COVID-19 Pulmonary ComplicationsPhase 2NCT04382586
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
A Phase 2 study testing Zanubrutinib and Supportive Care in people with COVID-19 Pulmonary Complications and COVID-19, run by BeiGene at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pulmonary Complications, COVID-19
- What is being tested?
- Zanubrutinib and Supportive Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Jul 2020to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Brigham and Womens Hospital, Inc
Boston, Massachusetts, 02115
St Jude Medical Center
Fullerton, California, 92835
Therapeutics Concepts
Houston, Texas, 77004
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Rutgers University Hospital
Newark, New Jersey, 07103
John D Archbold Memorial Hospital
Thomasville, Georgia, 31792
Medstar Heath Research Institute Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
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.
- Conditions
- COVID-19 Pulmonary Complications, COVID-19
- Being tested
- Zanubrutinib, Supportive Care, Placebo
- Keywords
- Corona Virus, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111, Brukinsa
320 mg (4 x 80 mg) capsules administered orally once daily
Supportive CareDrug
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
PlaceboDrug
Placebo to match zanubrutinib
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib + Supportive Care | Experimental | Participants received zanubrutinib plus supportive care Receives: Drug: Zanubrutinib; Drug: Supportive Care |
| Placebo + Supportive Care | Active comparator | Participants received placebo plus supportive care alone Receives: Drug: Supportive Care; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 28
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.
Measured: Up to 7 months
Secondary outcomes (9)
Number of Participants Experiencing Respiratory Failure or Death
Number of participants experiencing respiratory failure or death on or before Day 28
Measured: Up to Day 28
Number of Participants With All-cause Mortality
Number of participants with all-cause mortality on or before Day 28
Measured: Up to Day 28
Number of Participants Discharged Alive
Number of participants discharged alive on or before Day 28
Measured: Up to Day 28
Number of Participants Discharged Alive From the ICU
Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Measured: Up to Day 28
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.
Measured: Up to Day 28
Duration of Mechanical Ventilation
Number of days on mechanical ventilation on or before Day 28
Measured: Up to Day 28
Duration of Hospitalization
Number of days hospitalized on or before Day 28
Measured: Up to Day 28
PaO2:FiO2 Ratio
Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Measured: Baseline, Day 7, Day 14, Day 21 and Day 28
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
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start6 Jul 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Principal investigator, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382586
- Sponsor's protocol ID
- BGB-3111-219
- Status last verified
- Oct 2024
- First submitted
- 7 May 2020
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Treon SP, Kotton CN, Park DJ, Moranzoni G, Lemvigh CK, Gathe JC Jr, Varughese TA, Barnett CF, Belenchia JM, Clark NM, Farber CM, Abid MB, Ahmed G, Patterson CJ, Guerrera ML, Soumerai JD, Chea VA, Carulli IP, Southard J, Li S, Wu CJ, Livak KJ, Holmgren E, Kim P, Shi C, Lin H, Ramakrishnan V, Ou Y, Olszewski S, Olsen LR, Keskin DB, Hunter ZR, Tankersley C, Zimmerman T, Dhakal B. A randomized, placebo-controlled trial of the BTK inhibitor zanubrutinib in hospitalized patients with COVID-19 respiratory distress: immune biomarker and clinical findings. Front Immunol. 2025 Jan 21;15:1369619. doi: 10.3389/fimmu.2024.1369619. eCollection 2024.
PubMed 39906744
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
- ClinicalTrials.gov ID
- NCT04382586
- Acronym / sponsor ID
- BGB-3111-219
- Conditions
- COVID-19 Pulmonary Complications, COVID-19
- Keywords
- Corona Virus, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib + Supportive Care | Experimental | Drug: Zanubrutinib, Drug: Supportive CareParticipants received zanubrutinib plus supportive care |
| Placebo + Supportive Care | Active comparator | Drug: Supportive Care, Drug: PlaceboParticipants received placebo plus supportive care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: BGB-3111, Brukinsa320 mg (4 x 80 mg) capsules administered orally once daily | Drug | Zanubrutinib + Supportive Care |
| Supportive CareSupportive care treatment was selected and administered as deemed appropriate by the study investigator | Drug | Placebo + Supportive Care, Zanubrutinib + Supportive Care |
| PlaceboPlacebo to match zanubrutinib | Drug | Placebo + Supportive Care |
Primary outcome
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
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.
9 secondary outcomes
Number of Participants Experiencing Respiratory Failure or Death
Time frame: Up to Day 28
Number of Participants With All-cause Mortality
Time frame: Up to Day 28
Number of Participants Discharged Alive
Time frame: Up to Day 28
Number of Participants Discharged Alive From the ICU
Time frame: Up to Day 28
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
Time frame: Up to Day 28
Duration of Mechanical Ventilation
Time frame: Up to Day 28
Duration of Hospitalization
Time frame: Up to Day 28
PaO2:FiO2 Ratio
Time frame: Baseline, Day 7, Day 14, Day 21 and Day 28
Number of Participants With Adverse Events
Time frame: Up to 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39906744Treon SP, Kotton CN, Park DJ, Moranzoni G, Lemvigh CK, Gathe JC Jr, Varughese TA, Barnett CF, Belenchia JM, Clark NM, Farber CM, Abid MB, Ahmed G, Patterson CJ, Guerrera ML, Soumerai JD, Chea VA, Carulli IP, Southard J, Li S, Wu CJ, Livak KJ, Holmgren E, Kim P, Shi C, Lin H, Ramakrishnan V, Ou Y, Olszewski S, Olsen LR, Keskin DB, Hunter ZR, Tankersley C, Zimmerman T, Dhakal B. A randomized, placebo-controlled trial of the BTK inhibitor zanubrutinib in hospitalized patients with COVID-19 respiratory distress: immune biomarker and clinical findings. Front Immunol. 2025 Jan 21;15:1369619. doi: 10.3389/fimmu.2024.1369619. eCollection 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director principal investigator
BeiGene
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib and Supportive Care in people with COVID-19 Pulmonary Complications and COVID-19, run by BeiGene at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Respiratory Failure-free Survival (time frame: Up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.