UNMC Begins First U.S. Clinical Trial to Treat COVID-19
The first clinical trial in the U.S. of a possible coronavirus treatment is underway at UNMC and is expected to include 400 patients at 50 locations around the world, officials said last Tuesday.
Half of the patients in the international study will receive the antiviral medicine remdesivir while the other half will receive a placebo. Several other studies, including one looking at the same drug, are already underway internationally.
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institute of Health that’s the regulatory sponsor of the trial.
Dr. Andre Kalil, who will oversee the study at the University of Nebraska Medical Center, said the clinical trial was developed quickly in response to the virus outbreak that originated in China.
Patients who are hospitalized with the COVID-19, the disease caused by the virus, will be eligible to join the trial if they have at least moderate symptoms.
“The goal here is to help the people that need it the most,” Kalil said.
Fifteen people who were evacuated from a cruise ship in Japan are being treated at the University of Nebraska Medical Center. Thirteen of them have tested positive for COVID-19.
There are no proven treatments or vaccines for the new and mysterious virus, which has infected more than 80,000 people worldwide and killed more than 2,700, with the overwhelming majority of cases in China.
Doctors give patients fluids and pain relievers to try to ease the symptoms, which can include fever, cough and shortness of breath. In the case of those who are severely ill, doctors use ventilators to help them breathe or a machine that pumps and oxygenates their blood outside the body, easing the burden on the heart and lungs.
At least two patient studies are already underway in China, including the other study involving remdesivir – made by Gilead Sciences – and another that tests a combination HIV drug containing lopinavir and ritonavir.
In a draft research plan last month, the World Health Organization said remdesivir was considered “the most promising candidate.” It was used briefly in some Ebola patients in Congo before that study stopped. But the WHO cited laboratory studies that suggested it might be able to target SARS and MERS, which are cousins of the new virus.
Gilead has provided the drug for use in a small number of patients, including a man in Washington state who fell ill after a trip to Wuhan, the Chinese city at the center of the outbreak. The man is no longer hospitalized, but it is not known whether the remdesivir helped him.
Another COVID-19 Patient Transported to UNMC, brings number to 15
For the second time this week, a person who has tested positive for COVID-19 after being evacuated from a cruise ship in Japan was transferred to an Omaha hospital, officials said.
The person had been monitored at Travis Air Force Base in California but was being flown to Omaha last Tuesday night, the University of Nebraska Medical Center said in a news release. The person is the spouse of one of 13 people already being monitored and treated at the hospital.
The addition will bring the number of people being monitored at UNMC to 15. Thirteen people are being monitored at the National Quarantine Unit, while two are receiving care at the Nebraska Biocontainment Unit.
Two people continue to test negative for the virus and could leave quarantine this Monday.
– The Associated Pres
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