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Covid19Phase 2NCT04551898

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 study testing BGB-DXP593 in people with Covid19, run by BeiGene at 18 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Covid19
What is being tested?
BGB-DXP593
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
18 sitesin 4 countries
Study dates
2 Dec 2020to 25 May 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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
  • Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Who cannot join

  • 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
  • Requires mechanical ventilation or anticipated impending need for mechanical ventilation
  • Known allergies to any of the components used in the formulation of the interventions
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  • Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

United States11 sites

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Panamerican Clinical Research Us Headquarters

    Brownsville, Texas, 78520

  • Revive Research Institute

    Dearborn, Michigan, 48126

  • Btc Network Midland Florida Clinical Research Center

    DeLand, Florida, 32720

  • Elixia Clinical Research Collaborative

    Hollywood, Florida, 33023

  • Homestead Associates in Research Inc

    Miami, Florida, 33032

  • Medical Research Center of Miami Ii, Inc

    Miami, Florida, 33134

  • Us Associates in Research

    Miami, Florida, 33175

  • Continental Research Network

    Miami, Florida, 33187

  • Orlando Health Ufhealth Cancer Center

    Orlando, Florida, 32806

  • Revival Research Institute Farmington Hills

    Sterling Heights, Michigan, 48313

Other trials in United States

Brazil3 sites

  • Hospital Das Clinicas Da Faculdade de Medicina de Botucatu

    Botucatu, 18618-687

  • Fundacao Universidade de Caxias Do Sul

    Caxias do Sul, 95070-560

  • Consultoria Medica E Pesquisa Clinica

    Sorcaba, 18040-425

Other trials in Brazil

Mexico2 sites

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • IECSI

    Monterrey, 64310

Other trials in Mexico

South Africa2 sites

  • Task Clinical Research Centre

    Cape Town, 7500

  • Langeberg Clinical Trials

    Cape Town, 7570

Other trials in South Africa

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Patients With Mild-to-Moderate COVID-19

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

Conditions
Covid19
Being tested
BGB-DXP593, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-DXP593Drug

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

  • PlaceboDrug

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

Study groups in NCT04551898
Study groupRoleWhat they receive
BGB-DXP593 Low DoseExperimentalParticipants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Receives: Drug: BGB-DXP593
BGB-DXP593 Medium DoseExperimentalParticipants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Receives: Drug: BGB-DXP593
BGB-DXP593 High DoseExperimentalParticipants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Receives: Drug: BGB-DXP593
PlaceboPlacebo comparatorParticipants will receive placebo on Day 1, and followed up for safety for up to 85 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Day 8

Secondary outcomes (15)

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

    Measured: 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

    Measured: 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

    Measured: From Baseline up to Day 21

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

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

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

    Measured: Baseline up to EOS /174 Days

  6. All-Cause Mortality at Day 29

    Number of participants that died by Day 29

    Measured: Day 29

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

    Measured: Up to 174 days

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start2 Dec 2020
  3. Primary completion25 May 2021
  4. Study completion25 May 2021

Resources

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
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551898
Sponsor's protocol ID
BGB-DXP593-102
Status last verified
Oct 2024
First submitted
10 Sep 2020
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 36820098

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGB-DXP593 in people with Covid19, run by BeiGene at 18 sites in 4 countries.

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 6 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 18 sites in United States, Brazil, Mexico, South Africa. 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. Some participants in this study may receive a placebo. 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 17 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?

Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding (time frame: Baseline and Day 8). 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 NCT04551898, which also lists 2 linked publications.

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.

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