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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382586
• Other study ID #: BGB-3111-219
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2022
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. 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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pulmonary Complications

Intervention

Drug:
• Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
• Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
• Placebo
Placebo to match zanubrutinib

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Brigham And Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	St. Jude Medical Center	Fullerton	California
United States	Therapeutic Concepts	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Covenant Health System	Lubbock	Texas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	Rutgers University Hospital	Newark	New Jersey
United States	Atlantic Health System, Inc. / Chilton Medical Center	Pompton Plains	New Jersey
United States	Honor Health	Scottsdale	Arizona
United States	SIU School of Medicine	Springfield	Illinois
United States	Overlook Medical Center	Summit	New Jersey
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	John D. Archbold Memorial Hospital	Thomasville	Georgia
United States	MedStar Heath Research Institute/ MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Respiratory Failure-free Survival	Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28	Up to Day 28
Primary	Time to Breathing Room Air	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.	Up to 7 months
Secondary	Number of Participants Experiencing Respiratory Failure or Death	Number of participants experiencing respiratory failure or death on or before Day 28	Up to Day 28
Secondary	Number of Participants With All-cause Mortality	Number of participants with all-cause mortality on or before Day 28	Up to Day 28
Secondary	Number of Participants Discharged Alive	Number of participants discharged alive on or before Day 28	Up to Day 28
Secondary	Number of Participants Discharged Alive From the ICU	Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28	Up to Day 28
Secondary	Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale	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.	Up to Day 28
Secondary	Duration of Mechanical Ventilation	Number of days on mechanical ventilation on or before Day 28	Up to Day 28
Secondary	Duration of Hospitalization	Number of days hospitalized on or before Day 28	Up to Day 28
Secondary	PaO2:FiO2 Ratio	Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio	Baseline, Day 7, Day 14, Day 21 and Day 28
Secondary	Number of Participants With Adverse Events	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	Up to 7 months