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)

Not Applicable

• Conditions: Novel Coronavirus Pneumonia; 2019-nCoV
• Interventions: Drug: Bromhexine Hydrochloride Tablets; Drug: Arbidol Hydrochloride Granules; Drug: Recombinant Human Interferon α2b Spray

• Registration Number: NCT04273763
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study Start: 2020-02-16
• Study First Posted: 2020-02-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01
• Primary Completion: 2020-05-10
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group A	Bromhexine Hydrochloride Tablets	Treatment group
Group A	Arbidol Hydrochloride Granules	Treatment group
Group A	Recombinant Human Interferon α2b Spray	Treatment group
Group B	Arbidol Hydrochloride Granules	Control group
Group B	Recombinant Human Interferon α2b Spray	Control group

Primary Outcome Measures

Name	Time	Method
Time to clinical recovery after treatment	within 14 days from the start of medication	Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Rate of aggravation	within 14 days from the start of medication	Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg

Secondary Outcome Measures

Name	Time	Method
Clinical remission rate	within 14 days from the start of medication	Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.
Dynamic changes of oxygenation index	within 14 days from the start of medication	oxygenation index
Time to cure	within 14 days from the start of medication	time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
rate to cure	within 14 days from the start of medication	proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence	within 14 days from the start of medication	defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission	within 14 days from the start of medication
Time to dyspnea remission	within 14 days from the start of medication
Days of supplemental oxygenation	within 14 days from the start of medication
Rate of patients with requring supplemental oxygen	within 14 days from the start of medication
Rate of patients with mechanical ventilation	within 14 days from the start of medication
Time of negative COVID-19 nucleic acid results	within 14 days from the start of medication
Rate of negative COVID-19 nucleic acid results	within 14 days from the start of medication
Rate of ICU admission	within 14 days from the start of medication
28-day mortality	From the first day of screening to the day of follow-up (28 days)

Trial Locations

Locations (1)

The Second AffIliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China