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

• ClinicalTrials.gov Identifier: NCT04382586
• Recruitment Status: Active, not recruiting
• First Posted: May 11, 2020
• Last Update Posted: February 12, 2021
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: May 7, 2020
• First Posted Date: May 11, 2020
• Last Update Posted Date: February 12, 2021
• Actual Study Start Date: July 6, 2020
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• COVID-19 Pulmonary Complications
• COVID-19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 11, 2021): 93
• Original Estimated Enrollment (submitted: May 7, 2020): 52
• Estimated Study Completion Date: April 30, 2021
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04382586
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes

• Responsible Party: BeiGene
• Study Sponsor: BeiGene
• Collaborators: Not Provided

Investigators

• Study Director: Todd Zimmerman, MD; BeiGene

• PRS Account: BeiGene
• Verification Date: February 2021