not going to be the case. The answer is forthcoming once we gather the data from the hundreds of clinical trials around the globe, many of which are already in phase III. Let’s hope that those brilliant minds of Operation Warp Speed were correct when selecting what they believed were the most promising candidates.

https://covid-19tracker.milkeninstitute.org/

How to keep your lungs healthy in the Covid era:

Despite the multi-organ collateral damage that we’ve been noticing with Covid-19, its greatest morbidity and mortality is still due to lung damage. Extensive research is being conducted to better elucidate how this happens to better identify ways to keep lung function optimal in the Covid era. An important study published July 9, 2020 in the New England Journal of Medicine (Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19 by Dr Ackerman et al.) analyzed advanced Covid-19 lung damage via direct pathologist visualization, CAT scans, genetic analysis, and the highest resolution microscopic methods (including electron microscopy), to better understand what the virus does to lung anatomy and function. The most striking feature identified was unusual “microscopic blood clots” surrounded by immune cells indicative of marked inflammation. Quantitatively, this was up to 2.7x more prominent than lung damage caused by end stage influenza infection.

What does all this mean? Well, for starters, it shows that lung damage due to Covid-19 is far from benign and in fact, may be long lasting. Inasmuch it should not be understated that the best way to preserve lung function in the Covid era is to avoid the virus until the pathological pro-inflammatory state can be best controlled with a vaccine.

At Santa Barbara Doctors we implore you to consider lung health paramount during these challenging times. A few key tips and tricks to optimize lung health include:

Taking all medications as prescribed.If you have asthma or COPD its important to take your inhalers as directed.Poorly controlled asthma or COPD is an intuitive risk factor not just for Covid-19, but for other viral or bacterial pneumonias.
Exercise!Cardiovascular activity is the best way to exercise the lungs.Moreover, ventilation opens up the lungs and allows exchange of carbon dioxide with fresh oxygen.If lung tissue is not utilized, blood flow avoids it and creates nonfunctional “dead space.”
Weight Loss:To piggyback off of point #2, full lung expansion requires the diaphragm to lower to allow the influx of air. Abdominal fat inhibits this and makes it naturally harder to aerate the bases of the lungs.For the best results, a healthy diet can truly optimize lung function by providing more energy for better exercise and weight loss results.
Avoid smoking.And second hand smoke!Did you know that if you smell someone else’s cigarette smoke that you’re inhaling their deeper lung aerosols?Although Santa Barbara is a smoke free city in public spaces, this may be an issue at home if your neighbors have a different vision of wellness.
Wear your mask in public spaces:Keeping your lungs healthy requires work, both as an individual and as a community.Its up to everyone to keep the burden of Covid-19 low to best mitigate transmission.

Our mailing address is:

Barbara A. Hrach M.D. FACP

229 W Pueblo St

Santa Barbara, CA 93105-3804

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