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)

2019-nCoV Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04273763
• Other study ID #: 2019NCP1.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 16, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 1, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• 2019-nCoV
• Coronavirus Infections
• Novel Coronavirus Pneumonia
• Pneumonia

Intervention

Drug:
• Bromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets
• Arbidol Hydrochloride Granules
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection. Arbidol Hydrochloride Granules is recommended but not enforced to use.
• Recombinant Human Interferon a2b Spray
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.

Locations

Country	Name	City	State
China	The Second AffIliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University	WanBangDe Pharmaceutical Group Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical recovery after treatment	Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.	within 14 days from the start of medication
Primary	Rate of aggravation	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	within 14 days from the start of medication
Secondary	Clinical remission rate	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.	within 14 days from the start of medication
Secondary	Dynamic changes of oxygenation index	oxygenation index	within 14 days from the start of medication
Secondary	Time to cure	time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery	within 14 days from the start of medication
Secondary	rate to cure	proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients	within 14 days from the start of medication
Secondary	Time to defervescence	defervescence is defined as below 37 Celcius degrees(ear temperature)	within 14 days from the start of medication
Secondary	Time to cough remission		within 14 days from the start of medication
Secondary	Time to dyspnea remission		within 14 days from the start of medication
Secondary	Days of supplemental oxygenation		within 14 days from the start of medication
Secondary	Rate of patients with requring supplemental oxygen		within 14 days from the start of medication
Secondary	Rate of patients with mechanical ventilation		within 14 days from the start of medication
Secondary	Time of negative COVID-19 nucleic acid results		within 14 days from the start of medication
Secondary	Rate of negative COVID-19 nucleic acid results		within 14 days from the start of medication
Secondary	Rate of ICU admission		within 14 days from the start of medication
Secondary	28-day mortality		From the first day of screening to the day of follow-up (28 days)