Novel Coronavirus PneumoniaNCT04273763
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)
A study testing Bromhexine Hydrochloride Tablets, Arbidol Hydrochloride Granules and Recombinant Human Interferon α2b Spray in people with Novel Coronavirus Pneumonia and 2019-nCoV, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Novel Coronavirus Pneumonia, 2019-nCoV
- What is being tested?
- Bromhexine Hydrochloride Tablets, Arbidol Hydrochloride Granules and Recombinant Human Interferon α2b Spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years (Including 18and 80years, male or female).
- One of them:
- Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus pneumonia (COVID-19).
- Patients diagnosed clinically as suspected cases.
- Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second AffIliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
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.
- Conditions
- Novel Coronavirus Pneumonia, 2019-nCoV
- Being tested
- Bromhexine Hydrochloride Tablets, Arbidol Hydrochloride Granules, Recombinant Human Interferon α2b Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromhexine Hydrochloride TabletsDrug
Bromhexine Hydrochloride Tablets
Arbidol Hydrochloride GranulesDrug
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 SprayDrug
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment group Receives: Drug: Bromhexine Hydrochloride Tablets; Drug: Arbidol Hydrochloride Granules; Drug: Recombinant Human Interferon α2b Spray |
| Group B | Active comparator | Control group Receives: Drug: Arbidol Hydrochloride Granules; Drug: Recombinant Human Interferon α2b Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery after treatment
Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Measured: within 14 days from the start of medication
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
Measured: within 14 days from the start of medication
Secondary outcomes (14)
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.
Measured: within 14 days from the start of medication
Dynamic changes of oxygenation index
oxygenation index
Measured: within 14 days from the start of medication
Time to cure
time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
Measured: within 14 days from the start of medication
rate to cure
proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Measured: within 14 days from the start of medication
Time to defervescence
defervescence is defined as below 37 Celcius degrees（ear temperature）
Measured: within 14 days from the start of medication
Time to cough remission
Measured: within 14 days from the start of medication
Time to dyspnea remission
Measured: within 14 days from the start of medication
Days of supplemental oxygenation
Measured: within 14 days from the start of medication
Rate of patients with requring supplemental oxygen
Measured: within 14 days from the start of medication
Rate of patients with mechanical ventilation
Measured: within 14 days from the start of medication
Time of negative COVID-19 nucleic acid results
Measured: within 14 days from the start of medication
Rate of negative COVID-19 nucleic acid results
Measured: within 14 days from the start of medication
Rate of ICU admission
Measured: within 14 days from the start of medication
28-day mortality
Measured: From the first day of screening to the day of follow-up (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start16 Feb 2020
- Primary completion10 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel Coronavirus PneumoniaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wanbangde Pharmaceutical Group Co., LTD
- Responsible party
- Sponsor
- Investigators
- XIAN SHEN, phd, Study chair, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273763
- Sponsor's protocol ID
- 2019NCP1.0
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2020
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04273763
- Acronym / sponsor ID
- 2019NCP1.0
- Conditions
- Novel Coronavirus Pneumonia, 2019-nCoV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Wanbangde Pharmaceutical Group Co., LTD
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 10 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Bromhexine Hydrochloride Tablets, Drug: Arbidol Hydrochloride Granules, Drug: Recombinant Human Interferon α2b SprayTreatment group |
| Group B | Active comparator | Drug: Arbidol Hydrochloride Granules, Drug: Recombinant Human Interferon α2b SprayControl group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 80 years (Including 18and 80years, male or female).
- One of them:
- Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromhexine Hydrochloride TabletsBromhexine Hydrochloride Tablets | Drug | Group A |
| Arbidol Hydrochloride GranulesStandard 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. | Drug | Group A, Group B |
| Recombinant Human Interferon α2b SprayStandard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection. | Drug | Group A, Group B |
Primary outcome
Time to clinical recovery after treatment
Time frame: 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
Time frame: 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
14 secondary outcomes
Clinical remission rate
Time frame: within 14 days from the start of medication
Dynamic changes of oxygenation index
Time frame: within 14 days from the start of medication
Time to cure
Time frame: within 14 days from the start of medication
rate to cure
Time frame: within 14 days from the start of medication
Time to defervescence
Time frame: within 14 days from the start of medication
Time to cough remission
Time frame: within 14 days from the start of medication
Time to dyspnea remission
Time frame: within 14 days from the start of medication
Days of supplemental oxygenation
Time frame: within 14 days from the start of medication
Rate of patients with requring supplemental oxygen
Time frame: within 14 days from the start of medication
Rate of patients with mechanical ventilation
Time frame: within 14 days from the start of medication
Time of negative COVID-19 nucleic acid results
Time frame: within 14 days from the start of medication
Rate of negative COVID-19 nucleic acid results
Time frame: within 14 days from the start of medication
Rate of ICU admission
Time frame: within 14 days from the start of medication
28-day mortality
Time frame: From the first day of screening to the day of follow-up (28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XIAN SHEN, phd study chair
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromhexine Hydrochloride Tablets, Arbidol Hydrochloride Granules and Recombinant Human Interferon α2b Spray in people with Novel Coronavirus Pneumonia and 2019-nCoV, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical recovery after treatment (time frame: within 14 days from the start of medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.