No cure yet
4/16/2020, 6 p.m.
Re “U.Va. enrolls first patient in COVID-19 medication study,” Free Press April 9-11 edition:
It is important to educate our public on drug development. With coronavirus so prevalent in our communities, individuals are quickly jumping on the bandwagon of what they believe are miracle treatment drugs without knowing much background. The importance of clinical trials and studies are essential to the success of any new medication.
In January, Gilead, the maker of remdesivir, revealed pre-clinical data that suggested the drug could be effective against the COVID-19 virus. Pre-clinical trials are the research and development stage of a drug, where safety, toxicity, pharmacokinetics, metabolism, formation, and dosage are determined.
By February, Gilead began multiple clinical trials.
Clinical trials, which could take on average seven years, are broken down into four different phases. Phase 0 and Phase 1 are used on small sample sizes and are focused on safety. Phase 2 evaluates a slightly larger group and not only focuses on safety but also effectiveness. Phase 3 evaluates an even larger population than the prior phase.
On average, only one-third of drugs make it through Phase 3 of the clinical trial. Gilead is currently in two Phase 3 trials.
Currently, remdesivir is an investigational drug. It has been studied in Ebola and other coronaviruses known as SARS and MERS, but has not achieved adequate study results to initiate clinical development.
Remdesivir has not been approved because neither the safety nor effectiveness of the medication has been identified.It is unknown if remdesivir is the answer to treating COVID-19 without further study results. Therefore, it is imperative that individuals participate in these studies to help health care professionals determine safety and effectiveness.
In the meantime, please continue to follow social distancing, stay-at-home orders and proper handwashing techniques to decrease further spread of COVID-19. We cannot say we have found the cure quite yet.
CARISSA RUSSO
Chester
The writer is a master’s of public health candidate at the Milken Institute School of Public Health at George Washington University.