Clinical trial NCT04382586: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Pulmonary Complications
COVID-19
Keywords: Corona Virus
COVID-19
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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. 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.

Primary outcomes:
measure: Number of Participants With Respiratory Failure-free Survival
timeFrame: Up to Day 28
measure: Time to Breathing Room Air
timeFrame: Up to 7 months
Secondary outcomes:
measure: Number of Participants Experiencing Respiratory Failure or Death
timeFrame: Up to Day 28
measure: Number of Participants With All-cause Mortality
timeFrame: Up to Day 28
measure: Number of Participants Discharged Alive
timeFrame: Up to Day 28
measure: Number of Participants Discharged Alive From the ICU
timeFrame: Up to Day 28
measure: Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
timeFrame: Up to Day 28
measure: Duration of Mechanical Ventilation
timeFrame: Up to Day 28
measure: Duration of Hospitalization
timeFrame: Up to Day 28
measure: PaO2:FiO2 Ratio
timeFrame: Baseline, Day 7, Day 14, Day 21 and Day 28
measure: Number of Participants With Adverse Events
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: St Jude Medical Center
state: California
city: Washington
country: United States
facility: Medstar Heath Research Institute Medstar Washington Hospital Center
state: District of Columbia
city: Thomasville
country: United States
facility: John D Archbold Memorial Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: The Brigham and Womens Hospital, Inc
state: Massachusetts
city: Newark
country: United States
facility: Rutgers University Hospital
state: New Jersey
city: Houston
country: United States
facility: Therapeutics Concepts
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References: