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Canceled by the investigator Clinical study of nebulized Xiyanping injection in the treatment of novel coronavirus pneumonia (COVID-19)

Clinical study of nebulized Xiyanping injection in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029756
Enrollment
Unknown
Registered
2020-02-12
Start date
2020-02-15
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

novel coronavirus pneumonia (COVID-19)

Interventions

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old <= age <= 60 years old at the time of screening; 2. Pharyngeal swabs, alveolar lavage fluid, or sputum specimens during screening showed that 2019-nCoV virus nucleic acid test results were positive for at least two of nCov-EP, nCov-NP, and nCovORF1ab, in line with the release of a new coronavirus infection by the National Health and Medical Commission Diagnostic criteria for confirmed cases in the pneumonia diagnosis and treatment plan (trial version 5); 3. The investigator determined that aerosolized inhalation treatment was appropriate, and volunteered to participate in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Chronic lung diseases requiring long-term oxygen therapy; 2. Long-term application of glucocorticoids due to underlying diseases; 3. Based on the researcher's judgment, previous or current diseases may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc.; Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory diseases affecting clinical trial evaluation, Chest CT confirmed that patients with severe pulmonary interstitial lesions, bronchiectasis and other underlying lung diseases; 4. Breastfeeding or pregnancy test result is positive during screening or test; 5. Allergic constitution (persons who are allergic to more than 2 types of substances), persons who are allergic to similar drugs in the past or those who are known to be allergic to the ingredients and auxiliary materials in the test drugs; 6. The investigator decides that it is not in the best interest of the subject to participate in the study, or that the subject has any situation in which the protocol cannot be fully followed.

Design outcomes

Primary

MeasureTime frame
vital signs (Body temperature, blood pressure, heart rate, breathing rate);Respiratory symptoms and signs (Lung sounds, cough, sputum);Etiology and laboratory testing;PaO2/SPO2;Liquid balance;Ventilator condition;Imaging changes;

Secondary

MeasureTime frame
Hemodiafiltration;Mechanical ventilation time;Application of pulmonary surfactant;Oxygen time (hours);ICU days;

Countries

China

Contacts

Public ContactZhan Zhang

Renmin Hospital of Wuhan University

doctorzhang2003@163.com+86 18062567610

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026