---
title: Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
nct_id: NCT04449588
overall_status: TERMINATED
phase: PHASE2, PHASE3
sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
study_type: INTERVENTIONAL
primary_condition: COVID-19 Pneumonia
countries: Bangladesh, China, India, Indonesia, Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04449588.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04449588"
ct_last_update_post_date: 2024-05-22
last_seen_at: "2026-05-12T06:15:00.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

**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

**NCT ID:** [NCT04449588](https://clinicaltrials.gov/study/NCT04449588)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 369
- **Lead Sponsor:** Staidson (Beijing) Biopharmaceuticals Co., Ltd
- **Collaborators:** Beijing Defengrui Biotechnology Co. Ltd
- **Conditions:** COVID-19 Pneumonia
- **Start Date:** 2020-07-23
- **Completion Date:** 2024-03-26
- **CT.gov Last Update:** 2024-05-22

## Brief 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. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old, both men or women.
2. 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:
   1. Respiratory distress, RR ≥ 30 times/min
   2. Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
   3. Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
   4. Pulmonary imaging shows lesion progression \> 50% within 24-48 hours.

   Symptoms,signs or chest imaging indicates ALI/ARDS;
3. Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
4. The informed consent form signed.

Exclusion Criteria:

Subject who meets any of the following criteria will be excluded from the trial:

1. 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.
2. 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.
3. Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
4. Subjects with hypersensitivity history to any ingredient contained in the drug.
5. A subject has used the following drugs within 2 weeks prior to screening procedures:

   * 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)
6. Pregnant or lactating woman.
7. Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
8. Any other circumstances that the investigator considers inappropriate for the participation in this study.
```

## Arms

- **Treatment group** (EXPERIMENTAL)
- **Control group** (EXPERIMENTAL)

## Interventions

- **BDB-001 Injection** (DRUG) — BDB-001 Injection+Conventional treatment
- **Conventional treatment** (OTHER) — Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.

## Primary Outcomes

- **Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline** _(time frame: Baseline to Day 28)_

## Secondary Outcomes

- **28-day all-cause mortality rate** _(time frame: Baseline to Day 28)_
- **Percentage of patients who progress to critical severe** _(time frame: Baseline to Day 28)_
- **Percentage of subjects achieving recovery in SpO2** _(time frame: Baseline to Day 28)_
- **Mean change of PaO2/FiO2** _(time frame: Baseline to Day 28)_
- **Mechanical ventilation time** _(time frame: Baseline to Day 28)_
- **Time of oxygen therapy** _(time frame: Baseline to Day 28)_
- **Change in inflammation indicators (CRP or IL-6 etc.) from baseline** _(time frame: Baseline to Day 28)_
- **Improvement in body temperature** _(time frame: Baseline to Day 28)_
- **Mean change from baseline in the clinical improvement based on ordinal scale recommended by the WHO R&D Blueprint during treatment period** _(time frame: Baseline to Day 28)_
- **Improvement at D3, 7, 11 & D14 based on ordinal scale recommended by the WHO R&D Blueprint during treatment period** _(time frame: Baseline，Day 3，Day 7，Day 11，Day 14)_
- **Time to get categories 1 to 4 in the 8-points ordinal scale** _(time frame: Baseline to Day 28)_
- **Time to attain an improvement of 1 point on the ordinal scale** _(time frame: Baseline to Day 28)_

## Locations (12)

- Asgar Ali Hospital, Dhaka, Bangladesh
- Bangladesh Specialized Hospital, Dhaka, Bangladesh
- Southwest Hospital Chongqing, Chongqing, Chongqing Municipality, China
- Noble Hospital Pvt Ltd, Nagpur, India
- Government Medical College and Hospital, Pune, India
- RSUD Cengkareng(Cengkareng General Hospital), Jakarta, Jakrata, Indonesia
- RSUD Pasar Minggu(Pasar Minggu General Hospital), Jakarta, Indonesia
- RSUP Persahabatan(Persahabatan General Hospital), Jakarta, Indonesia
- Hospital Universitario 12 De Octubre, Madrid, Spain
- Hospital Universitario Clínico San Carlos, Madrid, Spain
- Hospital Universitario de la Princesa, Madrid, Spain
- Hospital Universitario Fundación Díaz, Madrid, Spain

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.asgar ali hospital|dhaka||bangladesh` — added _(2026-05-12)_
- `locations.bangladesh specialized hospital|dhaka||bangladesh` — added _(2026-05-12)_
- `locations.southwest hospital chongqing|chongqing|chongqing municipality|china` — added _(2026-05-12)_
- `locations.noble hospital pvt ltd|nagpur||india` — added _(2026-05-12)_
- `locations.government medical college and hospital|pune||india` — added _(2026-05-12)_
- `locations.rsud cengkareng(cengkareng general hospital)|jakarta|jakrata|indonesia` — added _(2026-05-12)_
- `locations.rsud pasar minggu(pasar minggu general hospital)|jakarta||indonesia` — added _(2026-05-12)_
- `locations.rsup persahabatan(persahabatan general hospital)|jakarta||indonesia` — added _(2026-05-12)_
- `locations.hospital universitario 12 de octubre|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario clínico san carlos|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario de la princesa|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario fundación díaz|madrid||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04449588.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04449588*  
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