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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-16

Study Completion Date

2020-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Novel Coronavirus Pneumonia 2019-nCoV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Treatment group

Group Type EXPERIMENTAL

Bromhexine Hydrochloride Tablets

Intervention Type DRUG

Bromhexine Hydrochloride Tablets

Arbidol Hydrochloride Granules

Intervention Type DRUG

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 α2b Spray

Intervention Type DRUG

Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.

Group B

Control group

Group Type ACTIVE_COMPARATOR

Arbidol Hydrochloride Granules

Intervention Type DRUG

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 α2b Spray

Intervention Type DRUG

Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.

Interventions

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Bromhexine Hydrochloride Tablets

Intervention Type DRUG

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.

Intervention Type DRUG

Recombinant Human Interferon α2b Spray

Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No