Two recent papers summarized one in vitro research and a small scale clinical study was enough for Donald Trump to make the FDA enforce a new drug clinical indication for hydroxychloroquine: improve symptoms of Coronavirus (Covid-19)-affected patients.
This is probably the fastest track of a drug approval process in the modern history, and the president is apparently right. Surprising for a global leader that has not much affection for science.
The first evidence about hydroxychloroquine on the virus came from this paper published yesterday on Cell DiscoveryIt’s just in vitro, with all the limitations, but it clearly shows the potential of the drug to kill the virus. When they submitted the paper 80,000 cases were confirmed in China, including 2946 deaths as well as over 10,566 confirmed cases in 72 other countries. At that time, the biggest hope was deposited on a drug called remdesivir.
But the greatest news came from a small-scale clinical study published on day before. The title is Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an openlabel non-randomized clinical trial and can be downloaded on its “in press” version
In a study with only 20 patients, the authors showed that hydroxychloroquine was effective against the coronavirus Covid-19 infection. In fact, it reduced 75% of infected individuals in the 6-day period, which is awesome. Even better than that, the combination with azithromycin improved the treatment efficacy to 95%.
The treatment improved the symptoms, while also reduced the viral load in the patients. The drug has been previously approved for malaria, which means that it’s considered safe. The “sister” drug chloroquine was less effective. Good for us, because it’s algo more toxic.
The study was non-randomized and it’s small scale one, however, it seems that while the epidemy started in China, the solution comes from a global community effort. The in vitro paper is actually Chinese, while the clinical one is European, more precisely from France. Interestingly, the original drug registrations for hydroxychloroquine is from the french pharmaceutical company Sanofi, and the recent clinical study was conducted in Marseille. Ale le bleu!
Please cite this work as Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949