News concerning proposed COVID treatments can be confusing. The efficacy and safety of these medications are scientifically debatable. This is of particular importance in light of the new Omicron variant and almost certain future variants.
The internet is full of stories and claims surrounding possible preventatives and COVID treatments. Medications of particular note are ivermectin, hydroxychloroquine, fenofibrate, azithromycin, cyproheptadine, dutasteride, montelukast, and prednisone.
A Word of Caution
The only currently approved Federal Drug Administration (FDA) prevention and/or treatments are COVID-19 vaccines by Pfizer-BioNTech, Moderna, and Johnson & Johnson, plus Remdesivir.
However, under certain circumstances, the FDA has approved the emergency use of tocilizumab, sotromivab, Propofol-Lipuro, bamlaniyimab, etesevimab, casirivimab, imdevimab, baricitinib, COVID-19 convalescent plasma, REGIOCIT replacement solution, Fresenius Kabi Propoven, and the Fresenius Medical multifiltrate PRO System and multiBic/multiPlus Solutions.
None of the other medications discussed in this article are approved by the Food and Drug Administration for the prevention or treatment of COVID-19. This article makes no claim that any of these drugs are effective against the COVID-19 virus. Rather, this is a candid discussion about what is known about these potentially useful medications.
These drugs may show promise but require more extensive investigation and testing. They are prescription medications and are not be confused with over-the-counter vitamins and supplements. Proceed with caution with all medical treatments and seek professional medical advice.
Ivermectin for COVID Treatment
Ivermectin is an anti-parasitic drug. It is important to note that there are two available versions of ivermectin. One is approved by the FDA for human use, while the other is restricted to veterinary use.
Ivermectin for human use comes in a commercially available tablet and in a powder that can be compounded into capsules of the desired strength. Ivermectin for veterinarian use typically comes in a paste or in a powder that can be compounded into various dosage forms.
Ivermectin for veterinary use may have impurities or exceed the maximum level of impurities permitted for human use. Many patients are being prescribed Ivermectin for off-label use for COVID-19.
As an example:
Prophylaxis: 12mg and up weekly based on body weight.
Treatment: 12mg and up daily x 5 days based on body weight.
Both the FDA and the Centers for Disease Control and Prevention have issued warnings about its unauthorized use. Ivermectin for veterinary use is generally available in a much bigger dose to treat large animals such as horses that can weigh as much as 1,000 lbs.
Some individuals attempting to self-medicate with ivermectin for veterinary use have ended up in the hospital. Additionally, ivermectin interactions with other medications such as blood thinners are of concern. Overdosing can result in nausea, vomiting, altered mental status, blurred vision, and in severe cases, even seizures and death.
Hydroxychloroquine is a medicine used to prevent and treat malaria. It’s also used to treat rheumatoid arthritis and lupus. Many patients are being prescribed hydroxychloroquine for off-label use for COVID-19.
As an example:
Prophylaxis: 400mg twice or three times weekly
Treatment: 200mg – 600mg immediately on diagnosis, then 400mg in 12 hrs, then 200mg twice daily x 5 days, then 200mg daily x 5 days
Early in the pandemic, hydroxychloroquine received emergency use authorization (EUA) from the FDA for some hospitalized COVID-19 patients.
However, the FDA revoked the EUA in June 2020 after a clinical trial showed that hydroxychloroquine had no positive effect on shortening hospital stays or reducing the likelihood of death. A revocation of an EUA indicates that the known risks of a drug outweigh the known benefits.
There are numerous reports of COVID-19 patients who received hydroxychloroquine experiencing abnormal heart rhythms. Heart issues include ventricular tachycardia, which is a life-threatening rapid heart rate. Patients with pre-existing heart issues may be at an increased risk.
Anecdotal reports suggest that hydroxychloroquine may be of benefit as a preventative. It may also be effective during the early stages of COVID-19 but worsen outcomes if used in patients requiring hospitalization in the later stages of the illness.
Fenofibrate is a drug that helps lower cholesterol and reduces the level of triglycerides or fatty acids in the blood. Fenofibrate is of particular interest as it is a low-cost, well-established, and widely available prescription. Some patients are being prescribed fenofibrate for off-label use for COVID-19.
As an example:
Treatment: 160 – 200mg daily x 10 days
Fenofibrate’s possible use for COVID-19 first came to the world’s attention after researchers in Israel led by Prof. Yaakov Nahmias of Hebrew University reported that it showed promise in the laboratory against infected cells.
Then, those same researchers in Israel reported that a group of 14 out of 15 COVID-19 patients on oxygen no longer needed oxygen support after one week of using fenofibrate. All 15 survived and left the hospital.
Those early reports spurred other doctors, such as Dr. Julio A. Chirinos at the University of Pennsylvania, to begin additional research studies. However, none of the research teams have produced conclusive findings to date.
In part, they’re looking to see how fenofibrate appears to halt the cellular degeneration of the lungs. COVID-19 belongs to a group of viruses identified by their ability to produce severe and acute respiratory issues.
The lung cells of COVID-19 patients have shown high production of fatty acids. Fatty acids are what fenofibrate reduces in high-cholesterol patients.
There are also indications that fenofibrate may interfere with the ability of the COVID-19 virus to lock onto cells and reproduce. If so, the drug would slow the infection, giving the body’s natural immune system a better chance to fight the invasion.
Azithromycin is a commonly used antibiotic that treats bacterial infections, including pneumonia. In addition to its antibacterial properties, azithromycin also has antiviral abilities. Furthermore, it also works as an anti-inflammatory.
Naturally, its treatment range has caught the attention of those looking for ways to combat COVID-19. Some patients are being prescribed azithromycin for off-label use for COVID-19.
