Despite false assertions by the president to the contrary, any potential treatments to counter or prevent COVID-19 are still only at the stage of early investigations, which include one-off treatment with special individual case authorizations, and small-scale clinical examinations. Nothing so far has approached the level of scrutiny needed to actually say anything definitively about their actual ability to treat COVID-19 or the SARS-CoV-2 virus that causes it, but the first large-scale U.S. clinical study for one treatment candidate is seeking volunteers and looking to get underway.
The study will be conducted by the Henry Ford Health System, which is seeking 3,000 volunteers from healthcare and first responder working environments. Depending on response, the researchers behind the study are looking to begin as early as next week. Study lead researcher Dr. William W. O’Neil said in a press release announcing the study that the goal is to seek a more definitive scientific answer to the question of whether or not hydroxychloroquine might work as a preventative medicine to help protect medical front-line workers with greater risk exposure from contracting the coronavirus.
Hydroxychloroquine (as well as chloroquine) has been in the spotlight as a potential COVID-19 treatment due mostly to repeated name-check that President Trump has given the drug during his daily White House coronavirus task force press briefings. Trump has gone too far in suggesting that the drug, which is commonly used both as an anti-malarial and in the treatment of rheumatoid arthritis and lupus, could be an effective treatment and should be thrust into use. At one point, he claimed that he FDA had granted an emergency approval for its use as a COVID-19 treatment, but Dr. Anthony Fauci clarified that it was not approved for that use, and that clinical studies still need to be performed to evaluate how it works in addressing COVID-19.
Studies thus far around hydroxychloroquine have been small-scale, as mentioned. One, conducted by researchers in France, produced results that indicated the drug was effective in treating those already infected, particularly when paired with a specific antibiotic. Another, more recent study from China, showed that there was no difference in terms of viral duration or symptoms when comparing treatment with hydroxychloroquine with treatment using standard anti-viral drugs, already a common practice in addressing cases of the disease.
This Henry Ford study looks like it could provide better answers to some of these questions around the drug, though the specific approach of seeking to validate prophylactic (preventative) use will mean treatment-oriented applications will still have to be studied separately. The design of the study will be a true blind study, with participants split into three groups that receive “unidentified, specific pills” (possibly anti-virals or some equivalent); hydroxychloroquine; or placebo pills, respectively. They won’t know which they’ve received, and they’ll be contacted weekly by researchers running the study, then in-person both at week four and week eight to determine if they have any symptoms of COVID-19, or any side effects from the medication. They’ll get regular blood draws, and the results will be compared to see if there’s any difference between each cohort in terms of how many contracted COVID-19.
These are front-line healthcare workers, so in theory they should unfortunately be at high risk of contracting the disease. That, plus the large sample size, should provide results that provide much clearer answers about hydroxychloroquine’s potential preventative effects. Even after the study is complete, other competing large-scale trials would ideally be run to prove out or cast doubt on these results, but we’ll be in a better position than we are now to say anything scientifically valid about the drug and its use.