Clinical trial NCT04273763: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Novel Coronavirus Pneumonia
2019-nCoV
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wanbangde Pharmaceutical Group Co., LTD
First posted: 2020-02-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 (COVID-19).

Random, open, group sequential design.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 80 years (Including 18and 80years, male or female).
* One of them:

  1. Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus pneumonia (COVID-19).
  2. Patients diagnosed clinically as suspected cases.
* Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to clinical recovery after treatment
timeFrame: within 14 days from the start of medication
measure: Rate of aggravation
timeFrame: within 14 days from the start of medication
Secondary outcomes:
measure: Clinical remission rate
timeFrame: within 14 days from the start of medication
measure: Dynamic changes of oxygenation index
timeFrame: within 14 days from the start of medication
measure: Time to cure
timeFrame: within 14 days from the start of medication
measure: rate to cure
timeFrame: within 14 days from the start of medication
measure: Time to defervescence
timeFrame: within 14 days from the start of medication
measure: Time to cough remission
timeFrame: within 14 days from the start of medication
measure: Time to dyspnea remission
timeFrame: within 14 days from the start of medication
measure: Days of supplemental oxygenation
timeFrame: within 14 days from the start of medication
measure: Rate of patients with requring supplemental oxygen
timeFrame: within 14 days from the start of medication
measure: Rate of patients with mechanical ventilation
timeFrame: within 14 days from the start of medication
measure: Time of negative COVID-19 nucleic acid results
timeFrame: within 14 days from the start of medication
measure: Rate of negative COVID-19 nucleic acid results
timeFrame: within 14 days from the start of medication
measure: Rate of ICU admission
timeFrame: within 14 days from the start of medication
measure: 28-day mortality
timeFrame: From the first day of screening to the day of follow-up (28 days)
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second AffIliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The 2nd Affiliated Hospital of Wenzhou Medical University
name: XIAN SHEN, phd
role: STUDY_CHAIR
References: