Medications and Treatments for COVID-19
LAU’s School of Pharmacy clinical faculty discuss current treatments for COVID-19 and the protocol for researching a new medicine.
Clinical Associate Professor-Pharmacy Practice in Infectious Diseases, Hanine Mansour (PharmD ‘02), and Clinical Assistant Professor-Pharmacy Practice in Critical Care, Yara Mary Kuyumjian (PharmD ‘14) clear up fundamental questions on the pharmaceutical side of COVID-19.
When a patient is diagnosed with COVID-19, what kind of treatment does he/she get at the hospital?
Currently, there is little firm evidence of a single or a combination of medications to treat or cure the 2019 coronavirus disease or COVID-19 that is caused by the novel coronavirus. Depending on the severity of the illness and the patient’s coexisting diseases, the in-hospital treatment of a patient with confirmed COVID-19 can range from supportive and symptomatic treatment to more advanced therapies that target the virus. Globally, there are currently many clinical trials investigating different treatment regimens for COVID-19 including existing medications such as chloroquine and hydroxychloroquine that are typically used for the treatment of malaria and rheumatologic diseases, antiretrovirals for the treatment of HIV/AIDS, the anti-viral agent remdesivir, and the immunosuppressant tocilizumab that targets the over-reactive immune system.
Lately we’ve been hearing on different media channels that there are medications proven effective in the treatment of COVID-19. Is this true?
This is in relation to chloroquine and hydroxychloroquine (a less toxic derivative of chloroquine). What has initially piqued curiosity in considering these two medications for the treatment of COVID-19 is their in vitro (laboratory experiment outside living organism) activity against its causative agent the Severe Acute Respiratory Syndrome Coronavirus 2 or SARS-CoV-2. The media hype around this was further ignited following the results of a small-scale pilot trial in France that used a combination of hydroxychloroquine with or without azithromycin (an antibiotic) in COVID-19 positive patients. A total of 26 patients received hydroxychloroquine alone, and six patients received azithromycin in addition to hydroxychloroquine. The study looked at nasopharyngeal virus clearance, clinical parameters, and side effects. Hydroxychloroquine-treated patients had clearance of the nasopharyngeal virus in 3-6 days.
Furthermore, the same group of investigators followed up with another similar trial on 80 patients. Sixty-five out of 80 patients (81 percent) had favorable outcomes and were discharged from the hospital on day four, one patient died, and treatment was stopped in one patient due to cardiac side effects. Nasopharyngeal tests showed that the majority of patients’ nasopharynx cleared from the virus on day eight, and in all patients on day 12. Although these results are promising, the trial did not have a control arm and there remain concerns regarding the effect of the medications on the overall clearance of the virus. Because small-size trials cannot provide the needed evidence of the newly examined medications, the World Health Organization (WHO) is now conducting a large international clinical trial called SOLIDARITY that is aimed at evaluating the safety and efficacy of the different treatments that may have shown potential benefit in smaller studies.
Therefore, hydroxychloroquine and chloroquine should only be used when properly indicated for COVID-19 patients and under close medical supervision. Also, stockpiling these medicines may lead to their shortage, eventually depriving patients with rheumatoid arthritis, lupus or other conditions for which they have proven benefits. On March 28, 2020, the US Food and Drug Administration (FDA) issued a guidance letter for the emergency use authorization of hydroxychloroquine and chloroquine.
Hence, physicians and pharmacists need to adhere to the highest standards of practice whenever prescribing or dispensing hydroxychloroquine or chloroquine with the intent to stockpile these medications. The public is reminded that these medications are not used to prevent or to self-medicate for COVID-19 and can have serious side effects. They can have psychiatric and heart side effects such as life-threatening irregularities in the heart rhythm, and can also cause a drop in blood sugar levels particularly in diabetic patients. Additionally, azithromycin can negatively affect the heart and more dangerously so when combined with hydroxychloroquine or chloroquine.
In the setting of outbreaks caused by new viruses such as this 2019 novel coronavirus, what are the procedures for researching available medicines that might treat it? Can investigational agents be used on patients with the disease before going through clinical trials?
When considering clinical research during rapidly emerging outbreaks, it is typical that medicinal products that have previously shown promise in the earlier pre-clinical testing stages are pushed to the forefront of clinical trials. As COVID-19 is progressing rapidly, scientists and clinicians have begun to investigate the potential role of antivirals that were still in their earliest stages of development.
For instance, remdesivir is an antiviral that was originally developed for the treatment of Ebola virus disease but has not been labeled by the FDA for such treatment. The potent in vitro antiviral activity of remdesivir has also been demonstrated against the Middle East Respiratory Syndrome (MERS-CoV), SARS-CoV-1 and SARS-CoV-2 (the virus responsible for COVID-19).
Remdesivir’s high selectivity for the virus makes it a potentially safe medication. Although its efficacy and safety have not been proven in large controlled clinical trials, it is now made available by the pharmaceutical manufacturer to clinicians through a compassionate “expanded access process” given its remarkable benefits shown in vitro and laboratory animal models. This process allows access to investigational therapies outside clinical trials when no comparable or satisfactory alternative therapy options are available. However, it is important to note that randomized controlled trials (RCTs) remain the gold standard type of studies to assess the efficacy and safety of medication therapies. Currently, there are ongoing trials investigating the efficacy and safety of remdesivir in COVID-19 patients.
Since a lot of information is coming out these days, some fake and some true, what is the procedure and who is the authority when it comes to announcing new medications/effective treatments to the public?
It is always wise to get information from reliable sources such as the FDA, Centers for Disease Control and Prevention (CDC), European Medicines Agency (EMA), or WHO. In Lebanon, people can check the updates of the Ministry of Public Health webpage. It is also important to discuss medication directions with the treating physician or pharmacist.
Can immunity against the virus be potentially transferred to sick patients from those who have recovered from COVID-19?
Potentially yes, but we do not know yet for how long this immunity lasts in recovered COVID-19 patients. “Convalescent plasma” (plasma is the liquid blood component) is being investigated in seriously ill COVID-19 patients. The blood of a recovered patient from COVID-19 contains specific antibodies to the coronavirus. The antibody-rich plasma after separation from the whole blood is then transfused into a very sick COVID-19 patient to help fight the viral infection.
Convalescent plasma has been explored in other outbreaks such as the 2009-2010 H1N1 influenza, 2003 SARS-CoV-1, 2012 MERS-CoV and 2014 Ebola virus, all of which showed variable outcomes. While awaiting the results of ongoing clinical trials, it is not yet officially recommended to use convalescent plasma in COVID-19 patients. Yet, given the urgent need for therapeutic options, the FDA has a facilitated process for physicians to access and use convalescent plasma in COVID-19 patients with serious or immediately life-threatening disease.
While this novel coronavirus pandemic is rapidly changing, treatment guidelines can also quickly change. Therefore, experts should be regularly consulted on up-to-date recommendations.
This article has been edited and condensed for the sake of clarity. The full version can be accessed on the COVID-19 website.