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A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection in the treatment of novel coronavirus pneumonia (COVID-19)

A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003004
Enrollment
Unknown
Registered
2020-02-13
Start date
2020-02-14
Completion date
Unknown
Last updated
2023-02-20

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

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years; 2) In line with the diagnostic criteria of "new coronavirus pneumonia diagnosis program", the patient was diagnosed as pneumonia infected by the new coronavirus; 3) Severe pneumonia index (PSI) class for III ~ IV; 4) The course of symptoms should be less than or equal to 8 days; 5) Volunteers and comply with the hospital regulations, can cooperate with the completion of the prescribed inspection; 6) Voluntary informed consent was signed prior to the trial.

Exclusion criteria

Exclusion criteria: 1)One of the following conditions: Respiratory distress, RR >= 30 times/min; At rest, oxygen saturation is less than 93%; Artial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg (1mmHg=0.133kPa); Respiratory failure is present and mechanical ventilation is required; Shock; Combined with other organ failure requires intensive care unit; It is expected to be transferred to a non-study hospital within 72 hours. 2)Severe influenza and influenza patients with complications (such as secondary bacterial pneumonia, pneumonia caused by other pathogens and other viral pneumonia);Or the patient is hospitalized with severe influenza; 3)Patients with other upper respiratory tract infections: asthma requiring daily treatment, any other chronic respiratory diseases, respiratory bacterial infections such as suppurative tonsillitis, acute tracheal bronchitis, sinusitis, otitis media and other respiratory diseases affecting clinical trial evaluation.Imaging confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis and other basic pulmonary diseases; 4)Past or present diseases may affect the outcome of the study, such as unresectable malignant tumors, hematological diseases, active bleeding, malignant fluid, liver and kidney diseases, nervous system diseases, endocrine system diseases, etc.; 5)Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ transplantation, etc.; 6)A woman who is pregnant or breastfeeding; 7)Test drug components allergy, or allergic constitution; 8)Patients with a history of substance abuse; 9)Participants in other clinical trials in the last 3 months; 10)The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Recovery time;

Secondary

MeasureTime frame
Disappearance rate of main symptoms(fatigue, dyspnea);COVID-19 RNA negative conversion rate;

Countries

China

Contacts

Public ContactXin Zheng

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Xin11@hotmail.com+86 18602724981

Outcome results

None listed

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