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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382586
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
COVID-19 Pulmonary Complications COVID-19 Drug: Zanubrutinib Drug: Supportive Care Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Cohort 1: Zanubrutinib + Supportive Care
Participants not requiring mechanical ventilation (Cohort 1) will receive zanubrutinib plus supportive care
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.

Active Comparator: Cohort 1: Placebo + Supportive Care
Participants not requiring mechanical ventilation (Cohort 1) will receive placebo plus supportive care alone
Drug: Supportive Care
Supportive care treatment is selected and administered as deemed appropriate by the study investigator.

Drug: Placebo
Placebo to match zanubrutinib

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Median reduction in days spent on supplemental oxygen [ Time Frame: Up to 28 Days ]
  2. All-cause mortality [ Time Frame: Up to 28 Days ]
  3. Proportion of participants experiencing respiratory failure or death [ Time Frame: Up to 28 Days ]
  4. Mechanical ventilation-free survival [ Time Frame: Up to 28 Days ]
  5. Days on mechanical ventilation [ Time Frame: Up to 28 Days ]
  6. Duration of hospitalization [ Time Frame: Up to 28 Days ]
  7. Time to discharge [ Time Frame: Up to 28 Days ]
  8. PaO2:FiO2 and/or oxygenation index [ Time Frame: Up to 28 Days ]
  9. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT04382586


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Todd Zimmerman, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04382586    
Other Study ID Numbers: BGB-3111-219
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by BeiGene:
Corona Virus
COVID-19
Additional relevant MeSH terms:
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Infection
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action