Status:
UNKNOWN
Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Wanbangde Pharmaceutical Group Co., LTD
Conditions:
Novel Coronavirus Pneumonia
2019-nCoV
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COV...
Eligibility Criteria
Inclusion
- Aged between 18 and 80 years (Including 18and 80years, male or female).
- One of them:
- Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus pneumonia (COVID-19).
- Patients diagnosed clinically as suspected cases.
- Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.
Exclusion
- ALT≥5 times of ULN, level of total bilirubin≥3 times of ULN, or Cr≥1.5 times of ULN.
- Patients with serious severe liver disease.
- Excluded who diagnosed as pneumonia patients with novel coronavirus infection of severe type and critical type. 【Diagnostic criteria reference the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5) "】.
- Patients with previous history of severe gastrointestinal diseases such as gastric ulcers and bleeding.
- Patients with lactose intolerance.
- Patients who are allergic to the components of this medicine (Major components: Bromhexine Hydrochloride; excipient: starch, lactose, magnesium stearate).
- Positive serum pregnancy test result for women with childbearing potential at screening or lactating women.
- Other circumstances that the researcher considers inappropriate to participate in this study.
Key Trial Info
Start Date :
February 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04273763
Start Date
February 16 2020
End Date
June 1 2020
Last Update
May 1 2020
Active Locations (1)
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1
The Second AffIliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000