Acute Respiratory Distress Syndrome (ARDS)Phase 3NCT07208591
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
A Phase 3 study testing STSA-1002 injection in people with Acute Respiratory Distress Syndrome (ARDS), run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 15 sites in China.
Trial summary
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- STSA-1002 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 15 sitesChina
- Study dates
- 31 Oct 2025to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ ≤ 85 years old;
- laboratory tests results indicate respiratory viral infection;
- Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
- The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)/)/≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;
- PaO2/FiO2≤200mmHg;
- The subjects (including their partners) have no plans to have children during the trial and within 3 months after the last dose, and agree to take appropriate and effective contraceptive measures (such as contraceptive pills, condoms, etc.);
- Volunteer to participate in the trial and sign the informed consent form.
Who cannot join
- ECMO before the first dose;
- According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
- The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
- Patients with stroke or acute coronary syndrome within 3 months before randomization;
- Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
- Severe chronic respiratory failure;
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- Known active pulmonary tuberculosis;
- Combined with liver insufficiency
- Long-term dialysis and/or known severe renal impairment Cytomegalovirus infection;
- Known HIV infection with CD4+ T-lymphocyte count < 200 cells/μL;
- Organ transplant patients;
- Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;
- Septic shock
- Absolute neutrophil count is less than 0.5×109/L;
- Hemoglobin is less than 60g/L, or the researcher judges that there is active gastrointestinal bleeding;
- Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;
- 18. Participated in new drug clinical trials and medication within 3 months before screening; 19. Allergic or allergic to any component of the trial drug and its excipients (such as allergic to two or more drugs); 20. Other diseases or conditions that the investigator considers unsuitable for participation in this trial.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Bin Cao, 13911318339, caobin_ben@163.com
- Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xiaobo Huang, 18981838938, drhuangxb@163.com
- Recruiting
Dazhou Central Hospital
Dazhou, Sichuan, 635099
Pingfei Wang, 13079046669, 956565257@qq.com
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Yichun Wang, 18127945241, wangyichun2005@163.com
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 51063
Yifeng Luo, 13760796562, 13760796562@163.com
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Wei Hu, 13750890929, huwei@hospital.westlake.edu.cn
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471099
Yongmei Zhang, 13683861918, zzyymm666@sina.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xin Gan, 13576950369, ganxin1207@126.com
- Recruiting
Weifang People's Hospital
Weifang, Shandong, 261041
Bo Liu, 17660292456, 42820159@qq.com
- Recruiting
Wuhan Central Hospital
Wuhan, Hubei, 430014
Jixiang N, 13477838399, keamin77@163.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Yihua Lin, 13515968915, yhlin_xm@163.com
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
Mingyan Jiang, 13761128012, jiangmingyan@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xiaoju Zhang, 15837101166, 15837101166@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mengying Yao, 13592665719, ymy13592665719@163.com
- Recruiting
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Tao Chen, 15329112288, 2395086838@qq.com
About this study
Official title: Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
- Being tested
- STSA-1002 injection, STSA-1002 Injection Placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSA-1002 injectionDrug
basal treatment + STASA-1002 intravenous infusion
STSA-1002 Injection PlaceboDrug
basal treatment + STSA-1002 Injection Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in this group will receive basal treatment and STSA-1002. Receives: Drug: STSA-1002 injection |
| Placebo group | Placebo comparator | Patients in this group will receive basal treatment and STSA-1002. Receives: Drug: STSA-1002 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality rate
Measured: Day28 after first dose
Secondary outcomes (6)
60-day all-cause mortality rate
Measured: Day60 after first dose
Proportion of subjects with a decrease in the level of respiratory support on Day 28
Measured: Day28 after first dose
ICU length of stay and total hospitalization time on Day 28
Measured: Day28 after first dose
Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28
Measured: Day28 after first dose
Days alive without invasive mechanical ventilation
Measured: Day28 after first dose
Changes in SOFA values from baseline on Day 3, 7, 10, and 14
Measured: Day14 after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start31 Oct 2025
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin M.D. Cao, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208591
- Sponsor's protocol ID
- STSA-1002-07
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07208591
- Acronym / sponsor ID
- STSA-1002-07
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: STSA-1002 injectionPatients in this group will receive basal treatment and STSA-1002. |
| Placebo group | Placebo comparator | Drug: STSA-1002 Injection PlaceboPatients in this group will receive basal treatment and STSA-1002. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old ≤ ≤ 85 years old;
- laboratory tests results indicate respiratory viral infection;
- Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
- The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)/)/≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;
- PaO2/FiO2≤200mmHg;
Key exclusion criteria (17 listed)
- ECMO before the first dose;
- According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
- The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
- Patients with stroke or acute coronary syndrome within 3 months before randomization;
- Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STSA-1002 injectionbasal treatment + STASA-1002 intravenous infusion | Drug | Experimental group |
| STSA-1002 Injection Placebobasal treatment + STSA-1002 Injection Placebo | Drug | Placebo group |
Primary outcome
28-day all-cause mortality rate
Time frame: Day28 after first dose
6 secondary outcomes
60-day all-cause mortality rate
Time frame: Day60 after first dose
Proportion of subjects with a decrease in the level of respiratory support on Day 28
Time frame: Day28 after first dose
ICU length of stay and total hospitalization time on Day 28
Time frame: Day28 after first dose
Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28
Time frame: Day28 after first dose
Days alive without invasive mechanical ventilation
Time frame: Day28 after first dose
Changes in SOFA values from baseline on Day 3, 7, 10, and 14
Time frame: Day14 after first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin M.D. Cao principal investigator
China-Japan Friendship Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STSA-1002 injection in people with Acute Respiratory Distress Syndrome (ARDS), run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 15 sites in China.
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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in 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. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aiping Sun (+8618611103198, sunaiping@staidson.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality rate (time frame: Day28 after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.