Recent strong warning messages from the World Health Organization (WHO) and U.S. health officials came in response to outbreaks of the coronavirus outside China, including in Iran, Japan, South Korea, and Italy, the global circumstances suggest it's likely that this virus will cause a pandemic. U.S. public health officials also said that it’s time for Americans to start preparing now for the possibility that more aggressive, disruptive measures might be needed to stop the spread of the new coronavirus in communities across the country. (1) (2)
The Global Outbreak of COVID-19
The COVID-19（previously provisionally named 2019 novel coronavirus or 2019-nCoV）outbreak, which began in Wuhan, China, has spread in Asia, the Middle East, and Europe. As of February 26, the WHO has reported global 81109 confirmed cases (871 new) of COVID-19 and 2718 deaths (52 new) in China, 2918 cases (459 new) of COVID-19 and 44 deaths (10 new) in 48 other countries (1) (3). To date, the U.S. has 60 confirmed cases of novel coronavirus, 14 confirmed cases of the virus in people who have traveled to China and an additional 40 residents were infected with the virus are among repatriated residents who were passengers of the Diamond Princess cruise ship, docked in Yakohama, Japan, according to the US Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). (2)(4)
People infected with COVID-19 will have mild symptoms (such as fever, cough and shortness of breath) , some patients may become severe illness and death. The symptoms of COVID-19 may appear in as few as 2 days or as long as 14 days after exposure per CDC. (2)
Remdesivir, the First Clinical Trial in the United States
An Investigational New Drug Application (IND) Remdesivir is developed by American drugmaker Gilead Sciences Inc.. The drug is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Remdesivir was previously tested in patients with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) (5), more importantly, one case of COVID-19 pneumonia in the USA is responding well to Remdesivir. (6)
Based on these data and coronavirus outbreak, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) began a phase 2 randomized controlled trial for the treatment of COVID-19 patients on February 21, 2020, which is the first clinical trial of Remdesivir in the United States. (7)
According to the NIAID/NIH and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D., this clinical trial is to evaluate the safety and efficacy of the novel therapeutic antiviral Remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) if an experimental treatment can benefit patients. Although "Remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes. We urgently need a safe and effective treatment for COVID-19 according to Dr. Fauci.
The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19. The secondary objectives of the study are to 1) evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed b...
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