Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04257656
Status:
TERMINATED
Last Update Posted:
2020-04-15
First Post:
2020-01-31
Brief Title:
A Trial of Remdesivir in Adults With Severe COVID-19
Sponsor:
Capital Medical University
Organization:
Capital Medical University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The epidemic of COVID-19 has been controlled well in China no eligible patients can be enrolled at present
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None