COVID-19

Courage is often caused by fear. — French proverb

https://www.centerwatch.com/articles/topic/2770

SNAPSHOT: http://www.clinicaltrials.gov:

  • Total number of clinical trials, worldwide: 3,890
  • Total number of clinical trials, worldwide, currently recruiting, 2,021
  • Total number of clinical trials, not yet recruiting, worldwide: 861
  • Total number of clinical trails, United States: 882
  • Total number of clinicals trials, recruiting, United States: 542
  • Total number of clinical trails, not yet recruiting, United States: 101
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If you or a loved one has been stricken with this terrible scourge, read up! Never in the history of medicine has research progressed at such a manic or more fruitful pace than today’s global rush to create a vaccine and find new treatments for COVID-19. And that requires thousands of clinical trials to find substances that are safe and effective. You and yours may well be able to find a trial, but you need to act fast, and arm yourself with the latest information.

I’m going to lay it out for you here. There is a reality you must always bear in mind when evaluating clinical trials. Is it a placebo-controlled trial? That generally means that half of the patients accepted into a trial receive the actual drug being studied, while the other half get a dummy concoction, whether it’s a pill, or a shot, or an IV infusion. Placebo-controlled trials are typically “double-blinded,” meaning that neither the patient nor the medical staff administering the medication will know the difference.

But it’s also important to note that sometimes when placebo-controlled trials demonstrate clear evidence that the real drug is working, those on the placebo wing of the trial will begin receiving it, instead of a placebo. And here’s another thought to ponder: speaking strictly for myself here, if I were very sick with COVID-19 and not responding to the best treatment available, I’d rather have a 50-50 crack at getting a new drug than doing nothing at all. But this is a vital question everyone entering a placebo-controlled trial must ask themselves.

Before joining any trial, however, I would of course want to learn everything that is known about the risks and side effects of the experimental drug, as well as its possible benefits. Phase 1 trials are the riskiest, because they typically indicate that the substance has never been tested on humans.

My own father entered a very aggressive phase 1 trial when he had stage IV prostate cancer that had metastasized to his bones and liver, because he wanted what he felt offered him a possible breakthrough, and he hit the jackpot: within a few months he was in remission, and went on to live a very rich and wonderful life for nearly 10 years, even though he was already 71 years old when he was diagnosed.

Other patients did not fare well, and ultimately no one other than Dad was able to withstand the chemo regimen. This was despite the fact that chemo was given only three days per month in this unique trial, and only until remission was achieved. Just to illustrate how differently drugs can work, despite nausea and some initial vomiting, Dad was easily able to withstand the chemo … and didn’t even lose his hair! You can learn more by reading the My Story page.

If it’s a phase 2, 3, or 4 trial, however, the medical team will have plenty of information to share with you about how the drug performed in previous trials. Not only will they have information available regarding the risks and possible benefits of the drug or treatment, they are required, for legal reasons, to provide you with this information, to ensure that when you are truly giving your “informed consent” when you sign up for the trial.

THE SAME DRUG PRESIDENT TRUMP RECEIVED … RIGHT DOWN THE STREET?

Want to find a clinical trial for COVID-19? There are so many trials going on across the nation, that, figuratively speaking, you can practically “throw a rock in any direction.” I just went to Google and searched for “Covid trials near me,” and in a few moments I found a site in Falls Church, Va., less than 10 miles away, offering a trial funded by Regeneron Pharmaceuticals. Yes, I have an edge, because I live in a large area with a lot of medical research. But let’s continue.

Does the name sound familiar? Yes, that Regeneron: The same company that created the experimental drug used on President Trump. It’s being offered as part of a clinical trial right down the road from me (and in other locations across the nation), and, oh yes – if you can manage to get yourself admitted into a trial, it’s free.

“On 2 October, the White House announced President Donald Trump received an experimental antibody treatment after a test revealed he’s infected with [COVID-19],” according to Science Magazine.

The treatment was “a combination of two antibodies directed against a key protein of the virus that causes COVID-19, SARS-CoV-2. They bind to a region on the main surface spike protein that helps the virus attach to a receptor on human cells called angiotensin-converting enzyme 2,” the magazine continued, in an October 5 news report.

