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Status unknownNCT04273763Updated May 1, 2020

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)

An interventional study of Bromhexine Hydrochloride Tablets and Arbidol Hydrochloride Granules in Novel Coronavirus Pneumonia and 2019-nCoV, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Novel Coronavirus Pneumonia
  • 2019-nCoV
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 18 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Group A

    Treatment group

    Drug: Bromhexine Hydrochloride Tablets · Drug: Arbidol Hydrochloride Granules · Drug: Recombinant Human Interferon α2b Spray

  • Active comparator
    Group B

    Control group

    Drug: Arbidol Hydrochloride Granules · Drug: Recombinant Human Interferon α2b Spray

Interventions

  • DrugBromhexine Hydrochloride Tablets

    Bromhexine Hydrochloride Tablets

  • DrugArbidol 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.

  • DrugRecombinant Human Interferon α2b Spray

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

06

What researchers measure

Primary outcomes

  1. Time to clinical recovery after treatment

    Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.

    Time frame: within 14 days from the start of medication

  2. 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

    Time frame: within 14 days from the start of medication

Secondary outcomes

  1. 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.

    Time frame: within 14 days from the start of medication

  2. Dynamic changes of oxygenation index

    oxygenation index

    Time frame: within 14 days from the start of medication

  3. Time to cure

    time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery

    Time frame: within 14 days from the start of medication

  4. rate to cure

    proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients

    Time frame: within 14 days from the start of medication

  5. Time to defervescence

    defervescence is defined as below 37 Celcius degrees（ear temperature）

    Time frame: within 14 days from the start of medication

  6. Time to cough remission

    Time frame: within 14 days from the start of medication

  7. Time to dyspnea remission

    Time frame: within 14 days from the start of medication

  8. Days of supplemental oxygenation

    Time frame: within 14 days from the start of medication

  9. Rate of patients with requring supplemental oxygen

    Time frame: within 14 days from the start of medication

  10. Rate of patients with mechanical ventilation

    Time frame: within 14 days from the start of medication

  11. Time of negative COVID-19 nucleic acid results

    Time frame: within 14 days from the start of medication

  12. Rate of negative COVID-19 nucleic acid results

    Time frame: within 14 days from the start of medication

  13. Rate of ICU admission

    Time frame: within 14 days from the start of medication

  14. 28-day mortality

    Time frame: From the first day of screening to the day of follow-up (28 days)

07

Study locations

1 site
  • The Second AffIliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04273763
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
Wanbangde Pharmaceutical Group Co., LTD
Responsible party
Sponsor
First posted
Feb 18, 2020
Start date
Feb 16, 2020
Primary completion
May 10, 2020 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
May 1, 2020

Study contacts

XIAN SHEN, phd
study chair · The 2nd Affiliated Hospital of Wenzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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