The U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation to remdesivir to treat persons with Covid-19. Remdesivir is an antiviral agent currently in development by Gilead Sciences. The drug is not approved to treat patients with Covid-19 but it is being investigated this and possibly for other viral infections (Ebola, SARS, MERS).
FDA’s Orphan Drug Designation is an incentive program to promote the development of drugs for rare conditions. If the drug is approved, it will provide the drug developer (Gilead Sciences) with seven-year market exclusivity as well as various reductions in taxes and user fees.
Demand for the drug by the public has necessitated the company to suspend its compassionate use program for remdesivir and switch to an expanded access program. This approach will allow accelerated access to remdesivir for severely ill patients and also enable the company to properly collect data from all participating patients.
The drug is currently in a phase 3 clinical trial to determine if the drug is safe and effective. A total of 600 people are being recruiting for the trial in various locations around the world. In the United States, the following locations are recruiting patients.
- Hoag Memorial Hospital Presbyterian; Newport Beach, California
- Stanford Hospital; Stanford, California
- University of Chicago; Chicago, Illinois
- Brigham & Women’s Hospital and Harvard Medical School; Boston, Massachusetts
- The Miriam Hospital; Providence, Rhode Island
- Providence Medical Research Center; Everest, Washington
- Swedish Center for Comprehensive Care; Seattle, Washington
Only persons with the following inclusion criteria are eligible for the trial:
- Willing and able to provide written informed consent prior to performing study procedures
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
- Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
- Radiographic evidence of pulmonary infiltrates
At present, there is no treatment approved for Covid19. Earlier this week, a study published in the New England Journal of Medicine noted that the combination of lopinavir and ritonavir did not find that treatment to be any more effective than standard care.