The novel coronavirus is sweeping across the globe and straining health care systems in almost every country. The usual clinical trial process for developing treatments will not suffice for a virus such as this.
We need treatments developed quickly to prevent further spread of the virus. This is why researchers and administrative bodies all over the world are adapting to repurpose drugs and conduct clinical trials at record speeds.
In addition to drug repurposing, researchers must immediately start de novo drug discovery and phase 1 clinical trials for COVID-19 treatments. This is because there is a limited number of drug repurposing candidates, and there is no guarantee they will work.
Many have argued, including Elon Musk, that we need to ramp up the production of ventilators because there may be a shortage. Musk recently tweeted,
Giga New York will reopen for ventilator production as soon as humanly possible. We will do anything in our power to help the citizens of New York.
? Elon Musk (@elonmusk) March 25, 2020
However, ventilators are not the final answer to fighting COVID-19. Only 30% of patients who go on a ventilator survive for more than a year. They are a last resort that can often save lives. Having an open ventilator for someone to use is better than not having one, but it is more important to prevent patients from getting so sick that they need a ventilator.
To do this, we need treatments for COVID-19, and we need them fast.
Steps for Approval of New Drugs
First, we must give an overview of how drugs get approved for use with humans. Here is an infographic of the steps for drug approval in Canada:
The infographic clearly shows that it is a lengthy process to get new drugs approved. Safety is the main factor regulators look for in the early stages of drug approval.
There are no shortcuts to this. Many studies and clinical trials need to be done with an increasing number of participants to prevent giving a harmful drug en masse to patients. According to the infographic, it can take 9-15 years from drug discovery to approval and marketing authorization.
Repurposing vs. Developing New Drugs
When a new illness is discovered, there are two ways to develop treatments for the condition – drug repurposing and developing novel drugs.
Drug repurposing is the strategy of adapting drugs already approved for use on humans and using them to treat different conditions from the one(s) they were originally developed to treat. Sometimes this involves using only one approved drug for the new ailment, but more often it involves using multiple drugs together as a ?cocktail?.
Novel drug development has the extra burden of proving that the drugs are safe on humans before being able to test for effectiveness. As mentioned, this is a lengthy process because it is paramount to ensure that a drug does no harm to humans before it is given to large numbers of people.
Drug repurposing has the benefit of fast turnaround time since the drug has already been discovered previously and doctors can use it for a new treatment sooner. This quick development is necessary for a pandemic such as COVID-19 because large numbers of people can get sick in such a short time.
The bottom line is, treatments are necessary for preventing the need for ventilation, health care over-burdening, and mortality. To do this quickly, experts are needed who have experience in planning and implementing clinical trials.
COVID-19 Treatments in Development
The list of treatments currently being repurposed and in clinical development for the treatment of COVID-19 is long. See the table below:
|Drug or cocktail||Originator company|
|ASC09/ritonavir, lopinavir/ritonavir, with or without umifenovir||Ascletis, AbbVie, Pharmstandard|
|ASC09/oseltamivir, ritonavir/oseltamivir, oseltamivir||Ascletis, Gilead, AbbVie|
|Azvudine||Zhengzhou Granlen PharmaTech|
|Various combinations of baloxavir marboxil/favipiravir and lopinavir/ritonavir||Shionogi, Toyama Chemical|
|Various combinations of darunavir/cobicistat alone or with lopinavir/ritonavir and thymosin ?1||Janssen, Gilead|
|Chloroquine or hydroxychloroquine||Shanghai Zhongxi Pharmaceutical, Shanghai Ziyuan Pharmaceutical, Wuhan Wuyao Pharmaceutical|
|Interferon alfa-2b alone or in combination with lopinavir/ritonavir and ribavirin||Biogen, Merck|
|Camrelizumab and thymosin||Incyte, Shanghai Hengrui Pharmaceutical|
|Tocilizumab||Chugai Pharmaceutical, Zhejiang Hisun Pharmaceutical, Jiangsu Qyun Bio-Pharmaceutical|
Now we?ll give a quick overview of the main candidates for drugs, cocktails or therapies that can be repurposed to fight COVID-19.
Promising COVID-19 Drugs and Therapies
Hydroxychloriquine – azithromycin
Donald Trump made news by tweeting out that Hydroxychloriquine, a malaria antiviral, and azithromycin, an antibiotic, have strong potential in treating COVID-19. Unfortunately, there is a lack of quality evidence about their effectiveness thus far, but they are being studied further.
The World Health Organization (WHO) is studying chloroquine as well, and a new study is being developed by researchers with the Population Health Research Institute (PHRI), McMaster University and Hamilton Health Sciences in Hamilton, Ontario Canada. The Hamilton-based institute is aiming to run their randomized trial in 25 hospitals in Ontario and with 1,500 COVID-19 patients. They aim to accelerate the planning process and get up and running in a month. Most trials take about a year to implement.
Remdesivir is an antiviral treatment originally developed to treat the Ebola virus. It is so promising that the FDA in the US granted it orphan drug status to expedite its development, but its producer declined the status.
Lab tests have demonstrated that the drug can slow the coronavirus? takeover of cells. Clinical trials for remdesivir started in early February in China, and there are several tests being planned, including by the WHO.
Sarilumab and tocilizumab
Two arthritis medications are thought to provide benefits to COVID-19 patients and are being tested separately. Both sarilumab and tocilizumab are rheumatoid arthritis treatments that block the IL-6 cytokine. The drugs work by suppressing the immune response of COVID-19 patients who show signs of an over-active immune system.
Results from a small Chinese study of tocilizumab show promise: 75% of patients reduced oxygen requirements within days.
Blood transfusions from COVID-19 survivors
On March 24, the FDA approved the use of plasma transfusions donated by recovered coronavirus patients to treat critically ill coronavirus patients. This treatment is centuries-old and has been shown to be effective with other viruses due to antibodies in the blood of immune individuals.
New York State, one of the most-impacted states in the US, announced it will begin trials of this therapy immediately.
Starting a COVID-19 treatment trial? We can help.
If you are starting a trial that needs to get up and running very quickly it needs thorough planning. Any mistakes in these trials could mean delays that will cost lives. Clinical trial supplies and pharmaceuticals may be in short supply during this pandemic, and you need to know how to get your hands on them.
One way to reduce the chance of mistakes or shortages is to hire logistics experts who specialize in clinical trials. These experts can help with planning, as well as packaging, storage and distribution of materials.
Here at Bay Area Research Logistics, we?re happy to help with your clinical trial. Please contact us with any questions.