With SMH Infectious Diseases Pharmacy Manager Dr. Jamie Kisgen
NOTE: To view SMH's latest blog post on COVID-19 treatments, click here. The content below was originally posted March 31, 2020, and last updated Feb. 4, 2021.
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 Ask An Expert Q&A (originally posted in March 2020 and last updated in February 2021), Dr. Kisgen addresses some of the most frequently asked questions about current COVID-19 treatment options and clinical trails.
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), medications (see below) for patients who meet criteria based on available evidence. and supportive care, such as supplementary oxygen and using a mechanical ventilator, when needed.
What treatments are available at Sarasota Memorial, and does SMH have enough 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, but SMH currently has enough available to treat inpatients with COVID-19 who meet relevant criteria.
Remdesivir — Remdesivir is approved by the U.S. Food and Drug Administration (FDA) for treating COVID-19 in hospitalized patients ages 12 and older. An intravenous (IV) antiviral drug, Remdesivir has been shown to decrease illness duration in hospitalized patients with COVID-19 who require supplemental oxygen. However, it 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. SMH currently has enough Remdesivir available to treat patients admitted with COVID-19 who meet the criteria.
Dexamethasone — An oral and IV steroid, dexamethasone is commonly used to treat a variety of inflammatory diseases, including arthritis and allergic reactions. Recent 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 (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 and psychiatric symptoms, and they can impair the immune system, making patients 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 relevant criteria.
Baricitinib — An oral immune-modulating medication, Baricitinib is currently FDA approved for treating moderate to severe rheumatoid arthritis. It has been studied as a COVID-19 treatment and was shown to decrease the duration of illness in patients hospitalized with COVID-19. However, it has not shown a significant improvement in survival compared to the standard of care treatment.
In November, Baricitinib was given an emergency use authorization (EUA) for the treatment of COVID-19 in select patients. Based on current evidence, the role of Baricitinib in treating COVID-19 is limited to patients with severe disease who are on supplemental oxygen and unable to receive or tolerate steroid therapy (dexamethasone). SMH currently has enough available to treat patients admitted with COVID-19 who meet criteria.
Convalescent Plasma — Sarasota Memorial is using convalescent plasma transfusions to treat COVID-19 infections in select patients who are hospitalized. Donated blood plasma from people who have recovered from COVID-19 may contain antibodies to SARS-CoV-2 that 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.
If you or someone you know tested positive for COVID-19 AND have fully recovered from the illness, contact SunCoast Blood Centers to schedule a plasma donation.
Monoclonal Antibody Therapy for High Risk Outpatients — Sarasota Memorial is among a number of hospitals that have been allocated monoclonal antibody therapy for non-hospitalized patients who have been diagnosed with a mild-to-moderate case of COVID-19. To be eligible for monoclonal antibody therapy, patients must have been diagnosed in the previous 10 days and must have a high risk for severe disease or hospitalization. (Click here to learn more.)
Are there any COVID-19 related clinical trials under way at SMH?
SMH has been participating in multi-national clinical trials studying the Regeneron REGN-COV2 Antibody Cocktail's dual-action, monoclonal antibody cocktail for the treatment and prevention of COVID-19.
Regeneron Clinical Trials
For study specifics and eligibility questions on the Regeneron Clinical Trials, call the SMH Clinical Research Center (8am-3pm, Monday-Friday): Call 941-917-2225.
- Inpatient Treatment Trial: SMH is enrolling patients hospitalized with COVID-19 in randomized, placebo-controlled, double-blind clinical trials. Enrollment is time-sensitive. For study specifics and eligibility questions, call the SMH Clinical Research Center at 941-917-2225 (8am-3pm, Monday-Friday).
- Prevention Trial: SMH also is enrolling healthy adults in a randomized, placebo-controlled, double-blind clinical trial testing whether REGN-COV2 can prevent infection by the novel coronavirus that causes COVID-19. Enrollment is time-sensitive. To qualify, participants must have no symptoms and must have been in close contact (typically residing in the same household) with an infected person in a 96-hour window prior to receiving the REGN-CoV-2 antibody treatment or placebo. For more information and eligibility questions, call 941-917-2225.
Do Hydroxychloroquine & Azithromycin Help Patients with COVID-19? Are these Being Used to Treat COVID-19 Patients?
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. 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 treating COVID-19, except in a clinical trial.
There have been multiple studies looking at the potential use of these agents for treating COVID-19. 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 askanexpert@smh.com.
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 last updated Feb. 4, 2021; it was originally posted March 31, 2020, and 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.