Single-dose inhaled rh-KGF-2 for ARDS in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, randomized, open-label study will give a single inhaled dose of lyophilized rh-KGF-2 to adults with moderate to severe ARDS already on standard care. Three sequential dose groups (5 mg, 10 mg, 15 mg) enroll eight patients each, with six receiving the drug and two receiving a blank control, delivered via a disposable bronchoscopic catheter. Patients are followed for 28 days to monitor safety, tolerability, oxygenation, imaging changes, and other clinical outcomes. The trial is conducted on top of standard ARDS therapies to evaluate the safety profile and potential signals of efficacy of rh-KGF-2 in this setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥18 years and \<80 years, male or female.
2. Definite diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition.
3. Patients with PaO₂/FiO₂ \< 200 mmHg and receiving invasive mechanical ventilation via endotracheal intubation.
4. Diagnosis of ARDS confirmed no more than 72 hours prior to enrollment.
5. No plan for parenthood within 1 year and agree to take effective contraceptive measures during the study period. Female participants of childbearing potential must have a negative serum pregnancy test.
6. The subject fully understands the purpose of the study, as well as the nature, methods, and potential reactions of the investigational drug. The subject voluntarily signs the informed consent form to participate in the study and agrees to comply with the requirements of the study protocol. If the subject is unable to provide consent or has limited capacity to consent, consent must be obtained from the subject's legal guardian.

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Exclusion Criteria:

1. Use of inhaled pulmonary vasodilators (e.g., nitric oxide or prostaglandins).
2. Current receipt or planned receipt of extracorporeal membrane oxygenation (ECMO) during the study period.
3. Expected survival \< 3 months due to causes other than respiratory failure.
4. Cerebrovascular or cardiovascular events within 3 months prior to study drug administration, including unstable angina, congestive heart failure, myocardial infarction within the past 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) \< 40%, or clinically significant arrhythmia or conduction abnormality.
5. Inability to tolerate single-use bronchoscopic imaging catheter examination, including but not limited to the following: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction or unstable angina within 4-6 weeks prior to screening; severe cardiac dysfunction; uncorrectable bleeding tendency (platelet count \< 60 × 10⁹/L), such as severe coagulation disorders, uremia, or severe pulmonary hypertension; severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae.
6. History of severe allergic reaction, or known allergy or hypersensitivity to any component of the investigational product.
7. Breastfeeding or pregnant women.
8. Participation in any drug clinical trial within 3 months prior to enrollment.
9. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.

Where it's running

• ShanghaiZhongshan
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jing Bi — Shanghai Zhongshan Hospital
• Study coordinator: Yi Wei
• Email: yiwei4075@163.com
• Phone: +86 18872984075

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transpulmonary Pressure-Guided Ventilation for Right Heart Protection in ARDS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.