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CompletedNCT06038916Updated Jul 11, 2025

To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

A Phase 1/2 interventional study of STSA-1002 Injection Placebo and STSA-1002 Injection in Acute Respiratory Distress Syndrome, sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd. Completed at 30 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 years old≤Age≤85 years old;
  2. Pathogen results indicate respiratory viral infection;
  3. Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
  4. In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
  5. PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
  6. Most recent peripheral blood lymphocyte count ≤0.8×10\^9/L prior to randomization;
  7. Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
  8. Willing to participate in the study and signs the informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Use of ECMO before the first administration;
  2. More than 48 hours of invasive mechanical ventilation prior to the first dose;
  3. Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
  4. Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
  5. Recent history of stroke or acute coronary syndrome;
  6. Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
  7. Suspected or known cytomegalovirus infection;
  8. Suspected or known active tuberculosis;
  9. Experienced prolonged fluid resuscitation-resistant septic shock.
  10. Severe chronic respiratory failure;
  11. Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
  12. Cardiogenic pulmonary edema or congestive heart failure;
  13. Liver dysfunction;
  14. Severe renal impairment or long-term dialysis;
  15. Immunocompromised state;
  16. A Absolute neutrophil count is excessively low;
  17. Severe anemia or active bleeding;
  18. Poor compliance with standard treatment;
  19. Pregnant or breastfeeding women;
  20. Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;
  21. Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
  22. Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
  23. Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Placebo comparator
    Placebo group

    Patients in this group will receive basal treatment and placebo.

    Drug: STSA-1002 Injection Placebo

  • Experimental
    Low dose group

    Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.

    Drug: STSA-1002 Injection Placebo · Drug: STSA-1002 Injection

  • Experimental
    High dose group

    Patients in this group will receive basal treatment and High-dose STSA-1002.

    Drug: STSA-1002 Injection

Interventions

  • DrugSTSA-1002 Injection Placebo

    Intravenous infusion

  • DrugSTSA-1002 Injection

    Intravenous infusion

06

What researchers measure

Primary outcomes

  1. Clinical remission time

    Time frame: Baseline to Day28

Secondary outcomes

  1. 28-day all-cause mortality rate

    Time frame: Day28 after first dose

  2. Proportion of subjects achieving clinical remission on Day 14 and Day 28

    Time frame: Day14, Day28 after first dose

  3. Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14

    Time frame: Day3, Day5, Day7, Day10, Day14 after first dose

  4. Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14

    Time frame: Day3, Day5, Day7, Day10, Day14 after first dose

  5. Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28

    Time frame: Day28 after first dose

  6. ICU length of stay and total hospitalization time on Day 28 (V10)

    Time frame: Day28 after first dose

  7. Proportion of subjects discharged from the ICU on Day 28

    Time frame: Day28 after first dose

  8. Proportion of subjects with PaO2/FiO2 > 300 mmHg on Day 28±2 (V10)

    Time frame: Day28 after first dose

  9. Time without ventilator use (invasive or non-invasive) within 28 days

    Time frame: Day28 after first dose

  10. Proportion of subjects alive and not receiving mechanical ventilation on Day 28

    Time frame: Day28 after first dose

07

Study locations

30 sites
  • The First Affiliated Hospital of Bengbu Medical University
    Bengbu, Anhui 233099, China
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
  • Beijing Luhe Hospital affiliated to Capital Medical University
    Beijing, Beijing Municipality 101199, China
  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
    Chongqing, Chongqing Municipality 400038, China
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong 518036, China
  • The People's Hospital of Guangxi Zhuang Autonomous Region
    Nanning, Guangxi 530016, China
  • The Second Hospital of Hebei Medical University City:Shijiazhuang
    Shijiazhuang, Hebei 050011, China
  • Huaihe Hospital of Henan University
    Kaifeng, Henan 450001, China
  • Kaifeng Central Hospital
    Kaifeng, Henan 475000, China
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 471099, China
  • The First Affiliated Hospital of Xinxiang Medical College
    Xingxiang, Henan 453100, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450003, China
  • Wuhan Jinyintan Hospital
    Wuhan, Hubei 430048, China
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430062, China
  • Xiangtan Central Hospital
    Xiangtan, Hunan 411100, China
  • Zhongda Hospital affiliated to Southeast University
    Nanjing, Jiangsu 210009, China
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
  • Qingdao Municipal Hospital
    Qingdao, Shandong 266071, China
  • Zibo Municipal Hospital
    Zibo, Shandong 255000, China
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200001, China
  • Shanxi Bethune Hospital
    Taiyuan, Shanxi 030032, China
  • The First Affiliated Hospital of Xi 'an Jiaotong University
    Xi’an, Shanxi 710061, China
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
  • The First Affiliated Hospital of Chengdu Medical College
    Chengdu, Sichuan 610599, China
  • Chengdu Fifth People's Hospital
    Chengdu, Sichuan 611130, China
  • Hangzhou Red Cross Hospital
    Hangzhou, Zhejiang 310003, China
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325035, China
08

References and documents

Publications

  • Wang Y, Huang X, Cheng Z, Chu Z, Li H, Zhang Y, Jiang M, Gan X, Li L, Yang X, Zhang Z, Suo L, Li Y, Huang X, Wang X, Yun S, Xiang X, Li Z, Cao B. Anti-C5a antibody STSA-1002 for patients with acute respiratory distress syndrome due to viral pneumonia: a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial. Chest. 2026 May 15:S0012-3692(26)00638-0. doi: 10.1016/j.chest.2026.04.052. Online ahead of print. PubMed 42142803 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06038916
Lead sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Dec 9, 2023
Primary completion
Mar 20, 2025
Completion
Apr 27, 2025
Last update
Jul 11, 2025

Study contacts

Bin Cao, Ph.D
principal investigator · China-Japan Friendship Hospital

Oversight

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

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