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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382586
Recruitment Status : Completed
First Posted : May 11, 2020
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions COVID-19 Pulmonary Complications
COVID-19
Interventions Drug: Zanubrutinib
Drug: Supportive Care
Drug: Placebo
Enrollment 63
Recruitment Details A total of 63 participants were randomized to receive zanubrutinib or placebo; four were randomized to the placebo group, but did not receive placebo treatment due to death (1 participant) and investigator decision (3 participants).
Pre-assignment Details  
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator. Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Period Title: Overall Study
Started 30 33
Completed 13 17
Not Completed 17 16
Reason Not Completed
Death             3             4
Lost to Follow-up             11             8
Withdrawal by Subject             3             1
Physician Decision             0             3
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care Total
Hide Arm/Group Description Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator. Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator. Total of all reporting groups
Overall Number of Baseline Participants 30 33 63
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 33 participants 63 participants
56.0  (12.51) 56.0  (13.30) 56.0  (12.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Female 16 16 32
Male 14 17 31
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Hispanic or Latino 13 6 19
Not Hispanic or Latino 16 26 42
Unknown or Not Reported 1 1 2
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Asian
2
   6.7%
2
   6.1%
4
   6.3%
Black or African American
3
  10.0%
5
  15.2%
8
  12.7%
White
19
  63.3%
25
  75.8%
44
  69.8%
Other
1
   3.3%
1
   3.0%
2
   3.2%
Unknown
3
  10.0%
0
   0.0%
3
   4.8%
Not Reported
2
   6.7%
0
   0.0%
2
   3.2%
1.Primary Outcome
Title Number of Participants With Respiratory Failure-free Survival
Hide Description Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Count of Participants
Unit of Measure: Participants
27
  90.0%
28
  84.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zanubrutinib + Supportive Care, Placebo + Supportive Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4099
Comments [Not Specified]
Method Unstratified 1-sided Fisher's exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
0.349 to 7.391
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to Breathing Room Air
Hide Description 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.
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Number
Unit of Measure: Events / total follow-up in days
0.060 0.061
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zanubrutinib + Supportive Care, Placebo + Supportive Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7619
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.918
Confidence Interval (2-Sided) 95%
0.511 to 1.648
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Experiencing Respiratory Failure or Death
Hide Description Number of participants experiencing respiratory failure or death on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.0%
5
  15.2%
4.Secondary Outcome
Title Number of Participants With All-cause Mortality
Hide Description Number of participants with all-cause mortality on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.7%
4
  12.1%
5.Secondary Outcome
Title Number of Participants Discharged Alive
Hide Description Number of participants discharged alive on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Count of Participants
Unit of Measure: Participants
26
  86.7%
28
  84.8%
6.Secondary Outcome
Title Number of Participants Discharged Alive From the ICU
Hide Description Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants; Here, overall number of participants analyzed represents participants who were admitted to the ICU and are evaluable for this outcome measure
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
3
  21.4%
2
  15.4%
7.Secondary Outcome
Title Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
Hide Description 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.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Measure Type: Count of Participants
Unit of Measure: Participants
22
  73.3%
25
  75.8%
8.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description Number of days on mechanical ventilation on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants, excluding participants who died before event completion; Here, overall number of participants analyzed represents participants who progressed from supplemental oxygen to mechanical ventilation and are evaluable for this outcome measure
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 3 4
Median (Full Range)
Unit of Measure: Days
4.0
(3 to 24)
13.5
(3 to 26)
9.Secondary Outcome
Title Duration of Hospitalization
Hide Description Number of days hospitalized on or before Day 28
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants, excluding participants who died before event completion
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 33
Median (Full Range)
Unit of Measure: Days
6.5
(3 to 28)
5.0
(1 to 28)
10.Secondary Outcome
Title PaO2:FiO2 Ratio
Hide Description Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Time Frame Baseline, Day 7, Day 14, Day 21 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Analysis Set included all randomized participants; Here, overall number of participants analyzed represents participants who progressed from supplemental oxygen to mechanical ventilation and are evaluable for this outcome measure and number analyzed represents participants with evaluable data at each time point
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 3 3
Median (Full Range)
Unit of Measure: mmHg
Baseline Number Analyzed 0 participants 1 participants
53.0
(53.0 to 53.0)
Day 7 Number Analyzed 2 participants 3 participants
82.00
(75.00 to 89.00)
54.00
(52.80 to 84.30)
Day 14 Number Analyzed 1 participants 1 participants
32.00
(32.00 to 32.00)
90.60
(90.60 to 90.60)
Day 21 Number Analyzed 0 participants 1 participants
52.10
(52.10 to 52.10)
Day 28 Number Analyzed 0 participants 0 participants
11.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description 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
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all participants who received any dose of study drug
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description:
Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
At least one TEAE 19 20
Grade 3 or higher 6 6
Serious adverse event 4 7
Treatment-related TEAE 2 1
Time Frame Up to 7 months
Adverse Event Reporting Description Serious and other (not including serious) adverse events are reported for the Safety Analysis Set, which includes all participants who received any dose of study drug. All-cause mortality is reported for all randomized participants.
