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Ask Dr. Halverson: COVID-19. The latest information on treatment options

web 4 17 Halverson photo

Dr. Jim Halverson

 

 

By Dr. Jim Halverson
More than 11 million people worldwide, including more than 3 million in the United States, have tested positive for the novel coronavirus and that number is growing quickly. Our healthcare system is becoming increasingly strained and we are in desperate need of a safe and effective treatment for COVID-19. Hospitals and research labs all over the world are testing many different therapies on coronavirus positive patients in an effort to find a potential treatment. Here is what we know so far about emerging treatments for this highly contagious and potentially lethal virus.

   1) REMDESIVIR

Remdesivir is an antiviral drug that is given by intravenous infusion in the hospital. This is a brand-new drug that has not been approved by the Food and Drug Administration for use on the market yet and is being tested in carefully controlled environments. Early results from a large study of 1,063 patients showed that hospitalized patients who got remdesivir recovered faster than those who got a placebo (11 days vs. 15 days, respectively). The death rate in the remdesivir group (7%) was also lower than that of the placebo group (12%). Patients who needed oxygen saw the most benefit. While these early findings support the use of remdesivir for patients with COVID-19, the researchers concluded that treatment with remdesivir alone is likely not enough because those who got the medication still experienced a high death rate. 
Nonetheless, based on this study, the early results of another phase 3 trial in hospitalized patients with severe symptoms, and a small study in patients who received remdesivir through a compassionate-use program, the FDA issued an emergency use authorization for remdesivir on May 1. The emergency use authorization does not mean that the FDA has approved remdesivir for the treatment of COVID-19. Rather, the intent of the emergency use authorization is to make it easier for doctors to get remdesivir for hospitalized patients with severe symptoms.

    2) DEXAMETHASONE

Dexamethasone is a common corticosteroid medication that has been used for many years to treat various health conditions, such as autoimmune conditions and allergic reactions. RECOVERY, a randomized clinical trial in the United Kingdom, is studying many medications, including dexamethasone, to see if any are effective against COVID-19.
A press release from RECOVERY reported there was a lower death rate in the 2,104 hospitalized patients with COVID-19 who got a low daily dose of dexamethasone (either by mouth or IV injection) compared to the 4,321 patients who did not get it. The medication seemed to be the most helpful for patients who were either on a ventilator (35% lower death rate) or needed extra oxygen (20% lower death rate); there was no benefit for those with less-severe symptoms.

    3) HYDROXYCHLOQUINE

This past week, Henry Ford Health System in Detroit published a large-scale retrospective analysis of 2,541 patients hospitalized between March 10 and May 2 across the system’s six hospitals. The study found that 13% of those treated with hydroxychloroquine alone died compared to 26.4% of those not treated with hydroxychloroquine. None of the patients had documented serious heart abnormalities.
Patients treated with hydroxychloroquine met specific protocol criteria as outlined by the hospital system’s Division of Infectious Diseases. The vast majority received the drug soon after admission; 82% within 24 hours and 91% within 48 hours of admission. All patients in the study were 18 or over with a median age of 64 years; 51% were men and 56% African-American.
The findings were highly analyzed and peer reviewed. Lead co-authors, Dr. Marcus Zervos and Dr. Samia Arshad, attributed the findings, which differ from other studies that found hydroxychloroquine ineffective, to early treatment, and enhanced inpatient supportive care treatment, including careful cardiac monitoring.
Dr. Zervos pointed out, as did the paper, that the study results should be interpreted with caution, should not be applied to patients treated outside of hospital settings and require further confirmation in prospective, randomized clinical trials that rigorously evaluate the safety and efficacy of hydroxychloroquine therapy for COVID-19. “Currently, the drug should be used only in hospitalized patients with appropriate monitoring, and as part of study protocols, in accordance with all relevant federal regulations,” Dr. Zervos said.

    4) AZITHROMYCIN

Azithromycin (informally know as a Z-pak) is an antibiotic commonly used to treat bacterial infections such as bronchitis and pneumonia. One research group looked at azithromycin in combination with hydroxychloroquine for COVID-19. They reported that 93% of patients cleared the virus after 8 days, but there was no control group so we don’t know if people would have cleared the virus on their own without the medications. There are concerns about potentially serious side effects when using azithromycin and hydroxychloroquine together.

    5) CONVALESCENT PLASMA 

On March 24, the FDA issued an Emergency Investigational New Drug application for the use of convalescent plasma to treat people with COVID-19. Plasma is the liquid part of the blood that carries blood cells. Convalescent plasma is collected from people who have recovered from COVID-19. It is then transfused into someone with an active coronavirus infection. It is thought that the antibodies found in the convalescent plasma can help fight the coronavirus infection.  An estimated 25,000 patients have already been transfused in the United States.
The research so far has shown convalescent plasma to be safe. Doctors have reported anecdotal success, but clinical trials to determine whether convalescent plasma is indeed effective are ongoing. 

    6) TOCILIZUMAB (Actemra)

Tocilizumab is a disease-modifying anti-rheumatic drug approved for rheumatoid arthritis. It works by blocking interleukin-6 (IL-6), a protein involved in our natural immune responses. One of the issues with COVID-19 is its potential to over-activate our immune system. This over-activation may cause a cytokine storm, a potentially fatal problem in which the immune system goes haywire and inflammation gets out of control. A study from France reported that people who got the drug were less likely to require ventilation or die. Another study in Italy reported a lower death rate. Other studies on this and other medications that affect the body’s immune response are ongoing.

    7) ANTIVIRALS 

In addition to remdesivir, several other antivirals, including oseltamivir (Tamiflu), which is used to treat influenza, are currently being studied.
    8) COLCRYS (colchicine)
Colchicine is a medication used for gout. It works in many different ways, including activating anti-inflammatory processes and interfering with cells involved in inflammation. Researchers believe that colchicine could be used to prevent or decrease a cytokine storm. A large clinical trial is currently seeing if colchicine, when given soon after a COVID-19 diagnosis, can lower the chances of hospitalization and death.

       CONCLUSION

There are currently no FDA-approved treatments for coronavirus. The FDA recently created a new emergency program, Coronavirus Treatment Acceleration Program, aimed at speeding up research for the development of COVID-19 treatments. This huge international effort will eventually lead to a medication, or combination of medications, that will treat COVID-19 safely and effectively.
For now, the treatment for patients with mild symptoms is to self-isolate at home. Patients who are hospitalized receive supportive care (such as oxygen), possibly enroll in clinical trials, and are given medications, such as those listed in this article, based on hospital guidelines and their doctors’ clinical judgement. All of our local hospitals have developed those clinical guidelines. 
Stay optimistic, stay committed, stay safe and stay well.

 

— Dr. Jim Halverson is a longtime Ojai physician who writes a weekly column on COVID-19 for the Ojai Valley News.