Q&A: The evolving data on treating COVID-19 patients

By: - January 25, 2022 5:44 am
Filling Medical Form, document, stethoscope

“The only consistency is inconsistency” as the data on COVID-19 treatments continues to evolve. (Getty Images)

Remdesivir. Monoclonal antibodies. Rheumatoid medication to treat COVID-19. Bills hoping to legitimize ivermectin. Fourteen drugs with emergency use authorization and only one with full approval.

With dueling medical advice from social media and physicians, it’s no wonder ever-evolving COVID-19 treatment is hard to decipher. 

But here’s where it gets really complicated – especially for medical providers: The most-promising options, three of which just got the green light in December, are often in such short supply that physicians must decide which patients need them most. Public health and medical experts continue to say vaccines and boosters are the first line of defense and critical to keeping people with COVID-19 out of the hospital.

With omicron driving new cases and hospitalizations to record levels, we asked Dr. Aalok Khole, an infectious disease expert at Cheshire Medical Center in Keene, to get us up to speed on a pandemic where the only consistency is inconsistency. 

Aalok Khole
Dr. Aalok Khole

In September, we asked you about masking guidance, which like COVID-19 treatment now, was changing week to week. Any advice for those who want an end in sight and a direct path there?

With respect to everything COVID, I think the bottom line that we’ve learned in these past two plus years now – and which we also need the community at large to understand – is that change is inevitable. The data is evolving. Science is evolving, literally by day. If you just look at something that we did last month, we may not be doing it right now.

Early on, our treatment protocol said we really don’t have anything to treat other than we know the steroid dexamethasone works and that remdesivir was just coming out with emergency use authorization. But that was back in the day when people were literally throwing anything at the wall and seeing what sticks. 

We had to pivot. We’ve really not seen the medical fraternity being so nimble, which was the need of the hour when what you’re doing today may not be valid six months later. We all like our black and white with the occasional gray. We’ve had to change our perspectives and mentality (and accept) that we’re going to be in the gray for a while. 

By the time monoclonal antibodies arrived in New Hampshire, most were obsolete because omicron had replaced delta, and it responds to only one type of antibody. What is access to treatment like now?

When the state said it was getting Paxlovid (an oral antiviral), the Dartmouth-Hitchcock health system (which has four hospitals and a Manchester practice) was told we would get about 40 treatment courses every two weeks. 

Irrespective of what you’re asking for, we’re able to get only 50 percent. So when we ask for 12, we may get six. And when you have only six, you cannot wait three days to see who’s the one that would really benefit because by that time point, you’re sitting on the drug and potentially losing out on patients. 

You have to make your best decision on the available data that you have and tweak processes as you go. And a lot of this got complicated because over the holidays, every week a new agent got emergency use authorization. That’s the hardest for the health care system – to make changes on the fly, make changes on the go, but it’s inevitable.

Since May 2020, the Food and Drug Administration has given only one drug, remdesivir, full approval for COVID-19 and 14 others emergency use authorization. Many more have gone through clinical trials or are in development. (Source: FDA authorization timeline)

When you explain the treatment options for COVID-19, you talk about five buckets of patients, from least to most serious. Who’s in the first bucket?

These are the people who test positive for COVID-19 but who don’t need COVID-19-specific treatment at all or don’t have the risk factors to progress to a more serious condition. Essentially, everything’s OK. They are stable at home and should continue isolating and managing their symptoms, if any, with conservative measures like fever-reducing medications, cough suppressants, etc.

You describe bucket two as people with more serious symptoms who can also be treated without hospitalization.

This group is really not dropping their oxygen saturations warranting them to come into the hospital, but they have certain factors in their medical history or their age which make them at high risk for disease progression. 

Factoring in (logistic, supply, and approval) constraints, there are four options that help reduce the likelihood of disease progression and ever having to come into a hospital.

