With SMH Infectious Diseases Pharmacy Manager Dr. Jamie Kisgen
Thanks to the efforts of the federal Centers for Disease Control (CDC), the World Health Organization (WHO), top medical institutions and others, COVID-19 information is widely available online. Unfortunately, misinformation is also widely available.
To get the facts on COVID-19 treatment and medications — and debunk some common mistruths — Healthe-Matters editors reached out to Dr. Jamie Kisgen, Sarasota Memorial’s Infectious Diseases Pharmacy manager. In this update to a March 2020 Ask An Expert Q&A, Dr. Kisgen addresses some of the most frequently asked questions related to medications for patients with COVID-19.
What is the Treatment for COVID-19 Infection?
Treatment plans for patients who test positive for COVID-19 include infection prevention and control measures (washing hands, use of personal protective equipment, isolating the patient), as well as supportive care, such as supplementary oxygen and using a mechanical ventilator, when needed.
To date, there are no medications approved by the U.S. Food and Drug Administration (FDA) specifically for the treatment of patients with COVID-19. However, medications designed for other uses are being given in some COVID-19 cases, and several investigational drugs are being studied in clinical trials around the globe in an effort to identify a COVID-19-specific medication.
What treatments are available at Sarasota Memorial and do we have enough medications right now to meet the demand?
Due to the global pandemic, there is a high demand for medications that have potential therapeutic benefit for patients infected with COVID-19. This has led to periodic shortages and limited availability of some medications.
Remdesivir – This investigational intravenous (IV) antiviral drug has been shown to decrease the duration of illness in patients hospitalized with COVID-19 who require low amounts of supplemental oxygen. At this time, studies have not shown a significant benefit for the treatment of hospitalized patients who do not require oxygen or those with severe disease on mechanical ventilation. In May, the FDA granted an Emergency Use Authorization (EUA) for Remdesivir, and SMH continues to work with the state and federal government to ensure we have access for our patients. We currently have enough available to treat patients admitted with COVID-19 who meet criteria.
Dexamethasone – This oral and IV steroid is commonly used for a variety of inflammatory diseases, including arthritis and allergic reactions. Recent studies have shown that dexamethasone can improve survival 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 disease who are not on supplemental oxygen and/or not admitted to the hospital is not recommended at this time. Steroids can have significant side effects, including elevated blood sugars, psychiatric symptoms, and they can impair the immune system, making patients you more susceptible to other infections. Close monitoring by a physician is recommended. SMH currently has enough dexamethasone available to treat patients admitted with COVID-19 who meet criteria.
Convalescent Plasma – Donated blood plasma from patients who have recovered from COVID-19 may contain antibodies to SARS-CoV-2 that may help suppress the virus and modify the inflammatory response. SMH was one of the first hospitals in Florida to provide this therapy to COVID-19 patients. We are currently enrolled in a large convalescent plasma study led by the Mayo Clinic. If you or someone you know tested positive for COVID-19 AND have fully recovered from the illness, please contact SunCoast Blood Centers to schedule a plasma donation.
Regeneron REGN-COV2 Antibody Cocktail – SMH is currently a site for several randomized, placebo-controlled trials studying a new investigational monoclonal antibody combination drug for the treatment and prevention of COVID-19. Click here for more information on the clinical trial. For study specifics and eligibility questions, please call the SMH Clinical Research Center at 941-917-2225 (8 am-3 pm, Monday-Friday).
Do Hydroxychloroquine & Azithromycin Help Patients with COVID-19? Are these Being Used to Treat COVID-19 Patients?
As noted above, the FDA has not approved any medication specifically for treating COVID-19.
Azithromycin — An antibiotic commonly used to treat bacterial respiratory infections and thought by some to help fight COVID-19 related inflammation, azithromycin does NOT have any direct activity against viruses, including the novel coronavirus that causes COVID-19.
Hydroxychloroquine — Oral prescription drugs, hydroxychloroquine (Plaquenil) and chloroquine are used to treat malaria and certain inflammatory conditions, such as lupus and rheumatoid arthritis.
National Guidelines currently recommend against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19, except in a clinical trial.
There have been multiple studies looking at the potential use of these agents for treating COVID-19. But not all drug studies are created equal.
To know if a drug truly works or not, we have to test it. The best way for us to test if 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 looking at the role of Hydroxychloroquine +/- Azithromycin for the treatment of patients with COVID-19. They have studied it in a variety of patients, including those who were hospitalized, had mild disease or as prevention (prophylaxis). None of the studies to date have shown any benefit of hydroxychloroquine for the treatment or prevention of COVID-19.
Randomized, placebo controlled trial data showing NO CLINICAL BENEFIT of Hydroxychloroquine for the treatment of COVID-19 include:
Combination — Routine use of the combination of hydroxychloroquine/azithromycin for COVID-19 is currently not recommended.
Clinical studies to date have shown mixed results, with several showing potential harm from the combination. There is a clinically significant drug interaction when azithromycin is taken in combination with hydroxychloroquine. For example, if you give both medications to high-risk cardiac patients, there is an increased risk that they will develop an abnormal heart rhythm.
Do Non-Steroidal Anti-inflammatory Drugs (NSAIDs), like ibuprofen & Advil, worsen symptoms of COVID-19?
Despite what you’ve likely seen in your social-media newsfeeds, there is no scientific evidence to support the claim that taking ibuprofen or Advil will worsen COVID-19 symptoms. Neither the World Health Organization (WHO) nor the FDA advise against the use of ibuprofen or other NSAIDs, based on currently available information.
If you use NSAIDs to help manage chronic health conditions, talk to your prescribing physician before making any decision to stop taking them, as there is no evidence at this point to suggest you should.
For more information on medications and COVID-19, visit these online resources:
• CDC on Therapeutic Options for COVID-19 Patients
• FDA on non-steroidal anti-inflammatory drugs (NSAIDs) and COVID-19
Have a question for an SMH expert? Email it firstname.lastname@example.org.
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.
** NOTE: This content was originally posted on March 31, 2020, but was updated Aug. 18, 2020. Data and information related to COVID-19 are continually evolving. For the most up to date info, we recommend visiting the CDC’s website at https://www.cdc.gov/coronavirus/2019-nCoV/index.html.