Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04252664
Status:
SUSPENDED
Last Update Posted:
2020-04-15
First Post:
2020-01-31
Brief Title:
A Trial of Remdesivir in Adults With Mild and Moderate 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 Mild and Moderate COVID-19
Status:
SUSPENDED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The epidemic of COVID-19 has been controlled well at present no eligible patients can be recruitted
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 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 mild or moderate COVID-19
Given no specific antiviral therapy for COVID-19 and the 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 mild or moderate 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 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 appears to be wide encompassing asymptomatic infection a mild upper respiratory tract illness and severe viral pneumonia with respiratory failure and even death Although the per infection risk of severe disease remains to be determined and may differ from the initial reports of 10-15 the large number of cases in Wuhan has resulted in a large number of patients hospitalised with pneumonia Progression from prodromal symptoms usually fever fatigue cough to severe pneumonia requiring supplementary oxygen support mechanical ventilation or in some cases ECMO appears to occur most commonly during the second week of illness in association with persistent viral RNA detection This provides a window of opportunity to test candidate antiviral therapeutics
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 reduce risk of disease progression speed recovery and reduce the requirements for intensive supportive care and prolonged hospitalisation In addition treatments for mild cases to reduce the duration of illness and infectivity may also be of value were COVID-19 to become pandemic andor endemic in human populations
Given no specific antiviral therapy for COVID-19 and the 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 mild or moderate 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 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 appears to be wide encompassing asymptomatic infection a mild upper respiratory tract illness and severe viral pneumonia with respiratory failure and even death Although the per infection risk of severe disease remains to be determined and may differ from the initial reports of 10-15 the large number of cases in Wuhan has resulted in a large number of patients hospitalised with pneumonia Progression from prodromal symptoms usually fever fatigue cough to severe pneumonia requiring supplementary oxygen support mechanical ventilation or in some cases ECMO appears to occur most commonly during the second week of illness in association with persistent viral RNA detection This provides a window of opportunity to test candidate antiviral therapeutics
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 reduce risk of disease progression speed recovery and reduce the requirements for intensive supportive care and prolonged hospitalisation In addition treatments for mild cases to reduce the duration of illness and infectivity may also be of value were COVID-19 to become pandemic andor endemic in human populations
Given no specific antiviral therapy for COVID-19 and the 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 mild or moderate 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