Coronavirus (COVID-19) Update: Warnings on Potential Treatments

Coronavirus (COVID-19) Update: Warnings on Potential Treatments

You may have heard that there are some medications that might treat coronavirus (COVID-19). Among these potential treatments are drugs called remdesivir, famotidine, ivermectin, Actemra, chloroquine (chloroquine phosphate), and hydroxychloroquine. This is based on small, preliminary reports on their use. There are risks associated with these medications and they should not be taken or obtained without a prescription. Read details about each potential treatment below.

Is there a vaccine for coronavirus (COVID-19)?

According to the CDC, there is currently no approved vaccine to prevent COVID-19. Don’t let that discourage you: scientific research and clinical trials are ongoing all around the world to help deliver a safe and effective vaccine as soon as possible. A vaccine could take 12-18 months before it’s approved for the public, but new data indicates we could see one sooner than that. Moderna, manufacturer of the first COVID-19 vaccine clinically tested in eight humans, reported the vaccine appears to be safe so far — they were able to create COVID-19 antibodies in the trial participants. Moderna’s clinical trial is still in the first phase, but they are moving forward on an accelerated timetable with plans to start testing in 600 humans during the second phase of the trial. If that goes well, the third phase could include testing in thousands of healthy people. More data is needed before we see a vaccine safe for the public.

Can I test for COVID-19 at home?

(Soon Antibody Test Kit will be authorized for use at Clinic or home)

On May 16th, 2020, the FDA issued an emergency use authorization for the Everlywell, Inc COVID-19 Test Home Collection Kit. The kit can be used by people who are first screened via an online questionnaire that is then reviewed by their health care provider. With this authorization, people are able to collect a nasal sample in their own home. The risk of spread is reduced further by the availability of overnight shipping of the sample to a certified lab for testing. The test kit should be available to the public by the end of the month! Check https://www.everlywell.com for more information.

Can favipiravir treat coronavirus (COVID-19)?

The Russian Ministry of Health has approved the use of an antiviral flu drug called favipiravir to treat coronavirus. Favipiravir has shown promise in early testing in hospitalized patients taking the drug that were able to recover from coronavirus faster. In a randomized control trial of 40 coronavirus patients, 65% tested negative within five days, which is about half the time it took the untreated group. Favipiravir comes in a pill form, making it easier to administer than an intravenous medication like remdesivir. This information out of Russia provides hope, but more data is needed before we see widespread use of this drug. Research on favipiravir is ongoing in Japan, China, and the U.S. It is important to note that the safety and efficacy of favipiravir to treat coronavirus has not been declared by the FDA at this time.

Can remdesivir treat coronavirus (COVID-19)?

Remdesivir has shown in a clinical trial to decrease recovery time in some COVID-19 patients. On May 1st, 2020 the FDA issued an emergency use authorization for the use of remdesivir in treating COVID-19 in hospitalized adults and children with severe disease. The World Health Organization has launched a multi-country initiative to test medicines already on the market to find ones that best treat COVID-19. According to reporting in Stat News, in addition to chloroquine, three other drugs will be assessed: “the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta.” However, a study in China has reported no benefit with lopinavir and ritonavir.
Previously, FDA Commissioner Stephen Hahn had deemed remdesivir available for “compassionate use” by patients that have tested positive for COVID-19. In fact, it was given for “compassionate use” to the first U.S. patient confirmed to be infected with coronavirus. No adverse events were observed in association with its infusion.
Remdesivir, manufactured by Gilead Sciences, is an antiviral drug that was used to treat the Ebola virus and Marburg virus. The drug’s efficacy as a treatment for COVID-19 is still being studied, but because some medical experts believe it may work, it has been administered to some COVID-19 patients in China, Italy, the Czech Republic, and the United States. Gilead Sciences had temporarily put emergency access to remdesivir on hold due to overwhelming demand.
Gilead Sciences applied to the FDA for the approval of remdesivir as a treatment of COVID-19 under the Orphan Drug Act. An orphan drug status permits drug companies to prevent a lower cost generic version from coming to market for a longer period of time. Likely in response to criticism from drug affordability activists, Gilead Sciences asked the FDA to cancel the drug’s orphan drug status.
Gilead Sciences has started two phase 3 trials of remdesivir for evaluation of safety and efficacy in adult COVID-19 treatment in the U.S. The information gathered from these trials will be vital for us to understand how this drug can combat COVID-19.

Can chloroquine or hydroxychloroquine treat coronavirus (COVID-19)?

