COVID-19 Clinical Trial
Official title:
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Severe COVID-19.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a
potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections,
this randomized, controlled, double blind trial will evaluate the efficacy and safety of
remdesivir in patients hospitalized with severe COVID-19.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Whilst the outbreak is likely to have started from a zoonotic transmission event associated
with a large seafood market that also traded in live wild animals, it soon became clear that
person-to-person transmission was also occurring. The number of cases of infection with
COVID-19 identified in Wuhan increased markedly over the later part of January 2020, with
cases identified in multiple other Provinces of China and internationally. Mathematical
models of the expansion phase of the epidemic suggested that sustained person-to-person
transmission is occurring, and the R-zero is substantially above 1, the level required for a
self-sustaining epidemic in human populations.
The clinical spectrum of COVID-19 illness appears to be wide, encompassing asymptomatic
infection, a mild upper respiratory tract infection, and severe viral pneumonia with
respiratory failure and even death. Although the per infection risk of severe disease remains
to be determined, case-fatality risk of 11-14% has been reported in several initial studies
of seriously ill patients and case-fatality has been estimated approximately at 2% overall.
Also the large number of cases in Wuhan has resulted in a large number of patients
hospitalised with pneumonia requiring supplemental oxygen and sometimes more advance
ventilator support.
This new coronavirus, and previous experiences with SARS and MERS-CoV, highlight the need for
therapeutics for human coronavirus infections that can improve clinical outcomes, speed
recovery, and reduce the requirements for intensive supportive care and prolonged
hospitalisation.
Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a
potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections,
this randomized, controlled, double blind trial will evaluate the efficacy and safety of
remdesivir in patients hospitalized with severe COVID-19.
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