The Food and Drug Administration has given Novartis the green light to conduct a random lab test of malaria drug hydroxychloroquine to contain the onslaught of the coronavirus, the pharmaceutical firm announced late Monday.
The decades-old hydroxychloroquine has been granted FDA permission for emergency use this month for its unapproved application for coronavirus disease, but so far there has been no scientific evidence as to the safety and effectiveness of the generic vaccine.
The Swiss biotech giant is looking to start recruiting 440 subjects for its Phase 3 tests scheduled in the next coming weeks at over 12 U.S. locations. Results will be disclosed as soon as they are available, Novartis said.
Novartis said it would donate up to 130 million tablets of hydroxychloroquine to support global clinical testing programs in case the drug is found to be effective against the COVID-19. It also said its generic division Sandoz has already given out 30 million tablets to the US Department of Health and Human Services as part of its donation campaign.
The study to be conducted by Novartis will be a double-blind placebo-controlled ramdomized procedure, considered as a gold standard in medicine in which one of three options will be assigned to patients: hydroxychloroquine, combination of hydroxychloroquine and azithromycin antibiotic, or the placebo.
The program will exclude patients on ventilators and who are very ill. It will include adults who are hospitalized and are in what medical authorities call moderate to severe category, like those who require respirators.
Use of the medication, also approved for treating lupus and rheumatoid arthritis, has soared since being endorsed by US President Donald Trump, with some concerned the administration's support for an unverified drug to fight the disease has affected the FDA's oversight measures.
In April 1955, the FDA initially approved hydroxychloroquine. It was one of the first possible agents to demonstrate a capacity to slow down the SARS-CoV-2, the novel coronavirus, in lab trials. These findings, while being a useful scientific guide, are still not always translated into efficacy in people who have contracted the disease.
Meanwhile, companies like Gilead Sciences and Roche are researching older drugs designed to treat certain diseases for symptoms that could be repurposed to combat the outbreak of COVID-19. Gilead has also just broadened its testing of the Ebola drug remdesivir.
Currently, there are many other studies on hydroxychloroquine, including those at University of Washington and University of Minnesota, as well as research by the National Institutes of Health in the United States.
