Last night, President Donald J. Trump’s personal physician issued a statement on President Trump’s health, updating his condition since he was admitted to Walter Reed Medical Center early Friday night. The statement said the president was fine and received a dose of an investigational drug, remdesivir.
“Tonight I am pleased to announce that the President is doing very well. He does not need additional oxygen, but in consultation with specialists we have decided to start the remdisevir therapy. He has completed his first dose and is resting comfortable. “
What is remdesivir and how could it help the president and others who have COVID-19?
A drug that is looking for a use
Remdesivir (brand name Veklury) has always been an investigational antiviral drug. It has never been used to treat any disease, but has been studied as a potential treatment for various diseases. At one point it was thought to be a possible treatment for both hepatitis and Ebola. The researchers also looked at whether remdesivir could treat SARS alongside other respiratory viruses.
Antiviral drugs generally work in two ways. They can kill the virus or damage the virus so that it cannot replicate and spread. This is what Remdesivir does. It prevents the virus from producing an enzyme that it needs to reproduce.
In late August, the Food and Drug Administration granted emergency approval for the drug to treat COVID-19 in adults and children, regardless of how severe the infection is. It had previously been given EUA for use in adults and children with serious illness.
COVID-19 remdesivir studies
The National Institute for Allergies and Infectious Diseases conducted a randomized, double-blind, placebo-controlled clinical study with remdesivir among 1,062 patients. Half of the patients received remdesivir and half received placebo. This type of study does not allow treating physicians, staff or patients to know which medication the patients have in order to reduce the risk of bias.
The goal was to see how long it took for patients to recover within 29 days of treatment. Patients who received the drug 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 illness were also much better 15 days later.
Another, much smaller, study had similar results.
Remdesivir treatment for COVID-19 is intravenous (IV). Although the dosage and timing may vary depending on the individual needs of the patient, it is generally administered for 10 days to patients with severe illness who require a ventilator or other forms of life support. Patients with less severe illness can receive the drug for 5 days, with an option for an additional 5 days if their doctors feel they need it.
Like all drugs, Remdesivir can cause side effects, some of which are very serious. They include:
- Dizziness on standing up
- shortness of breath
- Unusually fast or slow heartbeat
- Swelling of the face, throat, tongue, lips, or eyes.
- Pain, bleeding, pain at the IV insertion site
- Jaundice (yellowing of the whites of the eyes and skin)
- Dark urine
- Right upper abdominal pain
The emergency authorization can be revoked
According to the FDA, EUAs can be granted when an unapproved drug or product shows promise in the treatment or management of a serious or life-threatening disease or condition for which no other available treatments are available. However, EUA is not granted indefinitely and can be revoked if the FDA deems it necessary.
In June 2020, the FDA revoked the EEA it had granted for chloroquine phosphate and hydroxychloroquine, many of which it hoped would treat COVID-19:
“Based on ongoing analysis of the EEA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the EEA approved uses. In addition, given persistent 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 of its approved use. “
It remains to be seen whether remdesivir will remain available under the EEA, whether it will be approved for use or revoked.