With SMH Infectious Diseases Pharmacy Manager Jamie Kisgen
Throughout the COVID-19 pandemic, the medical, public health and clinical research communities have continually worked to better understand the virus that causes COVID-19, how to prevent it and how to treat it.
It’s evident that the best prevention tool we have is vaccination, but what has changed in the way hospitals and physicians are treating patients with COVID-19, since our last blog post on the topic in February 2021? To find out, we talked with Dr. Jamie Kisgen, Sarasota Memorial’s Infectious Diseases Pharmacy manager, about effective treatments for inpatients and outpatients with COVID-19, as well as the use — and misuse — of drugs like ivermectin and hydroxychloroquine.
What is the course of treatment for inpatients with COVID-19 infection?
When patients are hospitalized with COVID-19, treatment plans combine medications (see below) and supportive care, such as supplementary oxygen and a mechanical ventilator, when needed.
What treatments are being used for Sarasota Memorial inpatients?
There is high demand globally for medications that have potential therapeutic benefit for patients with COVID-19. This has led to periodic shortages and limited availability of some medications. However, Sarasota Memorial Hospital-Sarasota Campus (SMH) currently has enough available to treat inpatients with COVID-19 who meet relevant criteria.
Remdesivir — Approved by the U.S. Food and Drug Administration (FDA) for treating COVID-19 in hospitalized patients ages 12 and older, Remdesivir is an intravenous (IV) antiviral drug known to reduce illness duration among patients with COVID-19 who require supplemental oxygen while they’re in the hospital.
However, Remdesivir has not been shown to have a significant benefit for patients with mild to moderate cases of COVID-19 (those who don’t need oxygen supplemented) or for patients with severe illness requiring mechanical ventilation.
Dexamethasone — An oral and IV steroid, dexamethasone is commonly used to treat a variety of inflammatory diseases, including arthritis and allergic reactions. Studies have shown that it can improve survival chances in patients with severe COVID-19 who require supplemental oxygen or mechanical ventilation.
Routine use of dexamethasone or other steroids in patients with mild COVID-19 (not on supplemental oxygen or not hospitalized) is not recommended at this time. Steroids can have significant side effects, including elevated blood sugars and psychiatric symptoms; they can impair the immune system, making patients more susceptible to other infections. Close monitoring by a physician is recommended.
Tocilizumab — An intravenous, immune-modulating monoclonal antibody, Tocilizumab is FDA approved for treating the autoimmune, inflammatory disease rheumatoid arthritis.
A major challenge with COVID-19 infection is that it can trigger a harmful inflammatory response in patients. For those who develop excess inflammation, care providers can prescribe immune-modulating medications like Tocilizumab to inhibit the body’s inflammatory response to COVID-19.
Shown in studies to shorten COVID-19 illness duration and reduce the risk of death in select hospitalized patients, Tocilizumab was given FDA emergency use authorization (EUA) in June 2021 as a COVID-19 treatment for patients meeting certain criteria.
Current evidence and national guidelines limit Tociliuzmab’s use in COVID-19 treatment to hospitalized patients with severe disease and systemic inflammation, who are on supplemental oxygen, high-flow oxygen or mechanical ventilation, with rapidly increasing oxygen needs.
Due to Tocilizumab’s high demand and limited capacity for manufacturing it, there have been intermittent disruptions in its availability.
Baricitinib — Another immune-modulating medication, Baricitinib is also FDA approved for treating rheumatoid arthritis. In studies as a COVID-19 treatment, Baricitinib was shown to shorten illness and reduce deaths among select hospitalized patients with severe disease.
In November 2020, it was given FDA emergency use authorization for the treatment of COVID-19 with guideline recommendations similar to Tociliuzmab. An oral medication, Baricitinib is authorized for use in treating hospitalized COVID-19 patients with severe disease and systemic inflammation, who are on supplemental oxygen and whose oxygen needs are rapidly increasing.
CaTT Clinical Trial — Throughout the pandemic, SMH has participated in multi-national clinical trials focusing on COVID-19 prevention and treatment. Currently, SMH is participating in the multi-center study of IC14. Researchers hope this anti-CD14 monoclonal antibody drug will reduce dangerous levels of inflammation in hospitalized COVID-19 patients. Click here to learn more.
What treatments are available for patients with COVID-19 who are not hospitalized?
