Phase 2
N=63
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
COVID-19 Pulmonary Complications · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04382586 ↗Enrolled (actual)
63
Serious AEs
18.6%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Respiratory Failure-free Survival — 27; 28 Participants — p=0.4099
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zanubrutinib (Drug); Supportive Care (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Respiratory Failure-free Survival |
27; 28 | 0.4099 |
| PRIMARY Time to Breathing Room Air |
0.060; 0.061 | 0.7619 |
| SECONDARY Number of Participants Experiencing Respiratory Failure or Death |
3; 5 | — |
| SECONDARY Number of Participants With All-cause Mortality |
2; 4 | — |
| SECONDARY Number of Participants Discharged Alive |
26; 28 | — |
| SECONDARY Number of Participants Discharged Alive From the ICU |
3; 2 | — |
| SECONDARY Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale |
22; 25 | — |
| SECONDARY Duration of Mechanical Ventilation |
4.0; 13.5 | — |
| SECONDARY Duration of Hospitalization |
6.5; 5.0 | — |
| SECONDARY PaO2:FiO2 Ratio |
53.0; 82.00; 54.00; 32.00; 90.60; 52.10 | — |
| SECONDARY Number of Participants With Adverse Events |
19; 20; 6; 6; 4; 7 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT04382586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.