Transcript
“Recently, there has been significant debate in the media over the role of hydroxychloroquine in the treatment of COVID-19 infection. To further understand this question, I would first like to describe the process by which the medication is developed and approved. Prior to any approval of a medication, a thorough and rigorous process is required called preclinical studies or laboratory studies. Here, medications that show promising results are tested on animals to understand treatment mechanism and safety threshold. If the study is considered to be relatively safe, the FDA grants permission to begin testing on a small group of healthy volunteers. This phase determines the dose of which the new treatment can be given safely without causing severe side effects. Next, Phase Two and Phase Three clinical trials address questions such as, “”Does the treatment work, and if so, is it better than what is currently available?”” A randomized study is conducted by the physicians giving either the treatment drug or a placebo, which is similar to taking a sugar pill.
The effect of medication is then compared from these two groups to understand the treatment benefits and the side effects. Clinical trial studies aim to minimize biases, which could affect the interpretation of the results. Now, referring back to the question of COVID-19 and the role of hydroxychloroquine, the evidence from the initial smaller studies were inadequate, with multiple biases and erroneous conclusion, with received much unwanted attention. More recent report from large clinical trial concluded that the use of hydroxychloroquine is not beneficial for patients with COVID-19. It is not known to decrease the rate of infection or hospitalization or the number of hospital stay. In case of sick COVID-19 patients, it is not known to decrease the need for mechanical ventilation. It is also not known to decrease the overall risk of death due to COVID-19 infection.”