NIH clinical trial of remdesivir to treat COVID-19 begins
The University of Nebraska Medical Center (UNMC) in Omaha is the receiving facility for Americans repatriated with suspicion of infection with COVID-19 (COronaVIrus Disease 2019). UNMC will be enrolling patients in a double-blind study comparing standard treatment with an investigational antiviral drug against standard treatment with a placebo. The start of this study does not mean that anyone knows, or even has has good reason to believe, that remdesivir is an effective treatment in humans for COVID-19. Remdesivir is an investigational antiviral that has been tested on other coronaviruses, but has not been shown to be effective in treating humans. Remdesivir was also studied as a possible treatment for ebola virus (a filovirus), and was found to be effective in other species, but was not found to be effective in humans.
About Remdesivir Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.What is the most common symptom? There does not appear to be any symptom that is always present. Travel to China, or to the region of China where COVID-19 was first identified, or contact with people who were in contact with people known to be infected with COVID-19 are often present, but not always. Cough and fever appear to be the most common symptoms, but that are also not always present. The full text of the first case in the US is worth reading. A 35 year old male with a cough and no fever (37.2°C – 99.0°F), but he felt like he had a fever, went to an urgent care clinic, based on his symptoms and news reports. He did not test positive for anything else that is screened for. A sample was sent to the CDC (Centers for Disease Control and Prevention). He was treated with a variety of medications. A day after he was treated with remdesivir, he began to improve. Was he just getting better on his own? We do not know, but the research at UNMC should help to answer that question. Given the number of patients, and the already known distribution of patients, there should be plenty of participants, unless someone decides to promote the political witchcraft of “compassionate use”. Then we may never know and remdesivir could become the blood-letting of the 21st century. Footnotes:  NIH clinical trial of remdesivir to treat COVID-19 begins Study enrolling hospitalized adults with COVID-19 in Nebraska. Tuesday, February 25, 2020 National Institutes of Health (NIH) News release and – NIH Clinical Trial of Remdesivir to Treat COVID-19 Begins Study Enrolling Hospitalized Adults with COVID-19 in Nebraska February 25, 2020 National Institute of Allergy and Infectious Diseases (NIAID) News release  COVID-19 Gilead Sciences Update On The Company’s Ongoing Response To COVID-19 Gilead Sciences Article  First Case of 2019 Novel Coronavirus in the United States. Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. N Engl J Med. 2020 Jan 31. doi: 10.1056/NEJMoa2001191. [Epub ahead of print] PMID: 32004427 Free Full Text from N Engl J Med.  “Right to try” laws create tremendous legal uncertainties; FDA expanded access preferable The Goldwater Institute and the Kochs pushed “right to try” laws in an attempt to get rid of FDA oversight of access to investigational drugs. Instead, they created tremendous legal uncertainties, making the FDA’s expanded access program preferable for all. Jann Bellamy January 17, 2019 Science-Based Medicine Article .
This is an experimental medicine that has only been used in a small number of patients with COVID-19 to date, so Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time.