How Safe are COVID-19 Steroids, Antivirals and Antibody Cocktails?

President Trump’s confirmation of his positive coronavirus diagnosis is further proof that COVID cares not who you are and what you have; it can come for you anyway.

As of October 7, 2020, there are more than 7.6 million confirmed cases of coronavirus in the United States, with a total of 36.3 million cases and 1.1 million fatalities worldwide. 

Organizations like the World Health Organization (WHO), the Center for Diseases Control and Prevention (CDC) and the Food & Drug Administration (FDA) are working with scientists around the world to find a cure for coronavirus. In the meantime, there are many other treatments being considered and employed.

[ Read: You Don’t Need a UVC Wand to Kill COVID-19 ]


How Is Coronavirus Being Treated?

According to the Pharmaceutical Journal, “Current approaches to COVID-19 therapies generally fall into two categories: antivirals — which prevent the virus from multiplying — and immune modulators — which help the immune system to fight the virus or stop it from overreacting dangerously.” 

The publication goes on to provide a complete listing of all medications currently in testing and development, before continuing on to say, “Only evidence from randomized controlled trials comprising more than 100 participants is included, with the exception of select observational studies that have had a significant influence on ongoing research.”

“I think that it is far too soon to comment with any certainty about the risk/benefits of steroids, antivirals or antibody treatments for C19,” says Dr. Ceppie Merry, FRCPI PhD. As a student at Northwestern Chicago, Dr. Merry completed a fellowship specifically on infectious diseases.

“Some of these therapeutic agents are new to us,” she continues, “but even the agents with which we have a long history of use (steroids), we still have limited experience in using them for C19.”

[ Read: How to Protect Your Family After Being Discharged From the Hospital With COVID ]

President Trump’s COVID Treatment

President Trump’s diagnosis made headlines as much as his treatment. But, what were these treatments, and are they effective in the battle against coronavirus? With the President serving as the latest guinea pig for COVID treatment, scientists will be watching closely to see whether this is a treatment routine that can be replicated for the masses. 

We take a deep dive into the current medical landscape with the help of the country’s leading academics and its implications on the coronavirus pandemic.

Regeneron

On October 2, 2020, Trump was reported to have been administered eight grams of the experimental antibody treatment REGN-COV2 from creator Regeneron. It is more than three times the normal dose, with studies touting the effectiveness of just 2.4 grams. 

George Yancopoulos, co-founder and chief scientific officer of Regeneron, says that the President likely received the higher dose out of “an abundance of caution” and understands the need to err on the side of caution. “If I had to treat one patient, I’d give the high dose,” he says. “From a societal point of view and the need to treat as many people as possible, I’d give the lower dose.” 

Of course, that could change should the drug prove successful.

The monoclonal antibody treatment includes two antibodies: one from an infected patient, the other from a mouse specifically engineered to replicate a human immune system. It was tested on both golden hamsters and rhesus macaques (a type of Old World monkey), before researchers moved onto patients already infected with coronavirus. Results show that the drug’s benefits were twofold, as it is able to successfully reduce viral load while shortening symptomatic disease.  

Patients tested exhibited minor to moderate symptoms, in line with the President’s own symptoms. Researchers hope that the drug will also be useful in treating more severe cases.

Remdesivir

The President is also being given a round of remdesivir in a five-day treatment period. This is an antiviral drug that has been shown to provide moderate results and is administered intravenously. Those on ventilators are recommended treatment for ten days instead of the standard five.

For President Trump, it was administered in response to lowered oxygen levels. “We decided that in this case, the potential benefits early on in the course probably outweighed the risks,” White House Physician, Dr. Sean Conley explained.

This drug is the brainchild of Gilead Sciences, but it wasn’t created solely for COVID. It first existed to treat Hepatitis C and Ebola, but results were found to be lackluster. It has had better results against COVID, with “a modest clinical benefit.” Therefore, it is being used as a treatment for more mild cases.

Dr. Anthony Fauci, long-time Director of the National Institute of Allergy and Infectious Diseases (NIAID), said remdesivir will be “the standard of care” at an April meeting. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent,” he said. “It is a very important proof of concept. What it has proven is that a drug can block this virus.”

The drug has been shown to increase liver enzymes, leading to inflammation of the liver or liver cell damage. The FDA reports that side effects also include the usual infusion-related risks of low blood pressure, sweating, shivering, nausea or vomiting.

Upon review, the National Institutes of Health (NIH) ruled against remdesivir treatments for COVID patients without supplemental needs for oxygen. “No survival benefit was seen among participants who did not require oxygen therapy at enrollment,” it said. “Patients with severe COVID-19 can develop a systemic (all-of-body) inflammatory response that can lead to lung injury and multisystem organ dysfunction,” it said.

Dexamethasone

The President’s steroid treatment is called dexamethasone, and so far, it is the only treatment that has been shown to decrease mortality in severe cases of COVID-19. Recent UK trials show that it is especially effective in patients who are critically ill. 

While dexamethasone was chosen for the President’s lowered blood oxygen levels, it’s a steroid that is usually reserved for breathing issues, as well as arthritis, lupus, ulcerative colitis.

However, there have been reports that it is actually harmful when administered in the earlier stages of the disease. Its side effects are also concerning, honing in on your mental health with symptoms that can include paranoia, psychosis, aggression, agitation, anxiety, irritability and depression. 

