By Patrick Jackson
Even with three highly effective vaccines available in abundance throughout the country, the delta variant of SARS-CoV-2 continues to cause a large number of new infections, particularly in states where vaccination rates remain low. What’s more, as schools and businesses reopen and the holiday season approaches, another rise in infections may be on the way.
here is, however, some good news. Numerous medications, including fledgling and repurposed drugs, are accessible. For hospitalized COVID-19 patients, these new treatments, along with supportive care advances – such as placing some patients on their stomachs in a “prone position” – were helping bring down mortality rates before the Delta variant hit and are continuing to improve patient outcomes today.
As an infectious diseases physician and scientist, I have been working to find new treatments for patients since the pandemic’s beginning. Here’s a look at some of them, with one caveat: While these medications might help many patients, none substitute for the vaccine, which is still the best defense against the virus.
The right drug at the right time
COVID-19 has two main phases.
In the early stage of the disease, the SARS-CoV-2 virus replicates in the body; the virus itself causes illness. Within the first 10 days or so, the immune system eliminates the virus, but this process can cause collateral damage.
A second phase of the disease may kick in, which occurs when the patient has a disordered inflammatory response.
That’s why it’s critical to use the right treatment drug at the right time. For instance, an antiviral drug may help a patient with early and mild symptoms. But it’s not useful for someone on a ventilator after weeks in the hospital.
Conversely, patients in the ICU might benefit from an inflammation-reducing drug, which can prevent damage to organs such as the kidney and lungs; this damage is called sepsis. But the same drug used during the viral phase of disease might hamper a patient’s ability to fight off COVID-19.
Antiviral drugs
Three antiviral monoclonal antibody drugs authorized for use in the U.S. may keep the virus from infecting new cells by targeting the SARS-CoV2 spike protein. For outpatients with early COVID-19, these drugs reduce the risk of hospitalization and death. One of them – REGEN-COV – may prevent high-risk patients from getting sick.
These antiviral drugs might also help hospitalized patients whose bodies are unable to make antibodies on their own, either because of immune-compromising drugs or an impaired immune system from another condition.
One study that has not yet been peer reviewed shows that hospitalized patients with no natural antiviral antibodies had a reduced risk of dying after receiving one of these drugs. But that treatment is typically unavailable except through a compassionate-use program. To get the medication for a patient, a physician must ask both the drug manufacturer and the FDA for approval.
Another problem: Administering these antiviral drugs on a large scale is a challenge. Health care workers must give them shortly after the start of symptoms. The infusion or injection must be in a monitored setting. Patients may find it difficult to quickly access the treatment.
Mixed signals on remdesivir
One of these antiviral drugs, remdesivir, shows activity in the lab against a broad range of viruses, including coronaviruses like SARS-CoV-2. It works by blocking the virus from making more copies of its genetic material.
Two clinical trials performed early in the pandemic show that remdesivir shortens recovery time for hospitalized COVID-19 patients. A more recent trial suggested it reduced the risk of death. But two additional trials, one conducted primarily in low- and middle-income countries by the World Health Organization and another in Western Europe, did not show a clear benefit of remdesivir in hospitalized patients.
The medical community has interpreted the conflicting data in different ways. Remdesivir received FDA approval to treat COVID-19; both the Infectious Diseases Society of America and the National Institutes of Health recommend the drug for hospitalized patients. But the World Health Organization does not, at least outside of a clinical trial.
Anti-inflammatory drugs
Steroids like dexamethasone can broadly suppress the immune system and, in turn, reduce inflammation. For hospitalized patients, a regimen of dexamethasone decreased the risk of death, according to a February 2021 study published in the New England Journal of Medicine. The benefit was greatest for patients requiring the most respiratory support. But in the same study, for patients with no need for oxygen therapy, dexamethasone had no benefit, and in fact could be harmful.
