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A randomized, parallel controlled trial for the efficacy and safety of Sodium Aescinate Injection in the treatment of patients with pneumonia (COVID-19)

A randomized, parallel controlled trial for the efficacy and safety of Sodium Aescinate Injection in the treatment of patients with pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029742
Enrollment
Unknown
Registered
2020-02-11
Start date
2020-02-10
Completion date
Unknown
Last updated
2020-02-17

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

General patients treated with normal treatment:Normal Treatment
General patients experimental group:Normal Treatment plus Sodium Aescinate for Injection
Severe patients control group 1:Normal treatment plus hormonotherapy
Severe patients control group 2:Normal Treatment
Severe patients experimental group:Normal Treatment plus Sodium Aescinate for Injection

Sponsors

Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 to 70 years; 2. Diagnosed 2019-nCoV infected patients by viral nucleic acid,or although the test was negative and even not be detected, the reseachers judged it to be a novel coronavirus pneumonia; 3. Understand and agree to participate in this study and sign informed consent; 4. According to the guideline of clinical classification of novel coronavirus pneumonia (2019-nCoV) diagnosis and treatment plan (trial version fifth), the general patients were included in the selection criteria: fever, respiratory tract symptoms, imaging findings of pneumonia; Severe patients were selected according to the following criteria: 1) respiratory distress, RR >= 30 times / minute; 2) resting state, mean oxygen saturation less than 93%; 3) artery. PaO2 / FiO2 <= 300MMHG (1mmhg = 0.133kpa).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or pregnant; 2. Those who are allergic to the drug ingredients of this program; 3. Severe cardiovascular diseases, such as severe center of gravity dysfunction, second or third degree atrioventricular block, etc.; 4. Severe hepatic insufficiency: defined as the upper limit of ALT > 2 times normal value or AST > 2 times normal value; 5. Severe renal insufficiency: defined as creatinine > 1.5 times the upper limit of normal value; 6. Have asthma, COPD serious respiratory disease; 7. Serious blood diseases, such as coagulation disorders, systemic bleeding, platelet diseases, etc; 8. Serious endocrine system diseases, such as type II diabetes; 9. Patients with malignant tumor; 10. Patients taking antiedematous drugs for a long time; 11. Major operation history; 12. Other clinical researchers.

Design outcomes

Primary

MeasureTime frame
Chest imaging (CT);

Secondary

MeasureTime frame
Safty;Blood biochemistry index;viral nucleic acid fo 2019-nCoV;

Countries

China

Contacts

Public ContactQin Ning, Meifang Han

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

31531955@qq.com+86 27 83662688

Outcome results

None listed

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