Everybody is hoping for a miracle drug to treat COVID-19, the disease caused by the infectious novel coronavirus.
Now, researchers at UC Irvine have a shot at helping to find it.
As part of a national clinical trial, the Orange County team of medical scientists are authorized to use the anti-viral drug remdesivir — once developed to treat the Ebola virus — on certain COVID-19 patients hospitalized at UCI Medical Center in Orange. The study’s goal, over an unspecified period of time, will be to determine the drug’s effectiveness against a disease that has already killed more than 11,000 people.
The research is being led by Dr. Alpesh N. Amin, chair of UCI School of Medicine’s Department of Medicine and executive director of the UCI Health Hospitalist Program and fellow principal investigator Dr. Lanny Hsieh, an infectious disease specialist.
“The exciting thing is that UCI is on the cutting edge of making this available to our patients,” Amin said. “We want to be there. We want to make sure we have the right therapeutic options.”
As of Friday, March 20, when Amin spoke to The Orange County Register about the study, UCI Medical Center had two COVID-19 patients. In both cases, eligibility for the trial was being determined.
There is no known treatment at this point for COVID-19. Scientists around the world are racing to find something that can arrest the mild to severe respiratory symptoms and illness that can lead to pneumonia and, in the case of older adults and people with compromised immune systems, higher rates of death.
Remdesivir, developed by Gilead Sciences Inc., is among the potential drug therapies highlighted in recent news briefings by the White House Coronavirus Task Force. The antiviral drug, administered intravenously, also is being studied in COVID-19 clinical trials in China, where the novel coronavirus emerged late last year.
It has been shown to be safe for use in humans and has had success as a coronavirus treatment.
In January, it was administered under “compassionate use” to a Washington state man who had developed pneumonia related to COVID-19; he recovered. In late February, doctors at UC Davis Medical Center treated a critically ill COVID-19 patient with remdesivir, also under compassionate use. In a March 13 interview with Science Magazine, those doctors said the unidentified patient was “doing well.”
And last week, a 79-year-old patient in Italy, where the COVID-19 death toll has exceeded that of China, was declared cured by the drug.
Gilead, headquartered in San Mateo County, developed remdesivir as a potential treatment for the West African Ebola virus, but a 2018 clinical trial found two other drugs to be more effective. Gilead’s own tests have shown the drug’s promise in treating two other coronavirus infections, Middle East respiratory syndrome, or MERS, and severe acute respiratory syndrome, or SARS.
UCI Health — the combined clinical, medical and research arms of UC Irvine — last week joined counterparts at UC Davis and UC San Diego in research sponsored by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. The federal agency first began enrolling coronavirus patients for the study in February, at the University of Nebraska Medical Center in Omaha.
The trial is open only to hospitalized patients with what the NIH refers to as “laboratory-confirmed SARS-CoV-2 infection” showing evidence of “lung involvement that includes rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation.”
Patients who are asymptomatic, or who have only mild cold-like symptoms, are excluded from the trial.
Amin said the investigators will assess the trial’s progress after the first 100 patients have enrolled across the 20 open sites.
Participants will randomly be assigned to receive the drug, or a placebo, in the double-blind study — meaning neither patient nor investigator will know which the participant is getting. Trial protocol calls for administering 200 mg of remdesivir on Day 1, followed by a daily maintenance dose of 100 mg for the duration of hospitalization, up to a total course of 10 days.
UCI’s Dr. Amin said he did not know how many patients the trial may ultimately involve. Here are his answers to other questions.
Q: When does the trial start at UCI?
A: It’s starting now. Currently, we’re assessing the patients in house that would potentially be part of this trial.
Q: Are patients giving consent themselves or is it through a family member?
A: We have an informed consent. It will either be the patient or family member, depending on the condition of the patient.
Q: How long will the trial last and how many patients will be involved?
A: I don’t know as of right now. As we enroll patients and we start seeing the outcomes that occur, that’s going to give some directionality to the trial. Part of it also depends on how quickly we can enroll enough patients into the trial.
We don’t have a good sense yet of how many patients are going to be coming into the hospital and how many of those patients can actually meet the inclusion criteria of the trial.
It’s a little bit of a different thing than maybe other trials where you kind of have a good sense of the disease burden. We’re trying to understand the level of disease burden because it’s so new. We’re also on the cutting edge of trying to get the right therapy for managing that disease.
So it’s going to be a little bit of fluid decision making in terms of the length for the trial and how many patients we actually enroll across the country. If you ask me in a month or two, I might have a little bit better answer.
Q: Is this one of several trials going on in the U.S. or is it all one big trial in different states?
A: There are other trials that are either in motion or already have started. This one is specific about using remdesivir for the treatment of acutely ill hospitalized patients, compared to a placebo.
We’re still trying to learn what potential therapies will actually work against COVID-19. We’re talking about other potential therapy adoptions, so those will have their own trials. It’s a dynamic situation right now.
Q: How is efficacy determined; how will you know the drug is working?
A: Efficacy is determined by improvement of clinical symptoms and how quickly the clinical symptoms improve. Then ultimately, the efficacy is looking at the mortality. Is there a survivability difference between patients that take the drug versus patients that don’t?
Q: To what extent has this particular drug been used on COVID-19 patients?
A: It’s been tried experimentally. I don’t know how many countries off the top of my head. While remdesivir has shown some promise, we need some clinical data to indicate some improvements for infected patients.
Q: If this drug shows success, how soon could it be used as a therapy? What are the next steps?
A: If the study shows that (successful treatment) can be done, then it would go for FDA application. The FDA would review the data and based on the data, the FDA could give approval to the manufacturing company.
It’s basically breaking down some processes and barriers that would have taken longer in other situations. Given the situation that we are in collectively, I think the FDA would move very fast.
