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Trial record 1 of 35 for:    remdesivir
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A Trial of Remdesivir in Adults With Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257656
Recruitment Status : Terminated (The epidemic of COVID-19 has been controlled well in China, no eligible patients can be enrolled at present.)
First Posted : February 6, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Bin Cao, China-Japan Friendship Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE February 6, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ]
The primary endpoint is time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 ꞊ discharged; 6 ꞊ death) or live discharge from hospital. Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ]
TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
  • Clinical status [ Time Frame: days 7, 14, 21, and 28 ]
    Clinical status, assessed by the ordinal scale at fixed time points (days 7, 14, 21, and 28).
  • Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours. [ Time Frame: up to 28 days ]
    Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
  • All cause mortality [ Time Frame: up to 28 days ]
  • Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
  • Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
  • Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
  • Length of hospital stay (days) [ Time Frame: up to 28 days ]
  • Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
  • Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
  • Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Remdesivir in Adults With Severe COVID-19
Official Title  ICMJE 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.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Remdesivir
  • SARS-CoV-2
Intervention  ICMJE
  • Drug: Remdesivir
    RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
    Other Name: GS-5734
  • Drug: Remdesivir placebo
    RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Study Arms  ICMJE
  • Experimental: Remdesivir group
    active remdesivir
    Intervention: Drug: Remdesivir
  • Placebo Comparator: Control group
    Placebos matched remdesivir
    Intervention: Drug: Remdesivir placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 13, 2020)
237
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2020)
452
Actual Study Completion Date  ICMJE April 10, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years at time of signing Informed Consent Form
  2. Laboratory (RT-PCR) confirmed COVID-19.
  3. Lung involvement confirmed with chest imaging
  4. Hospitalized with a SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio <300mgHg
  5. ≤12 days since illness onset
  6. Willingness of study participant to accept randomization to any assigned treatment arm.
  7. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.

Exclusion Criteria:

  1. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
  2. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
  3. Pregnant or breastfeeding, or positive pregnancy test in a predose examination
  4. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
  5. Will be transferred to another hospital which is not the study site within 72 hours.
  6. Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04257656
Other Study ID Numbers  ICMJE CAP-China remdesivir 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bin Cao, China-Japan Friendship Hospital
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Capital Medical University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP