Finding a way to effectively treat and immunize COVID-19  is the number 1 priority for most countries during this pandemic. Globally there have been over 2 million COVID cases with thousands of deaths everyday.  The World Health Organization (WHO) has put together an unprecedented global trial called SOLIDARITY to evaluate treatment options for COVID-19. The strategy is to re-purpose current medications on the market and determine if they can treat the virus.  This is only a band-aid solution until a vaccine can be developed to cure the disease. This article will discuss some of treatment options being tested and then provide information on the COVID-19 vaccine development timeline.

Treatment Options

Chloroquine/Hydroxychloroquine and Azithromycin 

WHO originally had not intended to study chloroquine or hydroxychloroquine. However, since Donald Trump felt they were “game changers” and put the media into a frenzy, WHO changed their decision and included the medication in the SOLIDARITY trial. 

Chloroquine is as an antiparasitic medication used to prevent a malaria infection. Hydroxychloroquine is most commonly used to treat rheumatoid arthritis and systemic erythematosus lupus (SLE). Both medications most common side effect is stomach upset.    

At first glance these medications would not be effective COVID-19 treatments, but there is some interesting evidence to suggest that they may work. Chloroquine/hydroxychloroquine may reduce the capacity for viruses to enter human cells, which would limit the number of healthy cells getting infected.  It may also interfere with how viruses make their proteins, making it difficult for the viruses to replicate. 

The SOLIDATIRY trial doesn’t include at Azithromycin, but Donald Trump did tweet about how great it was alongside hydroxychloroquine. Which is why it has also garnered so much media attention. 

Azithromycin is a macrolide antibiotic designed to kill bacteria; however, there is some data to suggest it has anti-inflammatory and anti-viral capabilities by modulating the immune system. This was seen in patients with Chronic Obstructive Pulmonary Disease (COPD) who took Azithromycin while infected with the rhinovirus. This study showed that Azithromycin may be effective for viral infections.

A French study showed that both hydroxychloroquine and azithromycin might be effective COVID-19 treatment. Interestingly, the results suggested that azithromycin can work together with hydroxychloroquine for an even stronger effect. 

In the study 57.1% of patients treated with hydroxychloroquine were cured (didn’t have any virus detected in their nasal swab test) by day 6 of treatment. This was significantly higher compared to the 12.5% of cured patients with no treatment. However, the patients that received azithromycin and hydroxychloroquine together had a 100% cure rate by day 6. 

These results are promising but it is important to know that the study only contained 36 people. The sample size is too small to draw any meaningful conclusions because small samples are unreliable.

In addition, the study doesn’t mention is that Hydroxychloroquine/chloroquine and azithromycin can affect heart function.  If may be unsafe for patients with hearth arrhythmias to take both medications together.

Kaletra – Lopinavir/Ritonavir

Kaletra is a medication developed to treat the human immunodeficiency virus (HIV).  It is a combination pill with Lopinavir and Ritonavir. Ritonavir interacts with Lopinavir to boost its levels in the body, making it an effective antiviral. Kaletra is generally dosed twice daily and its most common side effect is diarrhea.

Kaletra has been found to have activity against other Corona viruses such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). However, Kaletra’s clinical effectiveness for COVID-19 is currently unclear. 

The result from a COVID-19 study run in China, “A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19” was not optimistic.  The study showed that there was no difference between patients given Kaletra and standard care.  However, the researchers state that it may be due to patients receiving treatment too late; 20% of patients died in the study of 199 participants. The study may have only proven that it is ineffective to treat COVID-19 too late.

Remdesivir

Remdesivir was originally developed to treat the ebola virus epidemic that occurred in Africa. However, it was not effective enough to be considered a viable option compared to other treatments for ebola, so it was shelved. Luckily there were a few studies that showed it can be effective for Corona viruses like SARS and MERS. Therefore, WHO decided to include it in the SOLIDARITY trial to verify if it can treat COVID-19.

Remdesivir is a broad-spectrum antiviral drug dosed once daily. Unlike many of the other COVID-19 treatment candidates, it is not a tablet or capsule but requires a nurse to inject it intravenously into the arm.  This will make if more difficult to administer the medication to patients because they will have to be in hospital to receive treatment.

The manufacturer of Remdesivir, Gilead, recently released preliminary data showing COVID-19 treatment results. It reported that 36 of the 53 patients who received Remdesivir showed clinical improvement by day 18.  However, this study did not compare against patients who did not receive Remdesivir. It is unclear if patients who received Remdesivir did better or worse compared to patients who received regular care.   

Conclusion – SOLIDARITY Trial

A large study like the SOLIDARITY trial will help evaluate the safety and effectiveness of these medications so that we will be better equipped to handle this pandemic.  Once the vaccine for COVID-19 is developed, these treatments will become less important because the population will have immunity.

Vaccine/Drug Development Timeline

There are currently 70 vaccines in development for COVID-19.  Only 3 of these are in the clinical testing phase.  Clinical testing is when pharmaceutical companies can test i.e animal and humans.

In pharmaceutical development there are 4 main phases of testing before the drug/vaccine can be brought to market.  These are:

1. Preclinical: This is when lab and animal tests are conducted.  The information from these tests help estimate a safe dose in humans.
2. Phase 1: This is a small study of 20 to 80 volunteers. These tests are to evaluate side effects of the medication and the maximum tolerated dose. This phase lasts a few months
3. Phase 2: This is a larger study with 50 to 300 patients. Researchers evaluate effectiveness of the new drug, the most effective dose, toxicity and medication interactions.  This phase lasts several months up to 2 years.
4. Phase 3: This is the largest study with 300 to 3000 patients. This study is designed to assess quality of life, efficacy, and safety of the drug. This phase can last years.

When will there be a COVID-19 vaccine?

It’s estimated to take 12 to 18 months before a vaccine is on the market.  This is incredibly fast compared to standard vaccine development which can take over a decade. Until then social distancing and hygiene will be important to prevent the spread of COVID-19.

For more information about COVID-19, check out our other article – 5 Thing You Should Know About COVID-19