As an example:
Treatment: 250mg – 500mg daily x 5 days – Often in conjunction with hydroxychloroquine or ivermectin
A study examining the effectiveness of azithromycin against COVID-19 took place in Northern Italy, in the city of Brescia in the Lombardy region. The 2020 study used 1400 patients of Fondazione Poliambulanza, a city hospital.
According to the findings of the study, azithromycin severely reduced the mortality rate among patients. Only 16% of the patients who received doses of azithromycin died while in the hospital. Investigators speculate that the drug’s ability to inhibit the growth of bacteria disrupted COVID-19’s replication process.
The study was led by Filippo Albani of Fondazione Poliambulanza Istituto Ospedaliero. In contrast, a similar hospital study saw no significant evidence of the effectiveness of azithromycin against COVID-19.
The study, led by Eli S. Rosenberg, Ph.D., involved patients from 25 New York City-area hospitals. The results were published in the May 2020 edition of The Journal of the American Medical Association.
One of the primary reasons that azithromycin is not routinely used against COVID-10 despite its antiviral properties is because of the risk it poses to the heart, possibly extending the time between the stages of a heartbeat, resulting in an irregular heart rhythm.
Cyproheptadine is an antihistamine. Like the more common antihistamines that you purchase over-the-counter, cyproheptadine reduces the symptoms caused by an overproduction of histamine. Some patients are being prescribed cyproheptadine for off-label use for COVID-19.
As an example:
Treatment: 4mg daily
An investigation under the direction of Dr. Philip Keith of Critical Care Medicine, Lexington Medical Center, West Columbia, South Carolina, looked at the effectiveness of cyproheptadine against serotonin syndrome in two COVID-19 cases.
Serotonin toxicity occurs when the body produces too much serotonin. The condition, known as serotonin syndrome, is marked by an altered mental state, such as delirium.
Serotonin toxicity is thought by the investigators to possibly play a notable role in the death rate of COVID-19 sufferers. In both cases cited by the investigators, the patients rapidly recovered mental stability after undergoing steady treatments of cyproheptadine.
Doctors have long discussed the possible role of histamine in the development of lung complications among COVID-19 patients. However, the medical community is still waiting for a conclusive clinical trial that points to cyproheptadine as a definite effective fighter against the complications of COVID-19.
Reports indicate that there were 2021 plans for such a study announced by CIUSS de l’Est-de-I’lle-de-Montreal.
Dutasteride inhibits testosterone from converting to dihydrotestosterone which is a significantly stronger hormone. Some patients are being prescribed dutasteride for off-label use for COVID-19.
As an example:
Treatment: 0.5mg daily x 30 days or until COVID-19 symptoms resolve
A study led by Flavio A. Cadegiani, Internal Medicine: Diabetes and Endocrinology, Applied Biology Inc., Irvine, CA, and Clinical Endocrinology, Federal University of Sao Paulo, Sao Paulo, Brazil, looked at the effectiveness of dutasteride to lessen the symptoms of COVID-19.
The principal site was Corpometria Institute, Brasilia, Brazil. The study used patients in the Brazilian healthcare system.
Doctors have noted that COVID-19 can be more dangerous to some men due to the virus using male hormones to facilitate its spread throughout the body. Dutasteride prevents the formation of excess male hormones, so doctors have experimented with using the drug to reduce the severity of COVID-19 related symptoms.
The study found that patients who took dutasteride recovered faster than those who didn’t. After one week, only 15.9% of those taking dutasteride were still showing symptoms, compared to 42.5% of those taking the placebo.
This study specifically focused on the initial period of contracting COVID-19 when dutasteride treatment is believed to be the most effective. The majority of research surrounding possible drugs that can be used against COVID-19 is centered around the later, more severe stages of the virus.
Montelukast is a mast cell stabilizer most often used for the treatment of asthma and allergic rhinitis. Some patients are being prescribed montelukast for off-label use for COVID-19.
As an example:
Treatment: 10mg daily
Dr. Ahasan R. Khan of the Rutgers Cancer Institute of New Jersey at Rutgers University led a study that examined the effect of montelukast on hospital patients with COVID-19. The objective was to see if the mechanisms that make montelukast effective against asthma and allergic rhinitis would reduce the severity of respiratory distress caused by COVID-19.
The study conducted a retrospective analysis using 92 patients. Thirty received montelukast, while 62 did not.
Investigators concluded that montelukast was successful at reducing the patient’s deterioration. While the conclusion was optimistic, the researchers noted that their theory needs further testing through additional studies.
Prednisone is a corticosteroid that works by suppressing the body’s immune system to decrease inflammation. Doctors often prescribe it for lupus, skin conditions, breathing issues, and arthritis. Many patients are being prescribed prednisone for off-label use for COVID-19.
As an example:
Treatment: 20mg – 40mg daily
The National Institutes of Health (NIH) reports that there are both positive and negative reports associated with the use of corticosteroids, specifically, prednisone, in the treatment of lung infections. The drug appeared to help some pneumonia patients but seemed to worsen the outcome for those with severe cases of pneumonia.
NIH recommends the use of corticosteroids in a hospital setting but still suggests discretion rather than routine use. There are no NIH recommendations for at-home use of corticosteroids, such as prednisone for the fight against COVID-19.
NIH recommendations are based on the collective findings of clinical trials conducted in several countries, including China, South Korea, Iran, Germany, Japan, and India.
Access to Medication and Customization for Special Needs
Many of these medications are in high demand leading to major shortages and backorders. Other medications are not available in the strengths needed.
These medications require not only a prescription, but sometimes they also need a compounding pharmacy’s unique services. For example, there are instances when individuals cannot tolerate dyes and other inactive ingredients found in many commercially available medications.
Let us use our experience to help you resolve your medication challenges. Contact us today to discover the full range of our services.