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Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

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: NCT04382586
Recruitment Status : Completed
First Posted : May 11, 2020
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 11, 2020
Results First Submitted Date  ICMJE January 31, 2022
Results First Posted Date  ICMJE March 2, 2022
Last Update Posted Date March 2, 2022
Actual Study Start Date  ICMJE July 6, 2020
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2022)
  • Number of Participants With Respiratory Failure-free Survival [ Time Frame: Up to Day 28 ]
    Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
  • Time to Breathing Room Air [ Time Frame: Up to 7 months ]
    Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
Respiratory failure-free survival rate at day 28 [ Time Frame: 28 Days ]
Respiratory failure-free survival rate 28 is defined as the proportion of patients who have not had respiratory failure nor died <= 28 days from randomization.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2022)
  • Number of Participants Experiencing Respiratory Failure or Death [ Time Frame: Up to Day 28 ]
    Number of participants experiencing respiratory failure or death on or before Day 28
  • Number of Participants With All-cause Mortality [ Time Frame: Up to Day 28 ]
    Number of participants with all-cause mortality on or before Day 28
  • Number of Participants Discharged Alive [ Time Frame: Up to Day 28 ]
    Number of participants discharged alive on or before Day 28
  • Number of Participants Discharged Alive From the ICU [ Time Frame: Up to Day 28 ]
    Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
  • Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale [ Time Frame: Up to Day 28 ]
    Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.
  • Duration of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
    Number of days on mechanical ventilation on or before Day 28
  • Duration of Hospitalization [ Time Frame: Up to Day 28 ]
    Number of days hospitalized on or before Day 28
  • PaO2:FiO2 Ratio [ Time Frame: Baseline, Day 7, Day 14, Day 21 and Day 28 ]
    Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
  • Number of Participants With Adverse Events [ Time Frame: Up to 7 months ]
    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), and TEAEs grade 3 or higher, including laboratory findings
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • Median reduction in days spent on supplemental oxygen [ Time Frame: Up to 28 Days ]
  • All-cause mortality [ Time Frame: Up to 28 Days ]
  • Proportion of participants experiencing respiratory failure or death [ Time Frame: Up to 28 Days ]
  • Mechanical ventilation-free survival [ Time Frame: Up to 28 Days ]
  • Days on mechanical ventilation [ Time Frame: Up to 28 Days ]
  • Duration of hospitalization [ Time Frame: Up to 28 Days ]
  • Time to discharge [ Time Frame: Up to 28 Days ]
  • PaO2:FiO2 and/or oxygenation index [ Time Frame: Up to 28 Days ]
  • Change from Baseline to Day 14 in WHO - 8 Point Ordinal Scale [ Time Frame: Up to 28 Days ]
    This scale evaluates the safety and efficacy of investigational therapeutic agents in combination with care for the treatment of hospitalized participants suffering from COVID-19 infections on a scale of scores from 0 to 8, with higher scores indicating higher level of severity of the disease. (0 = No clinical or virological evidence of disease, and 8 = Death)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Official Title  ICMJE A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
Brief Summary The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19 Pulmonary Complications
  • COVID-19
Intervention  ICMJE
  • Drug: Zanubrutinib
    320 mg (4 x 80 mg) capsules administered orally once daily
    Other Names:
    • BGB-3111
    • Brukinsa
  • Drug: Supportive Care
    Supportive care treatment was selected and administered as deemed appropriate by the study investigator
  • Drug: Placebo
    Placebo to match zanubrutinib
Study Arms  ICMJE
  • Experimental: Zanubrutinib + Supportive Care
    Participants received zanubrutinib plus supportive care
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Supportive Care
  • Active Comparator: Placebo + Supportive Care
    Participants received placebo plus supportive care alone
    Interventions:
    • Drug: Supportive Care
    • 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 Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2022)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
52
Actual Study Completion Date  ICMJE February 1, 2021
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Hospitalization for COVID-19 infection
  2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
  3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening

Key Exclusion Criteria:

  1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
  2. On a Bruton's tyrosine kinase (BTK) inhibitor
  3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
  4. Participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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 United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT04382586
Other Study ID Numbers  ICMJE BGB-3111-219
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Study Director BeiGene
PRS Account BeiGene
Verification Date February 2022

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