By now, most people have heard of hydroxychloroquine.  This is not a new drug and it has been used to treat malaria since the 1950s.  It also has beneficial effects for lupus erythematosus and rheumatoid arthritis.  There has been anecdotal evidence reported in the news that the drug can help treat people with COVID-19 due to the coronavirus.  There is also a lot of skepticism that it will work.  Nevertheless, some physicians in the U.S. had been using the drug off label to treat patients with COVID-19 even though it was not approved by the Food and Drug Administration (FDA) for this indication.  Physicians using a drug off label is not uncommon, especially with diseases like cancer.

On March 28, the FDA issued an Emergency Use Authorization to allow hydroxychloroquine sulfate and a similar drug, chloroquine phosphate, to be donated to the Strategic National Stockpile.  From there, the drugs will be distributed to the states and used by physicians, where appropriate, and when a clinical trial is not available.  The drug will also be used in a clinical trial underway in New York.

Novartis, a global innovator pharmaceutical company, and its division Sandoz, a global generic and biosimilar manufacturer, have offered to donate 130 million doses of the generic drug hydroxychloroquine by the end of May to support the fight against the global coronavirus pandemic. Some of this donation, 20,000 doses, will be used to support a University of Washington International Clinical Research Center clinical trial that will enroll approximately 2,000 participants to study the drug as a post-exposure preventative therapy.  This clinical trial is also supported by the Bill & Melinda Gates Foundation.

Principle investigator and Associate Professor for Global Health Ruanne Barnabas stated on March 30, that, "We currently don’t know if hydroxychloroquine works, but we will learn in as short a timeframe as possible what the outcome is” and that their “goal is to stop transmission of COVID-19 in the community.”

Her colleague and co-principal investigator, Assistant Professor of Public Health Anna Bershteyn at New York University School of Medicine said, " Currently, there is no proven way to prevent COVID-19 after being exposed.  If hydroxychloroquine provides protection, then it could be an essential tool for fighting this pandemic.  If it doesn't, then people should avoid unnecessary risks from taking the drug.”

Participants for the trial have been referred by physicians and have had close contact with people with COVID-19 or have a pending diagnosis.  The participants will be randomly assigned to take hydroxychloroquine or a placebo over two weeks and will be tested for COVID-19 daily to see if the drug is working to prevent the disease.

There is in vitro (test tube/culture dish, etc.) evidence that hydroxychloroquine is effective in fighting the coronavirus, but there has not been a large enough and well-controlled clinical trial in people to see if it is effective, which is why the study in New York is so important.

Hopes are high that this drug will work and save lives.  This clinical trial is a great example of the private sector, universities, and the government working together to solve a serious problem.