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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 : Active, not recruiting
First Posted : May 11, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE July 6, 2020
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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)
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 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 is 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.
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 is selected and administered as deemed appropriate by the study investigator.
  • Drug: Placebo
    Placebo to match zanubrutinib
Study Arms  ICMJE
  • Experimental: Cohort 1: Zanubrutinib + Supportive Care
    Participants not requiring mechanical ventilation (Cohort 1) will receive zanubrutinib plus supportive care
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Supportive Care
  • Active Comparator: Cohort 1: Placebo + Supportive Care
    Participants not requiring mechanical ventilation (Cohort 1) will receive placebo plus supportive care alone
    Interventions:
    • Drug: Supportive Care
    • Drug: Placebo
  • Experimental: Cohort 2: Zanubrutinib+Supportive Care
    Participants who have been on mechanical ventilation for ≤ 24 hours (Cohort 2) will receive zanubrutinib plus supportive care alone for respiratory distress due to COVID-19 infection for up to 28 days
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Supportive Care
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 11, 2021)
93
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
52
Estimated Study Completion Date  ICMJE April 30, 2021
Actual Primary Completion Date February 2, 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. Cohort 1: Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 48 hours. Cohort 2: Participants will have been on mechanical ventilation for ≤ 24 hours from the time of screening
  4. Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

  1. Participant is on mechanical ventilation for > 24 hours
  2. 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
  3. On a BTK inhibitor
  4. Planned or concurrent use of tocilizumab
  5. Participants with cancer

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
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Todd Zimmerman, MD BeiGene
PRS Account BeiGene
Verification Date February 2021

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