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Shen-Fu injection in the treatment of severe novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial

Shen-Fu injection in the treatment of severe novel coronavirus pneumonia (COVID-19): a multicenter, randomized, open-label, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030043
Enrollment
Unknown
Registered
2020-02-21
Start date
2020-02-21
Completion date
Unknown
Last updated
2020-02-25

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

Experimental:Conventional treatment and Shenfu injection

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed and suspected cases of pneumonia from novel coronavirus infection; 2. Meet the diagnostic criteria for community - acquired pneumonia; 3. Clinical classification is "heavy" or "critical"; 4. Aged 18 to 75 years; 5. Obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactating women; 2. People with allergies or allergies to Shenfu injection and its components; 3. Severe basic diseases that affect survival, including: uncontrolled malignant tumors with multiple metastases that cannot be removed, hematological diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.; 4. Obstructive pneumonia caused by lung tumors, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic reaction alveolitis; 5. Previous immunosuppressive agents within 6 months before study entry or recipients of a solid-organ or bone marrow transplant; 6. Extracorporeal life support (ECMO, ECCO2R, RRT); 7. Expected to die within 48 hours; 8. Patients who are considered by the investigator to be unsuitable subjects for this study.

Design outcomes

Primary

MeasureTime frame
pneumonia severity index (PSI);Incidence of new organ dysfunction;

Secondary

MeasureTime frame
28-day prognosis;SOFA;Mechanical ventilation time;Length of stay in ICU ;Total hospital expenses;Dosage of vasoactive drugs;

Countries

China

Contacts

Public ContactMa Penglin

Peking University Third Hospital

mapenglin1@163.com+86 13810339898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026