IL-6 inhibitors
Steroids are a blunt instrument for immune suppression; other anti-inflammatory drugs affect the immune system more precisely. Critically ill COVID-19 patients with inflammation may have elevated levels of the IL-6 cytokine, a molecule the immune system uses to coordinate a response. For these patients, both tocilizumab and sarilumab – two drugs that block cells from responding to IL-6 – may reduce inflammation and decrease mortality when combined with dexamethasone.
JAK inhibitors
A class of drugs called JAK inhibitors – JAK being shorthand for a family of enzymes called Janus kinases – may also modify the body’s inflammatory response. They are used for some autoimmune conditions, including rheumatoid arthritis, and they block inflammation caused by IL-6.
Adding baricitinib, a JAK inhibitor, to remdesivir helped hospitalized patients recover faster than using remdesivir alone. Baricitinib also reduced mortality in hospitalized patients treated with dexamethasone. And, with the sickest COVID-19 patients, it helped reduce inflammation.
Of the drugs discussed, at the moment only the antiviral monoclonal antibodies are available for doctors to prescribe for patients who are not in the hospital. There is still a clear need for other drugs to help patients with early symptoms who are not hospitalized. Older medications that may be repurposed to treat these patients include inhaled costicosteroids and fluvoxamine, an antidepressant.
A dangerous trend
As for the now-controversial drug ivermectin: Preliminary results from one randomized, placebo-controlled trial did not show any benefit for COVID-19 treatment. Two more trials, also randomized and placebo-controlled, are underway.
For now, based on current evidence, ivermectin should not be used to treat COVID-19 patients. When used incorrectly, this drug could cause serious harm. Ivermectin has been approved for treatment of parasitic worms and head lice; but using it off-label to treat COVID-19 has resulted in overdoses and hospitalizations. Ivermectin toxicity can cause nausea, vomiting, diarrhea, low blood pressure, confusion, seizures and death.
The urgent search for COVID-19 treatments has highlighted the need for high-quality science. Early on, limited studies led some to believe that hydroxychloroquine would be useful for COVID-19. But over time, more rigorous research showed the drug to have no value for COVID-19 treatment.
Randomized, placebo-controlled trials – in which patients are randomly assigned to receive either the test drug or a placebo – represent medicine’s gold standard. They help doctors avoid the many sources of bias that can lead us to conclude a drug is helpful when it really isn’t. Going forward, it is this kind of research – and evidence – that is essential to finding new and effective COVID-19 treatments.
Patrick Jackson is Assistant Professor of Infectious Diseases at the University of Virginia.
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marlee says
Will Insurance cover these Meds?
I read that monoclonal antibody drugs are costly…$2,000 for each infusion.
Correct me if I’m wrong.
FlaglerLive says
Monoclonal treatment such as the one offered at Daytona State’s Palm Coast campus is a federal program, offered free of charge, like the vaccine. It is not a replacement for the vaccine.
DaleL says
It is true that the monoclonal treatment is paid for by our tax dollars, but a hospital stay is not. Hospitalization, even with decent insurance, can be very costly. The best way to avoid personally testing any of these COVID-19 treatments is to get fully vaccinated!
Further, the average cost of hospitalization from COVID-19 runs a bit over $20,000. Even with good insurance, that typically results in an out of pocket cost of hundreds to several thousand dollars. The best way to avoid this is to get fully vaccinated!
https://www.healthsystemtracker.org/brief/unvaccinated-covid-patients-cost-the-u-s-health-system-billions-of-dollars/
Percy's mother says
Dear DaleL:
I WAS fully vaccinated. Actually I was one of the first in the county to get vaccinated back in January (Moderna)
Though being fully vaccinated, I’m just getting over a breakthrough case of COVID. It just about killed me. I am still recovering . . . slowly.
HOWEVER, DaleL, I already knew about Regeneron aka monoclonal antibody infusion. At the time, there was no infusion center in Palm Coast, so I had to drive to Ormond Beach to the Regeneron aka monoclonal antibody infusion offered there.
I credit Regeneron aka monoclonal antibody infusion (4 shots into fat) saving me from a hospital admission.
So really, your point is moot based on my experience.