“The targeted region is dubbed the receptor binding domain. One antibody comes from a human who had recovered from a SARS-CoV-2 infection; a B cell that makes the antibody was harvested from the person’s blood and the genes for the immune protein isolated and copied. The other antibody is from a mouse, which was engineered to have a human immune system, that had the spike protein injected into it.”

USE MEDLINEPLUS.GOV TO SIMPLIFY CONFUSING MEDICAL INFORMATION

Does that sound complicated? Well, yes and no. There is a staggering amount of science behind a beautiful fall day, but do you really need to know it all, or do you just need to know the road to Walden Pond? Further to the point, there’s an art to reading medical articles, and if you start by going to medlineplus.gov, which is NIH’s incredibly useful health information website, you’ll find the latest medical information on any disease or medical condition, written in relatively plain language that you can understand.

Once I did that, as well as a little more reading online, I came to understand that the familiar red spikes that stud the surface of the COVID-19 cell are what it uses to attach itself to human cells and infect them. But Regeneron’s agents, known as Anti-Spike Monoclonal Antibodies, bind to the spikes, rendering them harmless. Now, is that complicated? It works in much the same manner as antibiotics have been used to fight bacterial infections for more than seven decades.

THE ENORMOUS PROMISE OF MONOCLONAL ANTIBODIES

Does this sound exciting? You bet. Artificial antibodies are one of the most promising new areas of COVID-19 research, and there are a number of similar drugs in the pipeline. The first one of them, Bamlanivimab, created by Eli Lilly and Company, received emergency approval from the U.S. Food and Drug Administration (FDA) on Nov. 9, 2020. FDA greenlighted the drug for patients 12 years and above who are at high risk for progressing to severe COVID-19 and/or hospitalization, according to the company.

This is great news, and none too soon, as the death toll from COVID-19 continues to climb at an alarming rate. The only problem is that there aren’t nearly enough doses of Bamlanivimab available to help the staggering number of patients who might benefit from it. Drugs like this are even more important when you consider the fact that forthcoming COVID-19 vaccines may not be the silver bullet we’re all hoping for in the short term, at certainly, for a number of reasons I’ll address further down.

So, if you’re not one of the lucky few able to get treated with Bamlanivimab, you cannot get any of these artificial antibodies from any hospital or any doctor. Unless you’re the president of the United States or another really big shot, the only way you, as a regular citizen, can get them is through a clinical trial.

Yet these are the very drugs that may have been partially responsible for the remarkably quick recovery the President made. It’s impossible to know for sure, because Trump was treated with so many drugs over the course of his illness.

These included Remedesivir, a relatively new and extremely expensive antiviral medication, as well as Dexamethasone, a much older, and inexpensive steroid medication; zinc, vitamin D, Famotidine, which is generic form of Pepcid AC, an over-the-counter heartburn drug; melatonin, which is also available over the counter; and a daily aspirin, according to a statement released by his medical team.

WHAT IS THE BEST WAY TO FIND COVID-19 CLINICAL TRIALS?

Although I would never discourage anyone from going onto the Web and searching for “clinical trials near me,” or by any other means, you can get to the motherlode much quicker by simply going to clinicaltrials.gov, and using their remarkably user-friendly search engine to find trials for any disease or medical condition.

Within seconds you can search by nation, by state, by city, by zip code, and by number of miles from your home. You can also search by drugs used. You can plug in monoclonal antibodies, for instance, and find out exactly where those trials are being offered. Better yet, just plug in monoclonal to save time and possibly yield more results. Or just antibodies. It’s truly amazing. Why not give it a shot right now?

The only problem with searching by other means is that you may stumble onto a trial, get very excited about it, and possibly even get admitted to the trial, without realizing that there were even better options available for you.

So I recommend starting with clinicaltrials.gov from the get-go and getting a bird’s eye view of the entire picture. Once there you can also harness the incredible number of other features offered on the website. Does it all sound too good to be true? It, may, but don’t forget: you, as the American taxpayer, paid for this website, and you paid a lot. NIH received a seven percent funding increase in fiscal year 2020, bringing the agency’s total budget to an eye-popping $42 billion. It is one of America’s crown jewels, the greatest medical research and health information agency in the world. Nothing else approaching its size and scope exists anywhere.

