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Trial record 1 of 1 for:    NCT04409262
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A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia (REMDACTA)

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ClinicalTrials.gov Identifier: NCT04409262
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE June 16, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Day 28 [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours [ Time Frame: Up to Day 28 ]
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to Day 28 ]
  • Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Days 7, 14, and 21 [ Time Frame: Days 7, 14, and 21 ]
  • Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline [ Time Frame: Up to Day 28 ]
  • Ventilator-Free Days from Randomization to Day 28 [ Time Frame: Up to Day 28 ]
  • Proportion of Participants Requiring Initiation of Intensive Care Unit (ICU) Care Post-baseline [ Time Frame: Up to Day 28 ]
  • Duration of ICU Stay in Days [ Time Frame: Up to Day 28 ]
  • Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) [ Time Frame: Up to Day 28 ]
    For participants entering the study already in ICU or on mechanical ventilation, clinical failure is defined as a one-category worsening on the ordinal scale, withdrawal or death.
  • Mortality Rate on Days 7, 14, 21, 28, and 60 [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  • Time to Recovery, Defined as Time from Randomization to the Time when a Category of 2, Non-ICU Hospital Ward (or "Ready for Hospital Ward") not Requiring Supplemental Oxygen, or Better is Observed [ Time Frame: Up to Day 28 ]
  • Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or </= 2L Supplemental Oxygen) [ Time Frame: Up to Day 28 ]
  • Duration of Supplemental Oxygen Use [ Time Frame: Up to Day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2020)
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Day 28 ]
  • Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to Day 28 ]
  • Plasma Concentration of Remdesivir [ Time Frame: Up to Day 28 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
Brief Summary This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • Drug: Remdesivir
    Participants will receive intravenous (IV) RDV
  • Drug: Tocilizumab
    Participants will receive IV TCZ
  • Drug: Placebo
    Participants will receive IV placebo matched to TCZ
Study Arms  ICMJE
  • Experimental: Remdesivir + Tocilizumab (RDV+TCZ)
    Participants assigned to the RDV+TCZ arm will receive an RDV loading dose followed by one infusion of TCZ on Day 1, and a once-daily maintenance dose of remdesivir from Days 2-10.
    Interventions:
    • Drug: Remdesivir
    • Drug: Tocilizumab
  • Active Comparator: Remdesivir + Placebo (RDV+Placebo)
    Participants assigned to the RDV + placebo arm will receive an RDV loading dose followed by one infusion of TCZ-placebo on Day 1, and a once-daily maintenance dose of RDV from Days 2-10.
    Interventions:
    • Drug: Remdesivir
    • Drug: Placebo
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
  • Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93%
  • Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study

Exclusion Criteria

  • Known severe allergic reactions to tocilizumab or other monoclonal antibodies
  • Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
  • Active tuberculosis (TB) infection
  • Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
  • Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing
  • Participating in other drug clinical trials
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
  • Absolute neutrophil count (ANC) < 1000/uL at screening
  • Platelet count < 50,000/uL at screening
  • Body weight < 40 kg
  • Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID #: WA42511 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Brazil,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409262
Other Study ID Numbers  ICMJE WA42511
2020-002275-34 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2020

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