FDA Makes Way for Experimental Drugs to Fight COVID-19

On March 19, the U.S. Food and Drug Administration (FDA) approved the testing of two drugs, chloroquine (hydroxychloroquine) and remdesivir, to treat people with COVID-19. The drugs have been given expanded access status, which is sometimes called “compassionate use”.¹ It is important to note that these drugs are still considered experimental for the treatment of COVID-19.

What drugs are being tested for COVID-19?

Chloroquine and hydroxychloroquine are also used to treat malaria, lupus, and rheumatoid arthritis. Both have been used for decades and are generally inexpensive and safe to use as prescribed.

Remdesivir is an experimental antiviral drug that has not yet been approved for use in the U.S. or any other country. However, it has been tested in animals to fight MERS and SARS, two other serious infections in the coronavirus family. It is in the very early stages of being tested in humans to fight the Ebola virus.

How will these drugs help treat COVID-19?

Doctors believe that chloroquine may be able to shorten how long someone is sick with COVID-19. It may also reduce how much virus the person sheds when breathing, sneezing, or coughing, which could help reduce the spread of the virus.

As of mid-March, remdesivir is being tested in about 250 adults. The first volunteer to receive remdesivir had been quarantined on the Diamond Princess cruise ship docked in Japan. The hope is to collect information about how well the drug works, how safe it is, how big or small a dose is needed, and in which type of patient it works best.¹

Doctors in China were the first to try a variety of antiviral drugs to fight COVID-19, including chloroquine and remdesivir.²

Other drugs that the FDA has given experimental status to fight COVID-19 include:

• Sarilumab (Kevzara®), to reduce lung inflammation.
• Convalescent plasma and hyperimmune globulin, to reduce the time someone is sick. These are products taken from the blood of someone who was infected with COVID-19 and now has no symptoms. The blood is concentrated and purified for medical use.
• An experimental vaccine that may prevent COVID-19 infection.

Future treatment research for COVID-19

There are no treatments currently approved by the FDA to fight COVID-19. However, doctors in several countries are experimenting with currently available drugs. The hope is to find some combination of medicines that can fight the virus.

At this time, doctors can get chloroquine and remdesivir for their COVID-19 patients through the FDA compassionate use application program.

Editorial Note: On April 24, 2020, the FDA announced that there have been reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine. Because of these reports, the FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital or a clinical trial.³ Close monitoring by a medical team is strongly recommended. Hydroxychloroquine and chloroquine can cause abnormal heart rhythms and other complications. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and have an irregular heartbeat, dizziness, or fainting, call 911 right away.

Editorial Note: On June 15, 2020, the FDA revoked the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate to treat hospitalized COVID-19 patients. The FDA found chloroquine and hydroxychloroquine ineffective in treating COVID-19, and that the serious side effects outweighed any potential benefits. Both drugs are still being studied in clinical trials. This announcement is meant to discourage doctors from prescribing these drugs off-label.⁴