A Phase 3 interventional study of Remdesivir and Remdesivir placebo in COVID-19 and SARS-CoV-2, sponsored by Capital Medical University. Suspended at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment
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.
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 and/or 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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 308 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalised with:
Exclusion Criteria:
active remdesivir
Drug: Remdesivir
Placebos matched remdesivir
Drug: Remdesivir placebo
RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Also known as: GS-5734
RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Time to Clinical recoveryTime to Clinical Recovery (TTCR)
TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalisation and alleviation criteria: * Fever - \<37°C, * Respiratory rate - ≤24/minute on room air, * Oxygen saturation - \>94% on room air, * Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Time frame: up to 28 days
All cause mortality
baseline SpO2 during screening, PaO2/FiO2 \<300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Time frame: up to 28 days
Frequency of respiratory progression
Defined as SPO2≤ 94% on room air or PaO2/FiO2 \<300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Time frame: up to 28 days
Time to defervescence (in those with fever at enrolment)
Time frame: up to 28 days
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)
Time frame: up to 28 days
Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnoea at enrolment rated as severe or moderate,)
Time frame: up to 28 days
Frequency of requirement for supplemental oxygen or non-invasive ventilation
Time frame: up to 28 days
Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen
Time frame: up to 28 days
Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve.
Time frame: up to 28 days
Frequency of requirement for mechanical ventilation
Time frame: up to 28 days
Frequency of serious adverse events
Time frame: up to 28 days
Plan to share: Undecided
This study is suspended, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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