Safety and Efficacy – The Data We Need for a COVID-19 TreatmentBookmark this
While the world anxiously awaits an approved treatment for COVID-19 it’s important to remember why we need to conduct clinical trials to get the essential data required to know if the treatment is both safe and effective.
First let’s review the clinical trial process
The clinical trial process consists of preclinical trials and then may advance to human clinical research trials. Human trials are conducted in phases: phase 1, phase II, phase III and lastly phase IV aftermarket trials. Each phase collects and provides data that determines if the investigational drug is effective and safe to proceed to the next phase. This data and process is critical as phase II and phase III trials involve a much larger study population than phase I. Part of the safety aspect also includes implementing a data and safety monitoring board to oversee the interim results regularly to determine if the trial should continue proceeding as is, if changes need to be made or if the study should be stopped due to safety concerns or lack of efficacy.
Now let’s look at some drugs being touted in the media:
Gilead’s Remdesivir is one of the potential COVID-19 vaccine frontrunners. The New England Journal of Medicine published the limited data on 53 patients that were treated with the investigational antiviral. While the results were hopeful elevated liver ALT and AST enzymes also occurred in 23% of the patients. Reminding us how important more trials and data are before anything is approved for the masses.
While Chloroquine and Hydroxychloroquine are approved drugs to treat malaria and is prescribed off-label for some autoimmune diseases we need to know if it is safe and effective specifically for COVID-19; remember, this is a novel virus.
These drugs may also cause serious side effects such as permanent vision changes, heart rhythm changes and severe hypoglycemia. These side effects are particularly concerning as patients with comorbidities such as heart disease and diabetes are at increased risk of developing severe symptoms from COVID-19. I personally experienced the hypoglycemia side effect of Hydroxychloroquine and after researching more about the drug I discovered it was being investigated in a clinical trial for a potential Type 2 diabetes treatment. In fact, in 2015 India approved the use of Hydroxychloroquine in Type 2 diabetes due to its ability to lower blood sugar levels. Taking Hydroxychloroquine in combination with other diabetic drugs may lower blood sugar levels to dangerous and possibly detrimental levels.
Side effects can also be severe or even fatal as a quick review of the catastrophic phase 1 TGN1412 trial that was conducted in the UK in 2006 also reminds us. When TGN1412 was administered in six healthy volunteers all six experienced life threating reactions within 12 hours.
As we are eagerly awaiting an approved treatment we must not forget the need for solid data. The safety aspect is critical as we need to learn about the side effects and adverse events that may be associated with the potential treatment and various dosage levels. We also need the efficacy data to know if the investigational treatment is effective and the benefits outweigh the associated risks. We cannot know this without conducting clinical trials and obtaining the data required to move forward. In conjunction with all of you, I look forward to the day we have this and can celebrate a proven treatment!