This group would qualify for monoclonal antibodies, which currently for omicron is only the monoclonal sotrovimab. (The Food and Drug Administration has given sotrovimab emergency use authorization for some people ages 12 and up who have mild to moderate COVID-19 symptoms.)

Treatment could also include Pfizer’s Paxlovid (a tablet with the same emergency use authorization found to reduce hospitalization and death in unvaccinated people) and Merck’s Molnupiravir (which has similar approvals but for only adults and was originally designed to treat the flu.)

And some trials have shown benefits of using remdesivir as a three-day protocol in an outpatient setting. (For inpatients, it is a five-day treatment. It is the only treatment to receive full approval from the Food and Drug Administration.) 

The next three groups require hospitalization. Who is in bucket three?

These are people who are admitted with COVID, not really for COVID.

For example, a 70-year old woman falls down, fractures her hip, and comes into the hospital. We do a pre-admission surveillance test and she is incidentally found to be COVID positive. If Jane Doe, 70 years old, had not fractured her hip and was minimally symptomatic, she would be at home and actually be in bucket two.

We treat this group’s primary complaint, but we really are only caring for the COVID from an infection prevention standpoint, meaning people are donning and doffing the right PPE needed to take care of COVID-19 patients. But you’re essentially making sure the infection doesn’t spread. 

And your bucket four group? 

This is someone who came in for COVID-19 needing minimal oxygen support, predominantly for respiratory symptoms like cough, sharpness of breath, lowering oxygen saturation, and/or fever. For these folks, we have two workhorses. One is remdesivir and the other is dexamethasone, a steroid historically used to treat a wide variety of conditions. (These include cancer, arthritis, skin rashes, and blood disorders. It has shown to reduce deaths in patients on ventilators.)

That leaves the most seriously ill who are often in an ICU.

The patients need high-flow oxygen or are getting intubated. The thought process is, from a disease evolution perspective, that it’s not the virus as much that is driving their story, but more a pro-inflammatory phase (which can worsen disease), where it’s the body’s immune response that is accentuating everything.

In addition to the two drugs used for the prior group, we have options that are famous in the rheumatology world: baricitinibsarilumab, and tocilizumab, which have approval or guidance for COVID-19 treatment.)

The issue with these patients is as time goes by, COVID is not the only thing you’re dealing with. Now they may have been in the hospital long enough that they are at risk for hospital-acquired infections because the aim of a lot of these treatment protocols is to suppress the immune response. That makes them more susceptible to what we call opportunistic infections – infections that take advantage of your guard being down.

Ivermectin hasn’t received any level of approval for COVID-19 treatment from the FDA and has not been through any robust studies. Yet, many tout it as the only drug to trust. What are your thoughts?

We’ve not had the time or the inclination to do large-scale trials, but in the small-scale trials which have randomized people to placebo, ivermectin has really not shown any benefit. If anything, when you’re prescribing those high doses (used for research), the likelihood of risks coming out of that are quite high – neurological side effects and seizures. These are things you really don’t want to face because you took a drug which was not meant to treat this infection at a dose which has not been studied. I mean, it’s completely going off the book. 

Just because there is a small study or there is someone who said it works, this ‘let’s all jump on the bandwagon and do it’ doesn’t make sense. However much we want data now and however much we want information now to help make decisions, there are times when you have to pause and think.

With the whole ivermectin debate, I think there’s been enough data to debunk the use. But belief or the lack of it in science and evidence, and the politicizing of health care, unfortunately, has led to this sort of a section of society that really doesn’t want to trust that. And that’s the problem. That’s what’s fueling misinformation campaigns.

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Annmarie Timmins
Annmarie Timmins

Senior reporter Annmarie Timmins is a New Hampshire native who covered state government, courts, and social justice issues for the Concord Monitor for 25 years. During her time with the Monitor, she won a Nieman Fellowship to study journalism and mental health courts at Harvard for a year. She has taught journalism at the University of New Hampshire and writing at the Nackey S. Loeb School of Communications. Email: [email protected]