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COVID-19 PneumoniaPhase 2/3NCT04449588

Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

A Phase 2/3 study testing BDB-001 Injection and Conventional treatment in people with COVID-19 Pneumonia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 12 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
BDB-001 Injection and Conventional treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
12 sitesin 5 countries
Study dates
23 Jul 2020to 26 Mar 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old ≤ age ≤ 80 years old, both men or women.
  • Confirmed SARS-CoV-2 infection, and meet at least one of the following criteria:
  • Confirmed severe COVID-19 in no more than 5 days who meets any of the following criteria:
  • Respiratory distress, RR ≥ 30 times/min
  • Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
  • Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
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  • Pulmonary imaging shows lesion progression > 50% within 24-48 hours.
  • Symptoms,signs or chest imaging indicates ALI/ARDS;
  • Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
  • The informed consent form signed.

Who cannot join

  • Subject who meets any of the following criteria will be excluded from the trial:
  • Subjects already progressed into critically severe COVID-19 Critical severe standards refer to FDA guidelines,as shown in Appendix 4 or sepsis and sepsis shock.
  • Concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (NYHA Classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. Child-Pugh score ≥ grade C); severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
  • Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
  • Subjects with hypersensitivity history to any ingredient contained in the drug.
  • A subject has used the following drugs within 2 weeks prior to screening procedures:
Show all 13Show fewer
  • Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
  • Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
  • Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
  • Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
  • Pregnant or lactating woman.
  • Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
  • Any other circumstances that the investigator considers inappropriate for the participation in this study.

Trial locations and contacts

12 sites in 5 countries.

12 sites in 5 countries

Spain4 sites

  • Hospital Universitario 12 De Octubre

    Madrid

  • Hospital Universitario Clínico San Carlos

    Madrid

  • Hospital Universitario de la Princesa

    Madrid

  • Hospital Universitario Fundación Díaz

    Madrid

Other trials in Spain

Indonesia3 sites

  • RSUD Cengkareng(Cengkareng General Hospital)

    Jakarta, Jakrata, 11730

  • RSUD Pasar Minggu(Pasar Minggu General Hospital)

    Jakarta, 12550

  • RSUP Persahabatan(Persahabatan General Hospital)

    Jakarta, 13230

Other trials in Indonesia

Bangladesh2 sites

  • Asgar Ali Hospital

    Dhaka

  • Bangladesh Specialized Hospital

    Dhaka

Other trials in Bangladesh

India2 sites

  • Noble Hospital Pvt Ltd

    Nagpur

  • Government Medical College and Hospital

    Pune

Other trials in India

China1 site

  • Southwest Hospital Chongqing

    Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Official title: A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).

Being tested
BDB-001 Injection, Conventional treatment
Keywords
COVID-19, Severe Pneumonia, ALI/ARDS
Medical subject headings
COVID-19, Pneumonia

What participants receive

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

  • BDB-001 InjectionDrug

    BDB-001 Injection+Conventional treatment

  • Conventional treatmentOther

    Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.

Study groups in NCT04449588
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Drug: BDB-001 Injection
Control groupExperimentalNot described
Receives: Other: Conventional treatment

What is being measured

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

  1. Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline

    Measured: Baseline to Day 28

Secondary outcomes (12)

  1. 28-day all-cause mortality rate

    Measured: Baseline to Day 28

  2. Percentage of patients who progress to critical severe

    Measured: Baseline to Day 28

  3. Percentage of subjects achieving recovery in SpO2

    Measured: Baseline to Day 28

  4. Mean change of PaO2/FiO2

    Measured: Baseline to Day 28

  5. Mechanical ventilation time

    Measured: Baseline to Day 28

  6. Time of oxygen therapy

    Measured: Baseline to Day 28

  7. Change in inflammation indicators (CRP or IL-6 etc.) from baseline

    Measured: Baseline to Day 28

  8. Improvement in body temperature

    Measured: Baseline to Day 28

  9. Mean change from baseline in the clinical improvement based on ordinal scale recommended by the WHO R&D Blueprint during treatment period

    Measured: Baseline to Day 28

  10. Improvement at D3, 7, 11 & D14 based on ordinal scale recommended by the WHO R&D Blueprint during treatment period

    Measured: Baseline，Day 3，Day 7，Day 11，Day 14

  11. Time to get categories 1 to 4 in the 8-points ordinal scale

    Measured: Baseline to Day 28

  12. Time to attain an improvement of 1 point on the ordinal scale

    Measured: Baseline to Day 28

Timeline

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

  1. First posted29 Jun 2020
  2. Study start23 Jul 2020
  3. Primary completion26 Mar 2024
  4. Study completion26 Mar 2024

Why it stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04449588
Sponsor's protocol ID
STS-BDB001-04
Status last verified
May 2024
First submitted
26 Jun 2020
Last updated
22 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo RF, Ward PA. Role of C5a in inflammatory responses. Annu Rev Immunol. 2005;23:821-52. doi: 10.1146/annurev.immunol.23.021704.115835.

    PubMed 15771587

  • Wood AJT, Vassallo A, Summers C, Chilvers ER, Conway-Morris A. C5a anaphylatoxin and its role in critical illness-induced organ dysfunction. Eur J Clin Invest. 2018 Dec;48(12):e13028. doi: 10.1111/eci.13028. Epub 2018 Oct 15.

    PubMed 30229880

  • Wang R, Xiao H, Guo R, Li Y, Shen B. The role of C5a in acute lung injury induced by highly pathogenic viral infections. Emerg Microbes Infect. 2015 May;4(5):e28. doi: 10.1038/emi.2015.28. Epub 2015 May 6.

    PubMed 26060601

  • Sun S, Zhao G, Liu C, Fan W, Zhou X, Zeng L, Guo Y, Kou Z, Yu H, Li J, Wang R, Li Y, Schneider C, Habel M, Riedemann NC, Du L, Jiang S, Guo R, Zhou Y. Treatment with anti-C5a antibody improves the outcome of H7N9 virus infection in African green monkeys. Clin Infect Dis. 2015 Feb 15;60(4):586-95. doi: 10.1093/cid/ciu887. Epub 2014 Nov 27.

    PubMed 25433014

  • Sun S, Zhao G, Liu C, Wu X, Guo Y, Yu H, Song H, Du L, Jiang S, Guo R, Tomlinson S, Zhou Y. Inhibition of complement activation alleviates acute lung injury induced by highly pathogenic avian influenza H5N1 virus infection. Am J Respir Cell Mol Biol. 2013 Aug;49(2):221-30. doi: 10.1165/rcmb.2012-0428OC.

    PubMed 23526211

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BDB-001 Injection and Conventional treatment in people with COVID-19 Pneumonia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 12 sites in 5 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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain, Indonesia, Bangladesh, India, China. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.). Results are not available in the source record.

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?

Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline (time frame: Baseline to Day 28). 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 NCT04449588, which also lists 5 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 22 May 2024.

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