Virus World

A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

The first trial participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study. The study can be adapted to evaluate additional investigative treatments and to enroll participants at other sites in the U.S. and worldwide. There are no specific therapeutics approved by the Food and Drug Administration (FDA) to treat people with COVID-19, the disease caused by the newly emergent SARS-CoV-2 virus (formerly known as 2019-nCoV). Infection can cause mild to severe respiratory illness, and symptoms can include fever, cough and shortness of breath. As of February 24, the World Health Organization (WHO) has reported 77,262 confirmed cases of COVID-19 and 2,595 deaths in China and 2,069 cases of COVID-19 and 23 deaths in 29 other countries. There have been 14 confirmed COVID-19 cases reported in the United States and an additional 39 cases among persons repatriated to the United States, according to the Centers for Disease Control and Prevention (CDC)

Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and 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. “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 NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Gilead Sciences Inc said on Thursday it was assessing whether its experimental Ebola treatment could be used against the new coronavirus that has sickened hundreds of people in China and led to at least 18 deaths. “Gilead is in active discussions with researchers and clinicians in the United States and China regarding the ongoing Wuhan coronavirus outbreak and the potential use of remdesivir as an investigational treatment,” a company spokesman said in an emailed statement. Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) told Reuters his agency was working with Gilead to test the company’s antiviral drug in people infected with the new coronavirus.

NIAID had previously tested remdesivir in patients with Ebola and found it to be ineffective. Fauci said there is some indication that it may work better against this new virus from China. Coronavirus infections can lead to respiratory illnesses, some of which can be severe and deadly such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). They can also be much milder. The common cold is a strain of coronavirus.