The Food and Drug Administration (FDA) gave emergency approval late last month for the use of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.
The FDA made this approval based on limited data to ensure the drug would be available. The FDA also encouraged that clinical trials be conducted in order to determine whether or not chloroquine and hydroxychloroquine are effective in treating the new virus.
There have been several small studies looking at how effective these drugs are at treating COVID-19. Now, the post-exposure prophylaxis (PEP) study is enrolling 2,000 participants to investigate whether or not hydroxychloroquine can disrupt the transmission of COVID-19.
Hydroxychloroquine, a less toxic metabolite of chloroquine, is a drug that was formerly only approved by the FDA for the preventative treatment of malaria, lupus erythematosus, and rheumatoid arthritis. It can have negative side effects, but the COVID-19 PEP study, led by researchers at the UW and New York University, is using a safe and well-tolerated dose.
“There are some reasons you would not start the medication for drug interactions, but by [and] large it's very safe and also importantly you can use it among people who are older,” Dr. Ruanne Barnabas, the principal investigator for the PEP study and an associate professor of global health at the UW, said.
The dose was determined using modeling to understand the benefits of differently sized doses. The goal is to get enough of the drug in the right place at the right time so that it can prevent the novel coronavirus from entering the cell.
Hydroxychloroquine has been able to hinder the ability of the virus to enter cells in laboratory tests. If the virus cannot enter the cell, then it is unable to replicate and thus unable to cause infection.
As the study will not be looking at whether or not hydroxychloroquine can disrupt the transmission of the virus that causes COVID-19, it will focus on people who have come into close contact with people who have a positive diagnosis.
Barnabas says upward of three-fourths of COVID-19 transmissions occur in close contact.
“We think with the social distancing we are getting the number of new cases down to less than one per infectious person,” Barnabas said. “But just about less than one, not necessarily much lower than that. If we can just push that down a little bit so that every infectious person infects less than one susceptible person then we can start to see control of the epidemic in the community.”
Barnabas hopes to complete the study in about eight weeks. Time is of the essence, but it is important that the study still be well done.
“The data [is] encouraging that it works in the lab,” Barnabas said. “We need rigorous science in order to answer this question so we are going to test hydroxychloroquine in a rigorous way and use the right science. We are going to figure out whether it is right for prevention.”
Reach contributing writer Teresa Bonilla at firstname.lastname@example.org. Twitter: @toomuchteresa
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