FDA Issues Emergency Authorization of Hydroxychloroquine Amid Coronavirus Pandemic


The Telangana government on Monday began administering hydroxychloroquine tablets - used to fight malaria - to hundreds of doctors and healthcare workers treating Covid-19 patients as a precautionary measure.

HHS announced Sunday it had accepted donations of 30 million doses of hydroxychloroquine sulfate and a million doses of chloroquine phosphate to treat individuals diagnosed with COVID-19 in hospitals or in clinical trials.

The emergency-use authorization is for two oral prescription drugs, hydroxychloroquine and chloroquine, which are used primarily to treat malaria, but are now being investigated by federal agencies, including the National Institutes of Health and the Biomedical Advanced Research and Development Authority, as possible treatments for the coronavirus.

The authorization will allow the drugs, chloroquine and hydroxychloroquine, to be donated to the national stockpile and to be prescribed by doctors to COVID-19 patients without a need for the drug to go through clinical trials.

A multi-site clinical trial, led by the University of Washington School of Medicine in collaboration with New York University Grossman School of Medicine, aims to definitively determine whether hydroxychloroquine can prevent transmission in people exposed to the virus. Sandoz and Bayer are the latest companies stepping up to strengthen the USA response to COVID-19, and ASPR is working with additional companies willing to donate doses of hydroxychloroquine and chloroquine.

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But several hours later, government officials said the quarantine order had been in effect for more than 12 hours already. On Sunday, Hajdu said the government was looking at all the measures in their tool box, including criminal penalties.

The trial is expected to last eight weeks, and researchers hope to have the results by summer.

For the study, researchers in NY and Washington state plan to enroll 2,000 participants who are close contacts of people with confirmed or pending COVID-19 diagnoses.

"Currently, there is no proven way to prevent COVID-19 after being exposed", says Anna Bershteyn, assistant professor of population health at NYU and co-principal investigator on the study.

HHS said it is also funding clinical trials for two other drugs, Kevzara and remdesivir. "If it doesn't, then people should avoid unnecessary risks from taking the drug". For some COVID-19 patients, it can take up to 28 days to recover, if at all they did.

Some of the medicines are used in the treatment of other diseases, such as malaria.