The FDA today cleared this drug for use today. President Trump announced it at his press conference. He had the FDA cut all the red tape.
They will be using the drug and collecting information on the drug on infected patients. It will be a clinical trial in those terms but the drug itself has already been approved for human use. The drug by Gilead is in pure clinical trials and has as yet not been approved.
"The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients"
with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19."
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fda.gov/news-events/pr…
"HHS Secretary Alex Azar. “Today’s actions show that HHS and the United States are leading the world in these efforts. Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics"
FDA Commissioner Stephen Hahn, M.D. “We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments.
At the same time, we will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures. If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it.
We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”
