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UC Irvine in Clinical Trial to Test Drug’s Potential to Treat COVID-19

Sunday, March 29, 2020

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UC Irvine announced Monday at a digital news conference that it is participating in a clinical trial to test the antiviral drug remdesivir as a potential treatment for COVID-19, the disease caused by the coronavirus that has sparked a global pandemic. There currently is no known treatment.

Dr. Alpesh Amin, chairman of the UCI Department of Medicine and executive director of the UCI Health Hospitalist Program, said he is optimistic about the potential for remdesivir in treating COVID-19.

The drug, developed by Gilead Sciences Inc., has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses, UCI said. It previously was studied as a treatment for the Ebola virus, though it didn’t work as hoped.

“It attacks the unique genetic code on what we call the RNA of the virus,” Amin said. “It attacks it and kills it — almost like a seek-and-destroy mission that the drug has.”

COVID-19 can involve mild to severe respiratory illness, with symptoms including fever, cough and shortness of breath. In older adults and people with preexisting medical conditions that may compromise their immune systems, the illness can develop into severe pneumonia.

UCI, along with UC San Diego and UC Davis, is a designated site for the first remdesivir clinical trials in California sponsored by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. UCI is currently treating one patient in the trial, which is expected to last up to three years.

Amin said the trial aims to test up to 440 patients overall in three years. However, researchers will analyze the data after 100 patients have been treated and assess how to move forward. Amin did not have a timetable for when the study will reach the 100-patient threshold.

“The way clinical trials work is that if we find out that the drug is working extremely well, and if it improves outcomes in mortality, then a trial could stop in the middle and the manufacturer could request FDA [Food and Drug Administration] approval,” Amin said. “That is a possibility.”

Amin and Dr. Lanny Hsieh, an infectious-disease specialist, are the principal participants at UCI and will oversee the randomized, placebo-controlled trial, the university said.

Remdesivir is being studied in various clinical trials worldwide. The World Health Organization announced last week that the drug would be studied as part of a large-scale, multi-country trial that will test four drugs or drug combinations.

Two other patients were screened to take part at UC Irvine but were not enrolled due to the study’s exclusion criteria denying those with certain preexisting conditions such as liver problems or kidney disease.

According to NIAID, participants in the trial must have laboratory-confirmed coronavirus infection and evidence of lung problems, including rattling sounds when breathing, with a need for supplemental oxygen, or abnormal chest X-rays or illness requiring mechanical ventilation.

People with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included in the study.

Amin wasn’t willing to delve into the side effects of the drug.

“I would not really talk about the side effects at this point and time because we are going to be trying to learn about that as we go through this trial,” Amin said.

“We know it is safe,” he added. “Again, we need to test it with coronavirus to understand the side-effects profile.”

For more information about the trial, visit ClinicalTrials.gov and search identifier NCT04280705.

UCI Health officials said they have planned since early January to prepare UCI Medical Center staff and facilities to treat patients infected with the coronavirus.

On Saturday, UCI said a non-student resident at the university’s campus family housing had tested positive for the coronavirus after returning from an international trip showing symptoms. The person was “resting comfortably in good condition,” the university said.

The Orange County Health Care Agencyhas reported 95 cases of the virus in the county through Sunday.

Source: Los Angeles Times OC

Category: COVID-19

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