Hydroxychloroquine

This is the drug most synonymous with coronavirus. It is an antimalarial treatment that has dominated the headlines in recent weeks, as experts debate its efficacy.

Hydroxychloroquine is used in the treatment of malaria, but it has also emerged as a useful treatment against auto-immune diseases like arthritis and lupus. Studies from the Henry Ford Health System also show that it can reduce fatalities in hospitalized patients already infected with COVID.  

However, not all medical experts are convinced. “There is no evidence that hydroxychloroquine has any positive effects in COVID-19 and its use should be strongly discouraged,” says Dr. Goldenberg firmly.

Other treatments in testing

Today, there is a joint global effort currently underway to research and expand access to COVID vaccines. Called COVAX, it is being overseen by WHO, Gavi and CEPI, and its members include 156 countries. The US, Russia and China have all declined to join.

Some of the drugs currently in testing by COVAX include the following:

  • Eli Lilly is another drug using antibodies that is in testing by Regeneron, using another antibody that has so far produced encouraging results. 
  • Famotidine, or more commonly known as Pepcid, is typically used for heartburn but could have possible benefits for coronavirus.
  • Intranasal spray from Australia’s Ena Respiratory is still in testing but has shown promising results in its testing on ferrets, with up to a 96% decrease in COVID viral RNA levels.
  • mRNA-1273 from Moderna has shown to be a neutralizing vaccine in a small trial affecting adults 55 years of age and older. 

Conley also reports the President is taking these supplements:

  • Zinc – a natural nutrient that boosts the immune system
  • Vitamin D – a natural nutrient to increase bone health
  • Famotidine – a drug that reduces the amount of acid in your stomach, typically treating ulcers, heartburn and indigestion
  • Melatonin – a brain hormone that has been shown to help fight inflammation, obesity and diabetes, as well as other viruses
  • Daily aspirin – an over-the-counter staple that can reduce blood clots, a symptom of some COVID patients.

Any of these alone are not treatments for COVID, but together, they provide a body-boosting cocktail that gives extra power in fighting the virus. 


Availability of COVID-19 Treatments 

Regeneron

In addition to the President’s treatment, Regeneron is currently only available to participants of clinical trials. There is a loophole where physicians can request compassionate use via the U.S. Food and Drug Administration’s “expanded access” exemption.  

Regeneron is considering the possibility of pursuing an emergency use authorization (EUA) from the FDA.  

Former Food and Drug Administration Commissioner Scott Gottlieb told CNBC, “It’s not going to be a cure, but it is going to be a drug potentially that if you use it particularly early in the course of a disease,” he said. “You hang it in the emergency room when someone comes in with COVID, especially someone with risk factors that predict they’ll have a worse outcome from the disease —  it could reduce their chances of having a really bad outcome.” 

Regeneron is not yet equipped to serve the masses, instead operating by physician-requested EUAs. “There is limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis,” the company said.

Remdesivir

This is the only treatment that has been in active use since it was granted its EUA in May. 

At the time, FDA Commissioner Stephen Hahn explained, “This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with COVID-19 and is the first authorized therapy for COVID-19.” 

Dr. Don L. Goldenberg is the Emeritus Professor of Medicine at Tufts University School Of Medicine and author of How the COVID-19 Pandemic Is Affecting You and Your Healthcare. “Antiviral medications, specifically Remdesivir, and antibody cocktails have demonstrated some benefit in patients with mild to moderate COVID, especially when used early,” he says. “Preliminary reports of an antibody cocktail demonstrated that it may be useful to prevent hospitalization but these results need to be confirmed and because of the cost, it is unlikely that such treatment will be generally available in the near future.”

It was first cleared by the FDA to treat COVID patients with breathing problems, but at the end of August, the FDA revised its ruling to allow for all hospitalized patients to receive access to the drug, as requested by their physicians.

To help, Gilead donated its entire existing supply to the treatment of infected patients, contributing a minimum of 140,000 treatment courses. 

Gilead also vowed to increase manufacturing efforts in a later statement. “The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required.”

Hydroxychloroquine

Taken orally, the CDC fact sheet says that it is safe for use in patients of all ages. It is also safe for pregnant and nursing women. It is, however, not intended for anyone with psoriasis. Also known as hydroxychloroquine sulfate or under the generic prescription name of Plaquenil, you must have a physician’s prescription for access to treatment. After false promises from initial tests, the FDA issued a EUA in March but later revoked the authorization in June when further testing failed to yield any real results. 

“Most hospitalized patients currently do receive Remdesivir, and anyone with significant pulmonary compromise should also receive dexamethasone,” summarizes Dr. Goldenberg. “A short course, usually 3 days, of dexamethasone is quite safe although adverse side effects, like delirium, can occur and patients should be observed in the hospital.


The Bottom Line

When it comes to available COVID treatments, all parties agree more research and testing is needed. It seems like the President’s treatment was an experienced shot in the dark, a very educated guess, because when it comes to a coronavirus cure, there still is no solution.  

As Dr. Merry says, “All that we can hope to do is our best, on any given day, with the information that is available at that time.”


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Contributing Writer

Lena Borrelli

Lena Borrelli is a freelance journalist who has covered home security, safety, and other topics for Safety.com, TIME, Microsoft News, ADT, and Home Advisor.