An antiviral drug that one Palo Alto woman has credited in her recovery from a severe case of COVID-19 in March is undergoing numerous fast-tracked clinical trials across the globe, and some researchers are hoping to see it gain approval from the U.S. Food and Drug Administration (FDA) in as little as a month.
Researchers are taking a close look at remdesivir, an experimental drug developed by Foster City-based biopharmaceutical company Gilead Sciences Inc. for use against the Ebola virus.
Scientists, including a team at Stanford Hospital, are examining whether remdesivir can prevent the coronavirus from replicating.
"The RNA virus gets into the cells and uses them as little hotels (to replicate)," said Kari Nadeau, co-investigator and professor of pediatric food allergy, immunology and asthma at the School of Medicine.
With the virus proliferating, some COVID-19 patients' immune systems overreact, causing severe symptoms that lead to death. Researchers hope that limiting the virus' replication will prevent the immune system from becoming overly active.
The study of remdesivir, one of two taking place at Stanford Hospital, began enrolling patients on March 30. Stanford is collaborating with 65 other sites worldwide; the aim is to study the drug's effects on 600 patients.
The Stanford patients will receive an intravenous dose of the medication daily for 10 days. The researchers will see how the patients do over a 15-day period. Nadeau said they expect to see a difference between the control group and those who receive the drug. They hope the drug will result in fewer people needing ventilators and fewer deaths.
Neera Ahuja, the study's principal investigator and division chief of hospital medicine at Stanford University School of Medicine, said if the evidence is convincing of the drug's effectiveness, and the side effects and adverse reactions pass federal scrutiny, the FDA approval could come within a month.
"That's unheard of in the non-pandemic world," she said.
But the ambition to see approval of the drug speaks to the urgent need to treat COVID-19, which has thus far sickened 1.3 million people and killed nearly 75,000 globally. Testing of remdesivir has in some clinical trials already reached Phase 3, the stage prior to FDA approval.
Gilead stated in an announcement that the drug has shown promising results in animals against the forms of coronavirus that cause Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
Ahuja said currently, remdesivir can only be administered intravenously in the hospital. If it is approved by the FDA, there's also hope it could eventually be available in a capsule or liquid and administered in an outpatient setting, similar to Tamiflu, an antiviral drug that is used against influenza.
Other trials of remdesivir are ongoing: Among the National Institutes of Health (NIH) trials of the drug is one involving patients who are on ventilators; another is studying patients with moderate COVID-19 symptoms. A third will compare the results for moderately ill patients who will be given the drug and for people who only receive standard care. The studies involve dozens of hospitals throughout California, including the VA Palo Alto Health Care System, Stanford Hospital and Clinics, Kaiser Permanente and the Regional Medical Center in San Jose. Gilead also is involved in studies using remdesivir in China and France.
Though researchers are focused on whether remdesivir can aid in the treatment of COVID-19 patients, much is still unknown about the coronavirus, including whether it could mutate.
Some coronaviruses, such as the ones causing the "common cold," can mutate readily.
"A cousin of the coronavirus, the rhinovirus, mutates a lot," Nadeau said.
A rapidly mutating virus can make it difficult for researchers to develop a vaccine, she said. But "so far, we are not seeing the degree of mutation in COVID-19 as in the common cold."
Researchers also want to know if a person will develop lifetime immunity if they have the virus.
On April 4, Gilead announced it has produced 1.5 million doses of remdesivir to treat about 140,000 patients, which includes its drug trials, compassionate-care supplies to hospitals for pregnant women and children, and its expanded-access program for patients who are in the most serious condition and can't be part of a clinical trial. Gilead is supplying the doses at no charge.
The company is expanding its production of the drug and could have 500,000 treatment courses by October and 1 million by the end of the year, it said.
Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.