And yet still I am dumbfounded by how few people are even aware of this remarkable resource and database. Search tips: Always begin your search by looking at trials “currently recruiting.” That will give you the great bulk of open trials. After that, however, be sure to look trials “not yet recruiting.” That’s because many of the trials listed will begin in weeks or even days!

When you find a trial that you’re interested in joining or learning more about, simply call or email the contacts listed on the trial record with all your questions. And do it now. Why wait? That initial phone call or email could very well be the first step toward getting into that trial. And always bear this in mind: Those people listed as contacts, typically a nurse or other members of the research team are waiting to hear from you just as badly as you want to talk to them!

Clinical trials cannot move forward if they do not recruit the requisite number of patients, and a sizable number of trials are simply scrapped because they cannot find enough volunteers. NOTE: I cover this subject in much greater detail in the Clinical Trials page on this website.

WHERE ELSE TO SEARCH FOR COVID-19 TRIALS

Once you have the lay of the land, by all means have at it! Search by whatever means strike you as logical and obvious. You might start indeed by plugging “clinical trials for covid near me” into your search engine (There’s no need to capitalize your search terminology). Search online for clinical trials by location, by hospital, by medical societies, and by drug companies. By all means, speak with your local doctors and anyone you know in healthcare. You might indeed find a trial right in local area. Or in the nearest big city. There is always the chance that you may find a trial that, for one reason or another, is not listed, or is not yet listed, on clinicaltrials.gov.

Spend as much times as you have looking elsewhere for trials, but remain cognizant that time is a very precious commodity when you contract COVID-19, and clinicaltrials.gov is your biggest, best, and quickest source. And if you need my help in any way, please turn to the Services page to see what I offer.

NOW IS THE TIME TO SEARCH FOR COVID-19 TREATMENTS!

There is a double-edged sword when it comes to clinical trials for COVID-19. On the one hand, research is exploding at a feverish pace, with new trials springing up every week, with many patients needed for them, but on the other hand, getting into one can be fraught with logistical and medical obstacles if you wait until you are desperately ill.

THE BAD NEWS

If you are critically ill and being treated in an intensive care unit (ICU), it’s going to be difficult, and possibly dangerous, to get transferred to another hospital offering a clinical trial. If also presents a severe challenge to already overstressed and overstretched hospital resources, both human and otherwise.

Why am I telling you this? Because it would be cavalier and offering false hope unless I qualify it.

To get an idea of how complicated the manoever can be, take a look at a look at the following abstract of the Cleveland Clinic Journal of Medicine article, published in June 2020, Interhospital transport of patients with COVID-19: Cleveland Clinic approach. You can read the article online at https://www.ccjm.org/content/early/2020/06/04/ccjm.87a.ccc045

ABSTRACT

What follows is an abstract of the full text:

Hospital-to-hospital transportation of patients in the COVID-19 era presents unique challenges to ensuring the safety of both patients and health care providers. Crucial factors to address include having adequate supplies of protective equipment and ensuring their appropriate use, defining patient care procedures during transport, and decontamination post-transport. Transport vehicles need to have adequate physical space, an isolated driver compartment, NS HEPA filtration of air. Having a standardized intake process can help identify patients who would benefit from transport to another facility.

THE GOOD NEWS

The good news, however, is that – to repeat myself – patients are needed, and needed badly for these trials. And the “principal investigators,” a term that means the doctors and scientists heading up these trials, cannot move forward with them unless they can find enough participants. And they’re going to do whatever it takes, within reason, and given sufficient resources, to find patients to fill their quota.

But they are going to look first at patients already hospitalized at the hospitals and research centers where they already practice medicine. But if they run out of willing and available recruits, then they will be more likely to help out. And, if accepted into a trial, it will be the responsibility of the principal investigators to provide transport to their research centers, more so than the responsibility of the facility where you’re currently hospitalized. Lots of additional work will still be required on both ends, however.

SO, WHAT CAN YOU DO TO INCREASE YOUR ODDS?

When is the right time to search for COVID-19 treatments? Now, before you even become sick! I’m watching ABC World News Tonight as I write this section. Thanksgiving 2020 is fast approaching, and COVID-19 is surging across the nation in the second wave, sickening a million new people in just 11 days. Hospitals and intensive care units are running out of room