The dude says
Yeah well after the first five days of school my 10yo came home and started running a fever. Got her tested 3 days later and she was positive. My vaccinated wife and myself never got so much as a sniffle.
There’s going to be “breakthrough” cases, they said that up front for anyone who paid attention. Some of those breakthrough cases will not have a good outcome.
It’s a numbers game. Fewer seriously ill patients equals a better outcome in general.
marlee says
I heard this last night……….Officials in several states are voicing concern over shortages of monoclonal antibody drugs used to treat COVID-19 patients.
Sherry says
Here’s the thing. . . unless the pharmaceutical company is just “giving away” those drugs for FREE, and unless the doctors and hospitals that administer them are also “giving away” their services for FREE. . . there is a very hefty bill to be paid. Will it then be paid by “we the tax payers”?
Reminds me of the old adage that still remains true: “An Ounce of Prevention is Worth a Pound of Cure”!
GET VACCINATED. . . if for no other reason, it’s cheaper. . . whatever it takes!
Jim Dana says
So easy – get the vaccination – quick and easy. Just as was the polio drops we got as kids – as soon as it came out – my parents took us to our local school to get them. In the “olden days” we all had to suffer through the chicken pox, measles and mumps (which as a result – I lost hearing in one of my ears). And yes – vaccinations are so much cheaper than huge medical bills.
Percy's mother says
Please see my reply above to DaleL.
COVID does not differentiate between vaccinated and unvaccinated.
What is a lifesaver is Regeneron aka monoclonal antibody infusion IF you get a breakthrough case as I did . . . AND I was wearing a mask everywhere, washing my hands AND washing my groceries before putting them away, wearing a glove to pump gas, etc. To reiterate, I was fully vaccinated (Moderna) in January (2 shots to be specific).
COVID does not differentiate. Are you vaccinated? Don’t think you’re protected, because you ARE NOT.
Now if (or should I say, WHEN) you get “IT” and you are against “we the taxpayers” paying for Regeneron aka monoclonal antibodies, then by all means WHEN you get your breakthrough case, by all means DON’T go for an infusion of monoclonal antibodies because you’re against “we the taxpayers” footing the bill.
I’m thankful it was available to me even ‘tho I had to drive to Ormond Beach to get it. And by the way, there were many, many people there getting the infusion, most very ill as was I and barely able to hold their heads up while waiting.
Cases aren’t being counted these days because the only testing available is home testing, and those cases aren’t reported. So we don’t really how how many “breakthrough” cases there are.
Vaccination does NOT mean prevention.
DaleL says
Over 1/2 of all adult Floridians are fully vaccinated against COVID. If the vaccines were not effective in greatly reducing the risk of severe disease, then the hospitalization rates of the vaccinated and unvaccinated would be similar. They are NOT. The unvaccinated minority makes up the vast majority of hospitalizations and DEATH. Vaccination is prevention. Monoclonal antibodies is treatment after infection. It should not be substituted for vaccination.
As is widely reported, most people who are vaccinated either have no symptoms or mild symptoms should they be exposed to COVID. https://www.fox13news.com/news/half-of-florida-covid-19-hospitalizations-under-55-96-unvaccinated
What Else Is New says
My college student niece was vaccinated yet was infected months later, receiving the monoclonal drug as an out patient. Recovering.
Sherry says
https://www.wesh.com/article/central-florida-health-officials-more-than-90-of-covid-19-hospitalizations-are-unvaccinated-people/37170824
Yes. . . the data says that Covid does effect the unvaccinated massively more than those who have been vaccinated. My focus clearly was on those who stubbornly remain unvaccinated. . . since they are “by far” the majority of the ones who are getting ill and continuing to spread this lethal disease.
Do try and look at the bigger picture. The terrible “break through” cases would logically be far fewer if only those who still remain unvaccinated would step up and do the right thing for us ALL. The ripple effects caused by the unvaccinated are crippling our return to any semblance of normalcy, including our country’s financial (tax payer) well being. NOTHING is FREE when it comes to health care. . . someone always pays in the end. . . we are all in this together. . . “that” is the (expletive deleted) point!