 
Arm/Group Title Zanubrutinib + Supportive Care Placebo + Supportive Care
Hide Arm/Group Description Zanubrutinib 320 mg orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator. Placebo orally once daily for 28 days. Supportive care treatment selected and administered as deemed appropriate by the study investigator.
All-Cause Mortality
Zanubrutinib + Supportive Care Placebo + Supportive Care
Affected / at Risk (%) Affected / at Risk (%)
Total   3/30 (10.00%)      4/33 (12.12%)    
Hide Serious Adverse Events
Zanubrutinib + Supportive Care Placebo + Supportive Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/30 (13.33%)      7/29 (24.14%)    
Blood and lymphatic system disorders     
Anaemia  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Cardiac disorders     
Right ventricular failure  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations     
COVID-19 pneumonia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Septic shock  1  0/30 (0.00%)  0 0/29 (0.00%)  0
Metabolism and nutrition disorders     
Hypernatraemia  1  0/30 (0.00%)  0 0/29 (0.00%)  0
Nervous system disorders     
Haemorrhage intracranial  1  0/30 (0.00%)  0 0/29 (0.00%)  0
Ischaemic stroke  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/30 (3.33%)  1 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/30 (0.00%)  0 0/29 (0.00%)  0
Dyspnoea  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Hypoxia  1  1/30 (3.33%)  1 2/29 (6.90%)  2
Pulmonary embolism  1  1/30 (3.33%)  1 1/29 (3.45%)  1
Respiratory distress  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Respiratory failure  1  2/30 (6.67%)  2 2/29 (6.90%)  2
Vascular disorders     
Distributive shock  1  1/30 (3.33%)  1 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Zanubrutinib + Supportive Care Placebo + Supportive Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/30 (63.33%)      20/29 (68.97%)    
Blood and lymphatic system disorders     
Anaemia  1  1/30 (3.33%)  1 1/29 (3.45%)  1
Leukocytosis  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Pancytopenia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Thrombocytopenia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Bradycardia  1  5/30 (16.67%)  5 0/29 (0.00%)  0
Extrasystoles  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Sinus bradycardia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Sinus tachycardia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Tachycardia  1  1/30 (3.33%)  1 1/29 (3.45%)  1
Eye disorders     
Vision blurred  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Gastrointestinal disorders     
Ascites  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Constipation  1  2/30 (6.67%)  2 2/29 (6.90%)  2
Diarrhoea  1  2/30 (6.67%)  2 1/29 (3.45%)  1
Dyspepsia  1  1/30 (3.33%)  1 1/29 (3.45%)  1
Flatulence  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Gastric ulcer haemorrhage  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Nausea  1  2/30 (6.67%)  2 0/29 (0.00%)  0
Rectal haemorrhage  1  1/30 (3.33%)  1 0/29 (0.00%)  0
General disorders     
Fatigue  1  1/30 (3.33%)  1 0/29 (0.00%)  0
General physical health deterioration  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Oedema peripheral  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Peripheral swelling  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Hepatobiliary disorders     
Ischaemic hepatitis  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations     
Acute sinusitis  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Bacteraemia  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Cellulitis  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Epstein-Barr virus infection  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Herpes simplex  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Parotitis  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Pneumonia bacterial  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Sepsis  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Urinary tract infection  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Hepatic enzyme increased  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Lymphocyte count decreased  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Hyperglycaemia  1  2/30 (6.67%)  2 1/29 (3.45%)  1
Hypoalbuminaemia  1  1/30 (3.33%)  3 2/29 (6.90%)  4
Hypoglycaemia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Hypokalaemia  1  3/30 (10.00%)  3 1/29 (3.45%)  1
Hypomagnesaemia  1  0/30 (0.00%)  0 3/29 (10.34%)  3
Hypophagia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Hypophosphataemia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Vitamin D deficiency  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Groin pain  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Muscle spasms  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Pain in extremity  1  0/30 (0.00%)  0 2/29 (6.90%)  2
Rhabdomyolysis  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Nervous system disorders     
Headache  1  1/30 (3.33%)  1 3/29 (10.34%)  3
Intensive care unit acquired weakness  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Depression  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Renal and urinary disorders     
Haematuria  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Micturition urgency  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Reproductive system and breast disorders     
Vaginal haemorrhage  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Hypoxia  1  0/30 (0.00%)  0 2/29 (6.90%)  2
Nasal discomfort  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Oropharyngeal pain  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Pleuritic pain  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Pulmonary hypertension  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Wheezing  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Decubitus ulcer  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Rash macular  1  1/30 (3.33%)  1 0/29 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/30 (0.00%)  0 1/29 (3.45%)  1
Hypovolaemic shock  1  1/30 (3.33%)  1 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: BeiGene
Phone: +1-877-828-5568
EMail: clinicaltrials@beigene.com
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04382586    
Other Study ID Numbers: BGB-3111-219
First Submitted: May 7, 2020
First Posted: May 11, 2020
Results First Submitted: January 31, 2022
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022