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CompletedNCT04551898Updated Oct 26, 2024Results posted

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

A Phase 2 interventional study of BGB-DXP593 and Placebo in Covid19, sponsored by BeiGene. Completed at 18 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by BeiGene · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19

02

Conditions studied

  • Covid19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 181 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection (positive reverse transcription-polymerase chain reaction [RT-PCR] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening.
  2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia
  3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Key Exclusion Criteria:

  1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \< 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min
  2. Requires mechanical ventilation or anticipated impending need for mechanical ventilation
  3. Known allergies to any of the components used in the formulation of the interventions
  4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    BGB-DXP593 Low Dose

    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

    Drug: BGB-DXP593

  • Experimental
    BGB-DXP593 Medium Dose

    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

    Drug: BGB-DXP593

  • Experimental
    BGB-DXP593 High Dose

    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

    Drug: BGB-DXP593

  • Placebo comparator
    Placebo

    Participants will receive placebo on Day 1, and followed up for safety for up to 85 days

    Drug: Placebo

Interventions

  • DrugBGB-DXP593

    Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

  • DrugPlacebo

    Placebo to match BGB-DXP593 administered as specified in the treatment arm

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Day 8

Secondary outcomes

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

    Time frame: Baseline and Day 15

  2. 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

    Time frame: Baseline and Day 15

  3. 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

    Time frame: From Baseline up to Day 21

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

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

  5. Time to Resolution of All COVID-19-Related Symptoms

    Time frame: Baseline up to EOS /174 Days

  6. All-Cause Mortality at Day 29

    Number of participants that died by Day 29

    Time frame: Day 29

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

    Time frame: Up to 174 days

  8. Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593

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

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

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

  10. 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

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

  11. Time to Reach Cmax (Tmax) of BGB-DXP593

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

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

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

  13. Clearance (CL) of BGB-DXP593

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

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

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

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

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

07

Results

Posted Mar 17, 2022

Participant flow

This study was conducted in 20 centers and 181 participants were treated.

Participant flow — Overall Study
MilestonePlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Started47454346
Completed39423541
Not completed8385
Withdrew: Participant randomized but did not receive study drug0131
Withdrew: Withdrawal by subject5122
Withdrew: Lost to follow-up2122
Withdrew: Death1000
Withdrew: Incorrectly randomized and screen failed due to administrative error0010

Outcome measures

PrimaryChange 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.

Time frame:
Baseline and Day 8
Reported as:
Mean · log10 copies/ml
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
log10 copies/mlPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding-2.88 ± 2.241-3.52 ± 2.831-3.75 ± 2.513-3.03 ± 2.239
Statistical analysis
  • Placebo vs BGB-DXP593 5 mg/kg · Mixed Models Analysis · p = 0.4829 · Least square mean: -0.25 · 90% CI -0.84 to 0.34
  • Placebo vs BGB-DXP593 15 mg/kg · Mixed Models Analysis · p = 0.1739 · Least square mean: -0.51 · 90% CI -1.13 to 0.11
  • Placebo vs BGB-DXP593 30 mg/kg · Mixed Models Analysis · p = 0.6006 · Least square mean: 0.19 · 90% CI -0.40 to 0.77
  • Placebo vs BGB-DXP593 5 mg/kg vs BGB-DXP593 15 mg/kg vs BGB-DXP593 30 mg/kg · t-test, 1 sided · p = 0.4996 (H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups)MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.
SecondaryTime-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Time frame:
Baseline and Day 15
Reported as:
Mean · log10 copies/ml
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
log10 copies/mlPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15-2.56 ± 1.718-2.93 ± 1.997-2.87 ± 2.049-2.55 ± 1.785
SecondaryChange 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

Time frame:
Baseline and Day 15
Reported as:
Mean · log10 copies/ml
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
log10 copies/mlPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15-4.16 ± 2.446-4.29 ± 2.675-4.31 ± 2.851-4.04 ± 2.577
SecondaryTime 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

Time frame:
From Baseline up to Day 21
Reported as:
Median · Days
Time to Negative RT-qPCR in All Tested Samples
DaysPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Time to Negative RT-qPCR in All Tested Samples17.00 (15.00 to 19.00)15.00 (13.00 to 17.00)10.00 (8.00 to 16.00)17.00 (15.00 to 17.00)
SecondaryPercentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time frame:
Baseline up to End of Study (EOS) /174 Days
Reported as:
Number · Percentage of participants
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Percentage of participantsPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-194.32.22.30.0
SecondaryTime to Resolution of All COVID-19-Related Symptoms
Time frame:
Baseline up to EOS /174 Days
Reported as:
Median · Days
Time to Resolution of All COVID-19-Related Symptoms
DaysPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Time to Resolution of All COVID-19-Related Symptoms16.5 (14.00 to 22.00)15.0 (14.00 to 22.00)19.0 (15.00 to 22.00)14.0 (9.00 to 16.00)
SecondaryAll-Cause Mortality at Day 29

Number of participants that died by Day 29

Time frame:
Day 29
Reported as:
Number · Percentage of participants
All-Cause Mortality at Day 29
Percentage of participantsPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
All-Cause Mortality at Day 292.13000
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame:
Up to 174 days
Reported as:
Number · Number of participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participantsPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
With at Least One TEAE6647
Grade 3 or Higher TEAE1110
Serious TEAE2210
SecondaryMaximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Reported as:
Mean · µg/mL
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
µg/mLBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593132.95 ± 53.180368.22 ± 232.040714.17 ± 149.198
SecondaryArea Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Reported as:
Median · day*μg/mL
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
day*μg/mLBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 291188.7 (620 to 3540)3014.3 (1198 to 4159)6609.2 (4345 to 8989)
SecondaryArea 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

Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Reported as:
Median · day*μg/mL
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
day*μg/mLBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
AUClast1829.3 (843 to 4491)4707.5 (406 to 6883)10259.5 (5165 to 16198)
AUCInf2098.7 (851 to 4564)4996.3 (2065 to 7351)10509.2 (5816 to 17245)
SecondaryTime to Reach Cmax (Tmax) of BGB-DXP593
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Reported as:
Median · hours
Time to Reach Cmax (Tmax) of BGB-DXP593
hoursBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Time to Reach Cmax (Tmax) of BGB-DXP5931.500 (0.75 to 322.72)1.500 (0.73 to 35.50)1.500 (0.83 to 34.25)
SecondaryTerminal Half-Life (t1/2) of BGB-DXP593
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Reported as:
Median · Day
Terminal Half-Life (t1/2) of BGB-DXP593
DayBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Terminal Half-Life (t1/2) of BGB-DXP59321.4 (15 to 40)23.2 (15 to 32)20.8 (14 to 32)
SecondaryClearance (CL) of BGB-DXP593
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Reported as:
Median · Liters/Day
Clearance (CL) of BGB-DXP593
Liters/DayBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Clearance (CL) of BGB-DXP5930.21 (0.1 to 0.5)0.25 (0.2 to 0.5)0.24 (0.1 to 0.4)
SecondaryVolume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Time frame:
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Reported as:
Median · Liters
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
LitersBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP5936.58 (2.5 to 11.9)8.07 (5.2 to 18.9)7.33 (3.3 to 11.6)
SecondaryNumber of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Time frame:
Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)
Reported as:
Number · Number of participants
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Number of participantsBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
Treatment Induced100
Neutralizing antibody Positive000

Adverse events

Collected over Up to 174 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo1/47 (2.1%)2/47 (4.3%)5/47 (10.6%)
BGB-DXP593 5 mg/kg0/44 (0%)2/44 (4.5%)4/44 (9.1%)
BGB-DXP593 15 mg/kg0/40 (0%)1/40 (2.5%)4/40 (10%)
BGB-DXP593 30 mg/kg0/45 (0%)0/45 (0%)7/45 (15.6%)
Most frequent serious events
Most frequent serious events
EventPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
COVID-19 pneumoniaInfections and infestations2/472/441/400/45
Most frequent other events
Showing 10 of 18
Most frequent other events
EventPlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kg
NauseaGastrointestinal disorders0/472/440/403/45
Urinary tract infectionInfections and infestations0/470/441/400/45
Alanine aminotransferase increasedInvestigations0/470/441/400/45
Aspartate aminotransferase increasedInvestigations0/470/441/400/45
DizzinessNervous system disorders0/470/441/400/45
HeadacheNervous system disorders0/470/441/401/45
TachycardiaCardiac disorders1/471/440/400/45
GastritisGastrointestinal disorders0/471/440/400/45
Ear pruritusEar and labyrinth disorders0/470/440/401/45
DiarrhoeaGastrointestinal disorders0/470/440/401/45

Baseline characteristics

Intent to treat (ITT) analysis set includes all randomized participants.

Age, Continuous
Age, Continuous(years)PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kgTotal
Mean44.3 ± 14.0246.2 ± 15.5643.6 ± 12.4341.1 ± 13.3543.8 ± 13.91
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kgTotal
Female2017222786
Male2728211995
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboBGB-DXP593 5 mg/kgBGB-DXP593 15 mg/kgBGB-DXP593 30 mg/kgTotal
American Indian or Alaska Native32128
Asian01001
Native Hawaiian or Other Pacific Islander00000
Black or African American352515
White40353933147
More than one race00000
Unknown or Not Reported121610
08

Study locations

18 sites
  • Btc Network Midland Florida Clinical Research Center
    DeLand, Florida 32720, United States
  • Elixia Clinical Research Collaborative
    Hollywood, Florida 33023, United States
  • Homestead Associates in Research Inc
    Miami, Florida 33032, United States
  • Medical Research Center of Miami Ii, Inc
    Miami, Florida 33134, United States
  • Us Associates in Research
    Miami, Florida 33175, United States
  • Continental Research Network
    Miami, Florida 33187, United States
  • Orlando Health Ufhealth Cancer Center
    Orlando, Florida 32806, United States
  • Revive Research Institute
    Dearborn, Michigan 48126, United States
  • Revival Research Institute Farmington Hills
    Sterling Heights, Michigan 48313, United States
  • Amarillo Center For Clinical Research
    Amarillo, Texas 79124, United States
  • Panamerican Clinical Research Us Headquarters
    Brownsville, Texas 78520, United States
  • Hospital Das Clinicas Da Faculdade de Medicina de Botucatu
    Botucatu, 18618-687, Brazil
  • Fundacao Universidade de Caxias Do Sul
    Caxias do Sul, 95070-560, Brazil
  • Consultoria Medica E Pesquisa Clinica
    Sorcaba, 18040-425, Brazil
  • Hospital Cardiologica Aguascalientes
    Aguascalientes, 20230, Mexico
  • IECSI
    Monterrey, 64310, Mexico
  • Task Clinical Research Centre
    Cape Town, 7500, South Africa
  • Langeberg Clinical Trials
    Cape Town, 7570, South Africa
09

References and documents

Publications

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗

Study documents

  • Study protocol · Oct 27, 2020
  • Statistical analysis plan · Mar 4, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04551898
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Dec 2, 2020
Primary completion
May 25, 2021
Completion
May 25, 2021
Results posted
Mar 17, 2022
Last update
Oct 26, 2024

Study contacts

Study Director
principal investigator · BeiGene

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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