To date, neither form of chloroquine has been approved by drug regulatory authorities for the treatment of COVID-19 (with the exception of Poland where chloroquine phosphate is approved for this use) but the FDA has issued an emergency use authorization for hydroxychloroquine and chloroquine drug products for certain patients.
The Latest: The World Health Organization (WHO) announced they have temporarily suspended the use of hydroxychloroquine in their Solidarity trial for potential COVID-19 treatments. The WHO decided to remove hydroxychloroquine after a recent study published indicated a lower survival rate for hospitalized COVID-19 patients taking hydroxychloroquine. They will continue to review the potential risks and benefits of this drug during the suspension of use.
Laboratory studies indicate chloroquine may be effective in reducing the replication of SARS-CoV-2 (the virus that causes COVID-19). China has added chloroquine as an option to treat patients in their Novel Coronavirus Pneumonia Diagnosis and Treatment Plan. Note: The original source is written in Chinese. Here is an unofficial english translated version.
A small study in France involved giving a small number of COVID-19 patients 200 mg of hydroxychloroquine three times daily. It found that the medication reduced the percentage of patients shedding the virus within six days as compared to patients not given the medication. Adding azithromycin to the treatment regimen appeared to further reduce viral shedding. However, the effect of these treatments on patient outcomes, particularly survival, has not yet been reported. (Be aware that the combination of azithromycin and chloroquine phosphate may increase your risk of an irregular heartbeat, which can be life-threatening.) On the other hand, a small study in China using 400 mg of hydroxychloroquine once daily did not show a reduction in viral shedding (Chen, Zhejiang Uni Journ 2020). A large study of hydroxychloroquine for COVID-19 is now underway in New York City in which two 200 mg tablets are taken twice on the first day and one 200 mg tablet is taken twice on days two to five of the study — this study will take one year to complete.
FDA Commissioner Stephen Hahn has deemed chloroquine available for “compassionate use” by patients that have tested positive for COVID-19.
On March 28th, 2020 the FDA announced an emergency use authorization to allow hydroxychloroquine and chloroquine drug products to be donated to the Strategic National Stockpile and be used on hospitalized adult and adolescent patients with COVID-19 that weigh over 50kg when a clinical trial is not available or feasible.
The U.S. FDA is in early stages of evaluating if chloroquine or hydroxychloroquine are safe and effective to treat COVID-19. A study of hydroxychloroquine is also planned in Australia.
On April 21st, 2020 The National Institute of Health (NIH) announced treatment guidelines for COVID-19. These guidelines will be updated as new clinical data develops. The NIH has recommended not to use azithromycin with hydroxychloroquine for COVID-19 treatment outside of clinical trials because of the potential risk of heart problems. The NIH has also stated there isn’t enough clinical data to advise to recommend either using or not using chloroquine or hydroxychloroquine alone in the treatment of COVID-19.

Can famotidine treat coronavirus (COVID-19)?

Over-the-counter famotidine — otherwise known as brand name Pepcid — is used to help treat heartburn, acid reflux and stomach ulcers. There is an ongoing study out of New York to learn if the prescription version of famotidine at nine times the normal dose may be effective in treating critical COVID-19 patients. Half the patients in the study will be given famotidine with hydroxychloroquine and the other half will be a placebo group. Reports out of China suggest famotidine may bind to an enzyme that could prevent the virus from replicating, however clinical data isn’t available yet. With that said, remember the drug is being tested at a much higher dose than what’s found over the counter, so no need to rush to your local pharmacy to stock up on famotidine unless you actually need it for heartburn. It is important to note that the safety and efficacy of famotidine to treat coronavirus has not been declared by the FDA at this time.

Convalescent Plasma and COVID-19

On March 24th, 2020, the FDA announced they are allowing medical professionals to make emergency use of investigational COVID-19 convalescent plasma. Convalescent plasma essentially means providers will test blood plasma in patients that have recovered from coronavirus for antibodies. They will then inject that plasma (or a form of it) into patients who have serious or life-threatening COVID-19 infections. It is important to note that the safety and efficacy of this method has not been declared by the FDA at this time.

Can ivermectin treat coronavirus (COVID-19)?

Ivermectin is an anti-parasite drug that is used to treat a roundworm infection called threadworm. It is also sometimes used to treat head lice, scabies and other parasite infections. A recent online report in the Antiviral Research Journal indicates that ivermectin quickly prevented SARS-CoV-2 from replicating. The study is still considered “pre-proof,” meaning it is not finalized for publication yet. However, researchers have suggested ivermectin may kill the COVID-19 virus within 48 hours in a petri dish. This data from the lab, although hopeful, would still need to be proven in human studies. It is important to note that the safety and efficacy of ivermectin to treat coronavirus has not been declared by the FDA at this time.

Can Actemra treat coronavirus (COVID-19)?

In some severe cases of COVID-19, there is an overreaction from the immune system that causes the lungs to fill up with immune cells resulting in what is called a cytokine storm. This storm can lead to death. Some severe-case patients have shown high levels of a protein that cause inflammation in the body called interleukin-6 (IL-6). There is a drug that blocks this IL-6 protein, called Actemra or Roactemra (tocilizumab), which has had promising results against COVID-19 in China. Roche, the manufacturer of Actemra, has started a phase III randomized clinical trial to evaluate the safety and efficacy in adult patients with severe COVID-19 pneumonia. It is important to note that the safety and efficacy of Actemra to treat coronavirus has not been declared by the FDA at this time.

Coronavirus Unknowns

It is important for consumers to understand there is still a lot we do not know about drugs currently being evaluated for the treatment of COVID-19. Ongoing and planned clinical trials will allow us to see if any of these drugs will improve aspects of the disease, such as the duration of viral shedding, ventilator usage, the amount of time a patient is hospitalized, and the risk of death. Use of treatments for COVID-19 remains experimental for now. While these treatments are not approved yet, there has been an increase in therapeutic strategies by health care systems. We will update you once they are backed with clinical evidence.
Remember: It is important to not provide false hope, but hope based on facts on COVID-19. Keep up with the facts from the CDC, FDA and WHO.