Monoclonal Antibody Therapy — Sarasota Memorial is among a number of hospitals that have been allocated monoclonal antibody therapy for non-hospitalized patients diagnosed with mild-to-moderate COVID-19. To be eligible for monoclonal antibody therapy, patients must have been diagnosed within the previous 10 days and must have a high risk for severe disease or hospitalization. SMH has a screening process to determine patient eligibility, and a physician referral is required. Click here to learn more.
The state of Florida also is now providing monoclonal antibody treatment at sites in Sarasota and Manatee counties for people age 12 and older who are high-risk and have contracted or been exposed to COVID-19. Treatment at these state-supported sites is free and does not require a physician referral. Click here for more information or to make an appointment.
It's important to note that the monoclonal antibody treatment can neutralize the spike protein in COVID-19 vaccines, rendering them ineffective. Anyone who receives the monoclonal antibody treatment should wait 90 days before getting any COVID-19 vaccine injections.
Does Ivermectin help patients with COVID-19? Is it being used to treat COVID-19 patients?
Ivermectin, an anti-parasitic drug, is approved by the FDA to treat scabies and several neglected tropical diseases.
Ivermectin is NOT approved by the FDA for preventing or treating COVID-19. It is NOT authorized by the FDA for preventing or treating COVID-19.
Clinical trials and observational studies evaluating ivermectin for COVID-19 prevention or treatment in humans have yielded insufficient evidence. Most of the studies to date either have incomplete information or significant limitations, making it difficult to draw definite conclusions.
in COVID-19 Treatment
Randomized, placebo-controlled trials showing NO CLINICAL BENEFIT of hydroxychloroquine in COVID-19 treatment have included, but are not limited to:
National Guidelines recommend NOT using ivermectin for hospitalized patients or outpatients with COVID-19, unless it is in the context of a clinical trial. Data from well-designed and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in treating COVID-19.
According to the CDC, reports of ivermectin misuse and overdose are on the rise — as are calls to poison control centers reporting overdoses. Ivermectin overdose commonly causes gastrointestinal issues (nausea, vomiting, diarrhea), can increase side effects of other drugs and can even lead to death.
Side effects of misusing ivermectin can also include:
- Low blood pressure (hypotension)
- Confusion and decreased consciousness
- Neurologic complications (hallucinations, seizures, coma, etc.)
We are all eager to find new therapies against COVID-19, particularly oral medications that are readily available. But any potential therapies must be evaluated for both safety and efficacy through gold-standard, scientific studies before adopting widespread use.
Is hydroxychloroquine an effective COVID-19 treatment?
Oral prescription drugs, hydroxychloroquine (Plaquenil) and chloroquine are designed to treat malaria and certain inflammatory conditions, such as lupus and rheumatoid arthritis.
National Guidelines currently recommend NOT using chloroquine or hydroxychloroquine for treating COVID-19 in non-hospitalized or hospitalized patients.
To know if a drug truly works, we have to test it. The best way to determine whether a drug is safe and effective is a randomized, placebo-controlled trial. This involves giving one group of patients the drug(s) you want to test and giving another group a placebo (sugar pill).
To date, there have been multiple randomized, placebo-controlled trials studying Hydroxychloroquine +/- Azithromycin in COVID-19 treatment. None have shown any benefit of hydroxychloroquine for the treatment or prevention of COVID-19.
Is Azithromycin an effective COVID-19 treatment? Is it Being Used to Treat COVID-19 Patients?
in COVID-19 Treatment
Randomized, placebo-controlled trials showing NO CLINICAL BENEFIT of azithromycin for the treatment of COVID-19 have included, but are not limited to:
Azithromycin is an antibiotic commonly used to treat bacterial respiratory infections. Early in the pandemic, it was thought by some to help fight the inflammation triggered by COVID-19.
However, azithromycin does NOT have any direct activity against viruses, including the novel coronavirus that causes COVID-19, and it has not been shown to improve time to recovery, hospitalization incidence or duration, or mortality.
National Guidelines currently recommend NOT using azithromycin to treat COVID-19 in non-hospitalized or hospitalized patients.
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Dr. Jamie Kisgen, PharmD, BCPS, BCIDP, is the pharmacy manager of Infectious Diseases Services at Sarasota Memorial and leads the PGY1 Pharmacy Practice Residency Program. His responsibilities include co-directing the Antibiotic Stewardship Program, providing staff education, research, and precepting pharmacy students and residents.