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

Phase 2

Completed

• Conditions: COVID-19; COVID-19 Pulmonary Complications
• Interventions: Drug: Supportive Care; Drug: Zanubrutinib; Drug: Placebo

• Registration Number: NCT04382586
• Lead Sponsor: BeiGene

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 available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-11
• Study Start: 2020-07-06
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Results First Submitted: 2022-01-31
• Results First Submitted QC: 2022-02-25
• Results First Posted: 2022-03-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Supportive Care	Supportive Care	Participants received placebo plus supportive care alone
Placebo + Supportive Care	Placebo	Participants received placebo plus supportive care alone
Zanubrutinib + Supportive Care	Supportive Care	Participants received zanubrutinib plus supportive care
Zanubrutinib + Supportive Care	Zanubrutinib	Participants received zanubrutinib plus supportive care

Primary Outcome Measures

Name	Time	Method
Time to Breathing Room Air	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.
Number of Participants With Respiratory Failure-free Survival	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Mortality	Up to Day 28	Number of participants with all-cause mortality on or before Day 28
Duration of Mechanical Ventilation	Up to Day 28	Number of days on mechanical ventilation on or before Day 28
Number of Participants Discharged Alive From the ICU	Up to Day 28	Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Number of Participants Experiencing Respiratory Failure or Death	Up to Day 28	Number of participants experiencing respiratory failure or death on or before Day 28
Number of Participants With Adverse Events	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
Number of Participants Discharged Alive	Up to Day 28	Number of participants discharged alive on or before Day 28
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale	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 Hospitalization	Up to Day 28	Number of days hospitalized on or before Day 28
PaO2:FiO2 Ratio	Baseline, Day 7, Day 14, Day 21 and Day 28	Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio

Trial Locations

Locations (10)

St Jude Medical Center; 🇺🇸 Fullerton, California, United States

Medstar Heath Research Institute Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

John D Archbold Memorial Hospital; 🇺🇸 Thomasville, Georgia, United States

The Brigham and Womens Hospital, Inc; 🇺🇸 Boston, Massachusetts, United States

Therapeutics Concepts; 🇺🇸 Houston, Texas, United States

Joe Arrington Cancer Research and Treatment Center; 🇺🇸 Lubbock, Texas, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Rutgers University Hospital; 🇺🇸 Newark, New Jersey, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States