Here’s How Long Clinical Trials for Possible Coronavirus Cure Will Take, According to Experts

By Published on March 20, 2020

Clinical trials to test a malaria drug for use on coronavirus patients could take anywhere from a few weeks to a few months to complete, infectious disease experts said Thursday.

Scientists who study infectious diseases are cautiously optimistic about using chloroquine or its derivative, hydroxychloroquine, to treat or even cure coronavirus patients after lab studies and a clinical trial in France showed that the malaria medication was effective against the virus.

The Food and Drug Administration said Thursday that the agency “has been working closely with other government agencies and academic centers” to investigate using chloroquine, an anti-inflammatory drug developed in the 1940s.

Several clinical trials for chloroquine are being conducted across the globe, including a 1,500-patient study that the University of Minnesota commenced.

“I’m excited about that because clinical trials are already beginning,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said Thursday on MSNBC about the prospects of using chloroquine or hydroxychloroquine to fight coronavirus.

Schaffner said clinical trials could “take a few months,” but if the drugs prove effective they can be distributed “very, very rapidly.”

He added: “Anecdotes are provocative but we really need solid data.”

Dr. Peter Hotez, the dean for the National School of Tropical Medicine at the Baylor School of Medicine, said in an interview on CNN that clinical trials could take “maybe a few weeks” or “a couple of months.”

Hotez told the Daily Caller News Foundation on Wednesday that he was “enthusiastic” about early research on using the two drugs, but that more information is needed.

“It has a lot of potential, though we’re not going on a lot of data yet,” he said.

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Government health agencies and medical researchers around the world are scrambling to develop new drugs or re-tool existing medicines to stave off coronavirus until a vaccine can be developed. Experts in the field say that a vaccine is unlikely to be developed for at least 12 months, with some estimates that it could take up to two years.

Hotez said on CNN that the using pre-existing drugs is the most readily available option, though it is not guaranteed to work. Hotez has also advocated using antibodies taken from serum of recovered coronavirus patients either to treat people at high risk of adverse outcomes from coronavirus.

At a press conference Thursday, President Donald Trump announced that he authorized the FDA to relax regulations that will speed up clinical trials for several anti-viral remedies to treat coronavirus. He also said that the drugs would be made available “almost immediately.”

Stephen Hahn, the commissioner of the FDA, tempered Trump’s remarks, telling reporters at the same press conference that scientists still have to conduct clinical trials to see if chloroquine, hydroxychloroquine, and several other anti-viral medications are actually effective against coronavirus.

Since chloroquine and hydroxychloroquine are already approved to treat malaria and arthritis, they could be used to treat other conditions, including coronavirus, on an “off label” basis.

 

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