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Completed

NCT Number: NCT04382586

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

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.

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Key information

Conditions

COVID-19 Pulmonary Complications COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Jude Medical Center, Fullerton, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Hospitalization for COVID-19 infection
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
  • 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:

  • 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
  • On a Bruton's tyrosine kinase (BTK) inhibitor
  • Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
  • 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.

Treatment and study plan

Zanubrutinib

Drug

320 mg (4 x 80 mg) capsules administered orally once daily

Other names: BGB-3111, Brukinsa

Supportive care

Drug

Supportive care treatment was selected and administered as deemed appropriate by the study investigator

Placebo

Drug

Placebo to match zanubrutinib

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Number of Participants Discharged Alive

    Time frame: Up to Day 28

    Number of participants discharged alive on or before Day 28

  4. 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

  5. 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.

  6. Duration of Mechanical Ventilation

    Time frame: Up to Day 28

    Number of days on mechanical ventilation on or before Day 28

  7. Duration of Hospitalization

    Time frame: Up to Day 28

    Number of days hospitalized on or before Day 28

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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