Can Remdesivir be used to treat COVID-19 (coronavirus)?

Yes, remdesivir (Veklury, GS-5734) can be used to treat COVID-19, Veklury was the first FDA approved treatment for COVID-19 in the United States.

Remdesivir (Veklury) has FDA approval for treatment for COVID-19 in patients who have had a positive SARS-CoV-2 viral test:

• who are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds) and are
• hospitalized, or
• not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

What is Remdesivir?

• Remdesivir is an antiviral drug that blocks an enzyme that the virus uses to make copies of itself, so there is a decrease in the quantity of coronavirus in the body.

• Remdesivir has also been studied in treatment of the viruses that cause MERS, SARS-CoV and Ebola.

How does Remdesivir work on COVID-19?

• For the SARS-CoV-2 virus to make you sick it has to first infect your cells.
• Secondly the virus needs to make a lot of copies of itself, so it can spread around your body which causes the COVID-19 symptoms.
• For the virus to make copies of itself, it needs an enzyme called RdRp (RNA- dependent RNA polymerase) but the Remdesivir stops the RdRp from working properly, so the virus can’t make its copies.
• This stops the virus numbers from increasing and stops the infection getting worse.

What did the Veklury clinical trials show?

ACTT-1 was a randomized, double-blind, placebo-controlled trial comparing Veklury and placebo treatment for hospitalized COVID-19 patients.

Veklury significantly improved recovery time:

• By five days in the overall study population (10 days vs 15 days).
• By seven days in patients who required oxygen support at baseline (11 days vs 18 days).

The secondary endpoint in the ACTT-1 trial showed Veklury:

• Reduced disease progression in patients needing oxygen, so that less of these patients required to go on to mechanical ventilation or ECMO (extracorporeal membrane oxygenation) (13% vs 23%).

PINETREE was a Phase 3 randomized, double-blind, placebo-controlled trial. The trial evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.
Veklury significantly reduced the risk of COVID-19 related hospitalization or all-cause death by:

• 87% by Day 28 (Veklury 0.7% vs placebo 5.3%)

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Is Remdesivir an FDA approved COVID-19 medicine?

Yes, remdesivir (Veklury) is an FDA approved medicine for treatment of COVID-19 patients who:

• have had a positive SARS-CoV-2 viral test
• are 28 days of age and older, who weigh at least 3 kilograms (about 7 pounds)
• are hospitalized,
• or not hospitalized but have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.