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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 : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Remdesivir Drug: Tocilizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : February 12, 2021
Estimated Study Completion Date : March 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Remdesivir + Tocilizumab (RDV+TCZ)
Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
 Drug: Remdesivir
Participants will receive intravenous (IV) RDV

Drug: Tocilizumab
Participants will receive IV TCZ
Active Comparator: Remdesivir + Placebo (RDV+Placebo)
Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.
 Drug: Remdesivir
Participants will receive intravenous (IV) RDV

Drug: Placebo
Participants will receive IV placebo matched to TCZ


Outcome Measures
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Primary Outcome Measures :
  1. Time from administration of tocilizumab/placebo to hospital discharge or "ready for discharge," Defined as a Score of 1 on a 7-point Ordinal Scale [ Time Frame: Up to Day 28 ]

Secondary Outcome Measures :
  1. Time to mechanical ventilation or death, defined as the time from administration of tocilizumab/placebo to the first occurrence of mechanical ventilation or death (whichever occurs first) [ Time Frame: Up to Day 28 ]
  2. Time to improvement, defined as the time from administration of tocilizumab/placebo to an improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status [ Time Frame: Up to Day 28 ]
  3. Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Days 7, 14, 21, 28, and 60 [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  4. Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline up to Day 28 and Day 60 [ Time Frame: Up to Day 28 and Day 60 ]
  5. Proportion of participants who are alive and free of respiratory failure at (participants requiring ventilation at baseline) up to Day 28 and Day 60 [ Time Frame: Up to Day 28 and Day 60 ]
  6. Duration of Mechanical Ventilation (participants requiring mechanical ventilation at baseline) [ Time Frame: Up to Day 60 ]
  7. Time to death up to Days 28 and 60 [ Time Frame: Up to Day 28 and Day 60 ]
  8. Mortality Rate on Days 14, 28, and 60 [ Time Frame: Days 14, 28, and 60 ]
  9. Time to recovery, defined as time from administration of tocilizumab/placebo 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 ]

Other Outcome Measures:
  1. Percentage of Participants with Adverse Events (AEs) Tabulated by Severity [ Time Frame: Up to 60 days ]
  2. Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to 60 days ]
  3. Plasma Concentration of Remdesivir [ Time Frame: Days 4 and 7 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. In addition, participants with prior or current treatment with > 2 doses of remdesivir for COVID-19 are excluded
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409262


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Gilead Sciences
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04409262    
Other Study ID Numbers: WA42511
2020-002275-34 ( EudraCT Number )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
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/ourmember/roche/). 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections