Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV... | NCT04551898

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BGB-DXP593 Low Dose	Experimental	Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days	Drug: BGB-DXP593
BGB-DXP593 Medium Dose	Experimental	Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days	Drug: BGB-DXP593
BGB-DXP593 High Dose	Experimental	Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days	Drug: BGB-DXP593
Placebo	Placebo Comparator	Participants will receive placebo on Day 1, and followed up for safety for up to 85 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGB-DXP593	Drug	Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm	BGB-DXP593 High Dose BGB-DXP593 Low Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding	SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.	Baseline and Day 8

Secondary Outcomes

Measure	Description	Time Frame
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15		Baseline and Day 15
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15	SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples

Eligibility Module

Name	Affiliation	Role
Study Director	BeiGene	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Btc Network Midland Florida Clinical Research Center		DeLand	Florida	32720	United States
Elixia Clinical Research Collaborative

PubMed Identifier	Type	Citation	Retractions
36820098	Derived	Vega R, Antila M, Perez C, Mookadam M, Xie F, Zhang W, Rizwan A, Yao Z, Rasko JEJ. SARS-CoV-2-neutralising antibody BGB-DXP593 in mild-to-moderate COVID-19: a multicentre, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2023 Mar;57:101832. doi: 10.1016/j.eclinm.2023.101832. Epub 2023 Feb 16.
34473343	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
FG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 milligrams/kilogram (mg/kg) DXP593 administered for 30 to 90 minutes

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 27, 2020	Feb 25, 2022

Arm/Group Information

ID	Title	Description
BG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
BG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
BG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
BG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding

SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.

Intent To Treat (ITT) analysis set. Participants with available data were included in the analysis.

Posted

Mean

Standard Deviation

log10 copies/ml

Baseline and Day 8

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes

Units	Counts
Participants	OG00041 OG00142 OG00234 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.88± 2.241 OG001-3.52± 2.831 OG002-3.75± 2.513 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.4829		Least square Mean	-0.25			2-Sided	90	-0.84	0.34					Superiority
OG000 OG002		Mixed Models Analysis		0.1739

Secondary

Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15

ITT analysis set. Participants with available samples were included in the analysis.

Posted

Mean

Standard Deviation

log10 copies/ml

Baseline and Day 15

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes

Units	Counts

Secondary

Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15

SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples

ITT analysis set. Participants with available samples were included in the analysis.

Posted

Mean

Standard Deviation

log10 copies/ml

Baseline and Day 15

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes

Secondary

Time to Negative RT-qPCR in All Tested Samples

The negative RT-qPCR is defined as the value that is below the lower limit of detection

ITT analysis set

Posted

Median

90% Confidence Interval

Days

From Baseline up to Day 21

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units

Secondary

Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19

ITT analysis set

Posted

Number

Percentage of participants

Baseline up to End of Study (EOS) /174 Days

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants

Secondary

Time to Resolution of All COVID-19-Related Symptoms

ITT analysis set

Posted

Median

90% Confidence Interval

Days

Baseline up to EOS /174 Days

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants

Secondary

All-Cause Mortality at Day 29

Number of participants that died by Day 29

ITT analysis set

Posted

Number

Percentage of participants

Day 29

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Safety analysis set includes all participants who received the study drug or placebo.

Posted

Number

Number of participants

Up to 174 days

ID	Title	Description
OG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes
OG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts

Secondary

Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593

Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Mean

Standard Deviation

µg/mL

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29

PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

day*μg/mL

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593

AUClast : AUC from time zero to the time of the last quantifiable concentration AUCinf: AUC from zero to infinite time with extrapolation of the terminal phase

PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

day*μg/mL

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants

Secondary

Time to Reach Cmax (Tmax) of BGB-DXP593

Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

hours

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Terminal Half-Life (t1/2) of BGB-DXP593

Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

Day

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Clearance (CL) of BGB-DXP593

Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

Liters/Day

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593

Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.

Posted

Median

Full Range

Liters

Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants	OG000

Secondary

Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593

The ADA Analysis Set includes all the participants who have received the study drug and in whom both baseline ADA and at least 1 postbaseline ADA results are available

Posted

Number

Number of participants

Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)

ID	Title	Description
OG000	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes
OG001	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes
OG002	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Single intravenous infusion of placebo solution administered over 30 to 90 minutes	1	47	2	47	5	47
EG001	BGB-DXP593 5 mg/kg	Single intravenous infusion of 5 mg/kg DXP593 administered for 30 to 90 minutes	0	44	2	44	4	44
EG002	BGB-DXP593 15 mg/kg	Single intravenous infusion of 15 mg/kg DXP593 administered for 30 to 90 minutes	0	40	1	40	4	40
EG003	BGB-DXP593 30 mg/kg	Single intravenous infusion of 30 mg/kg DXP593 administered for 30 to 90 minutes	0	45	0	45	7	45

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	meddra 24.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected44 at risk EG0020 events0 affected40 at risk EG0030 events0 affected45 at risk
Ear pruritus	Ear and labyrinth disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Diarrhoea	Gastrointestinal disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Gastritis	Gastrointestinal disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected44 at risk EG0020 events0 affected40 at risk EG003
Nausea	Gastrointestinal disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected44 at risk EG0020 events0 affected40 at risk EG003
Vomiting	Gastrointestinal disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Medical device site hypersensitivity	General disorders	meddra 24.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Urinary tract infection	Infections and infestations	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0021 events1 affected40 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Alanine aminotransferase increased	Investigations	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0021 events1 affected40 at risk EG003
Aspartate aminotransferase increased	Investigations	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0021 events1 affected40 at risk EG003
Fibrin D dimer increased	Investigations	meddra 24.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	meddra 24.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	meddra 24.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Dizziness	Nervous system disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0021 events1 affected40 at risk EG003
Dysgeusia	Nervous system disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003
Headache	Nervous system disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0021 events1 affected40 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	meddra 24.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected44 at risk EG0020 events0 affected40 at risk EG003

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases