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COVID-19 and Treatment Drugs Frequently Asked Questions

July 24, 20201

Q: What drugs has the U.S. Food and Drug Administration (FDA) approved to treat COVID-19?
A: Currently, there are no drugs or vaccines approved by the FDA to treat patients with COVID-19. However, the FDA recently granted an Emergency Use Authorization (EUA) to allow for Remdesivir to be used only by heath care providers for hospitalized patients with COVID-19 when clinical trials are not available or feasible. The authorization does not mean that this drug is FDA-approved as safe and effective for treating COVID-19, and clinical trials are still needed to determine effectiveness.

On June 15, 2020, the FDA revoked the EUA for the emergency use of oral formulations of hydroxychloroquine and chloroquine after determining that those drugs are unlikely to be effective in treating patients with COVID-19. The revocation of the EUA letter can be found here.

Q: What is hydroxychloroquine (Plaquenil)?
A: Hydroxychloroquine is a medication available by prescription only that is approved by the FDA to treat lupus and rheumatoid arthritis, as well as to treat or prevent malaria. It is not FDA-approved for the treatment of COVID-19, and it is not authorized through an EUA for the treatment of COVID-19.

Q. What is chloroquine (Aralen)?
A: Chloroquine (also known as chloroquine phosphate) is an antimalarial medicine and available by prescription only. It is prescribed for either prevention or treatment of malaria, and certain inflammatory conditions such as lupus and rheumatoid arthritis. It is not FDA-approved for the treatment of COVID-19, and it is not authorized through an EUA for the treatment of COVID-19.

Q.: What is Remdesivir?
A.: Remdesivir is an investigational antiviral medicine to treat patients in the hospital with COVID-19. Remdesivir is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using Remdesivir to treat people in the hospital with COVID-19. Remdesivir was shown in a clinical trial to shorten the recovery time in some people. There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA.

Q: Is the antiviral drug Remdesivir effective for treating COVID-19?
A: Remdesivir has not undergone the same type of review as an FDA-approved or cleared product. Remdesivir was shown in a clinical trial to shorten the recovery time in some people, but it is still being studied. The EUA for remdesivir is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used).

Q.: Where can I get more information about Remdesivir?
A.: For more information, please read the FDA's Fact Sheet for Patients and Parent/Caregivers: Emergency Use Authorization (EUA) of Remdesivir for COVID-19. The Department of Health has also published a Summary of Remdesivir Allocation.

Q: What is Dexamethasone, and is it effective in treating COVID-19?
A: Dexamethosone is a steroid drug that was found in one study to be effective in improving COVID-19 survival in some severely ill hospitalized patients. As a steroid drug, it works to reduce inflammation that can develop in severely ill COVID-19 patients. The World Health Organization advises against the use of steroids in COVID-19 patients in the early stages of the disease because at that point it can slow the progress in clearing the virus. At this time, Dexamethasone is not FDA approved to treat COVID-19 patients.

Q: Is a high dose of Vitamin C an effective treatment for COVID-19?
A: No. There is currently no scientific evidence that high doses of Vitamin C will effectively treat or prevent COVID-19.

Q: Is a high dose of Vitamin D effective in preventing or treating COVID-19?
A: While several studies have found an association between low levels of Vitamin D and COVID-19, associations are not always causative. Therefore, this is currently no scientific evidence that high doses of Vitamin D will effectively prevent or treat COVID-19.

Q: How do I get medicine to treat COVID-19?
A: Only your health care provider can determine your treatment. If you have questions about your treatment plan, contact your health care provider. Never take a prescription medicine or drug if it is not prescribed for you by your health care provider for your health condition.

Q: Can antibiotics treat COVID-19?
A: No. COVID-19 is a virus, and antibiotics do not work against viruses as they only work on bacterial infections. Some patients may develop a bacterial infection such as pneumonia. In that case, a health care professional may treat the bacterial infection with an antibiotic.

Q: Is there a vaccine for COVID-19?
A: No, there is currently no vaccine to prevent COVID-19. There are trials underway for a COVID-19 vaccine to ensure safety and effectiveness, but it may be over a year before a vaccine is available to the public.

Q: Products online claim to prevent or treat COVID-19. Where can I report websites selling fraudulent medical products?

A: There are currently no FDA-approved drugs or vaccines for COVID-19. You can report fraudulent websites here: https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet.

Q: Who should I contact with drug-related questions?
A: You can call the FDA's Division of Drug Information at (855) 543-3784 or email druginfo@fda.hhs.gov

For additional information sources:

 

1This updates the Frequently Asked Questions for COVID-19 and Treatment Drugs last issued on May 11, 2020. Changes are shown in red font.