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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Bromhexine Hydrochloride Tablets
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.
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.
The Second AffIliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
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
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
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
Dynamic changes of oxygenation index
oxygenation index
Time frame: within 14 days from the start of medication
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
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
Time to defervescence
defervescence is defined as below 37 Celcius degrees(ear temperature)
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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)