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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04273763
Other study ID # 2019NCP1.0
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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