Last night, President Donald J. Trump’s personal physician issued a statement about President Trump’s health, updating his condition since he was admitted to Walter Reed Medical Center early Friday evening. The statement said that the President is doing well and that he had received a dose of an investigational drug, remdesivir.
“This evening, I am happy to report that the President is doing very well. He is not requiring any supplemental oxygen, but in consultation with specialists we have elected to initiate Remdisevir therapy. He has completed his first dose and is resting comfortably.”
What is remdesivir and how might it help the President and others who have COVID-19?
A drug looking for a use
Remdesivir (brand name Veklury) has always been an investigational antiviral drug. It’s never been used to treat any conditions, but has been studied as a potential treatment for several diseases. At one point, it was thought to be a possible treatment for hepatitis and Ebola. Researchers also looked to see if remdesivir could treat SARS, among other respiratory viruses.
Antiviral medications generally work in one of two ways. They can kill the virus, or they can damage the virus so it can’t replicate and spread. This is what remdesivir does. It keeps the virus from producing an enzyme it needs to reproduce.
In late August, the Food and Drug Administration issued an emergency use authorization for the drug to treat COVID-19 among both adults and children, regardless of how severe the infection is. It had been previously given EUA for use among adults and children who had severe disease.
COVID-19 remdesivir studies
The National Institute of Allergy and Infectious Diseases conducted a randomized, double-blind, placebo-controlled clinical trial of remdesivir among 1,062 patients. Half the patients received remdesivir, the other half a placebo. This type of study does not allow treating physicians, staff or patients to know which drug the patients, to reduce the risk of bias.
The goal was to see how long patients took to recover within 29 days of treatment. Patients who received the medication went home an average of 5 days faster than those who were given the placebo. Patients in the remdesivir group who had mild-to-moderate disease also were much more improved 15 days later.
Another, much smaller study, had similar results.
Remdesivir treatment for COVID-19 is given intravenously (IV). Although the dosing and timing may vary according to individual patient needs, it is generally given for 10 days to patients with severe disease, needing a ventilator or other forms of life support. Patients who have less serious illness may be given the drug for 5 days, with the option of another 5 days if their physicians feel they need it.
Like all medications, remdesivir can cause side effects, some quite severe. They include:
- Dizziness upon standing up
- Shortness of breath
- Abnormally fast or slow heartbeat
- Swelling of the face, throat, tongue, lips, or eyes.
- Pain, bleeding, soreness at the IV insertion site
- Jaundice (yellowing of the whites of the eyes and skin)
- Dark urine
- Pain in the right upper abdominal area
Emergency use authorization can be revoked
According to the FDA, EUA may be granted when an unapproved drug or product shows promise in treating or managing a serious or life threatening disease or condition for which there are no other available treatments. However, EUA is not granted indefinitely and can be revoked if the FDA deems it necessary.
In June 2020, the FDA revoked the EUA it granted for chloroquine phosphate and hydroxychloroquine, which many hoped would treat COVID-19:
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
Whether remdesivir remains available under EUA, is approved for use, or is revoked remains to be seen.