A multicenter, randomized, open and controlled trial for the efficacy and safety of Kang-Bing-Du granules in the treatment of novel coronavirus pneumonia (COVID-19)

Phase 4

Recruiting

• Conditions: ovel Coronavirus Pneumonia (COVID-19)

• Registration Number: ITMCTR2000003005
• Lead Sponsor: nion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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 I ~ II;
4) Hospitalized for:
Fever: axillary temperature >= 36.7 degree C, oral temperature >= 38.0 degree C, Anal temperature >= 38.6 degree C;
respiratory rate > 24 times / min or cough (at least one of them);
5) The course of symptoms should be less than or equal to 8 days;
6) Volunteers and comply with the hospital regulations, can cooperate with the completion of the prescribed inspection;
7) Voluntary informed consent was signed prior to the trial.

Exclusion Criteria

1)One of the following conditions:
Respiratory distress, RR >= 30 times/min;
At rest, oxygen saturation is less than 93%;
Atrial 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.
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)It is expected to be transferred to a non-study hospital within 72 hours;
5)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 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disappearance rate of fever symptoms;