The US National Institute of Allergy and Infectious Diseases (NIAID) has announced the initiation of a new clinical trial to assess the safety and efficacy of the investigational antiviral remdesivir in coronavirus – also known as COVID-19.
The trial is the first of its kind to evaluate an experimental treatment for COVID-19, which has been spreading since it was first detected in December 2019 in Wuhan, Hubei Province, China.
As a result of the global health threat, there have been 80,238 cases and 2,700 deaths in 34 countries reported to the World Health Organisation (WHO).
The hopeful drug in question, remdesivir, is Gilead’s investigational broad-spectrum antiviral treatment that 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. Gilead has confirmed that the first trial participant is an American volunteer who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan.
NIAID director and US coronavirus task force member Anthony S Fauciurgently reminded that we “urgently need a safe and effective treatment for COVID-19.”
He continued to say: “Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes, a randomised, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
An independent data and safety monitoring board (DSMB) will monitor ongoing results to ensure patient well-being and safety as well as study integrity, and will also recommend the study be halted if there is clear and substantial evidence of a treatment difference between drug and placebo.
In other coronavirus efforts, earlier this week GlaxoSmithKline (GSK) announced the initiation of a partnership with China-based Clover Biopharmaceuticals, in order to help develop its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer).
The developments all come as Matt Hancock, the UK’s Health Secretary, is warning that people flying home from any areas quarantined by the Italian government should self-isolate, whether they show symptoms or not, admitting he is “pretty worried” about the situation.
