influenza
Conditions
Interventions
Lianhua Qingwen capsule group:Lianhua Qingwen capsules, 4 capsules/time, 3 times a day
Lianhua Qingwen capsule simulant group:Lianhua Qingwen capsule simulant, 4 capsules / time, 3 times a day
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for index cases: (1) Gender and age are not limited; (2) At least two of the following flu-like symptoms appear: Fever, cough, nasal congestion, sore throat, headache, runny nose and muscle or joint pain, and the symptom score is =1; (3) The flu-like symptoms first occur within 48 hours; (4) Patients who are rapidly tested positive for influenza and meet the clinical diagnosis criteria of influenza; (5) In addition to the index cases, there are 2 or more adult close contacts who meet the inclusion criteria and do not meet the exclusion criteria in the clustered units (i.e. the co-living environments, including the same families, school dormitories, factory dormitories and shared units, etc.); (6) Volunteers who are willing to participate in this study and sign a written ICF. Inclusion criteria for clustered close contacts: (1) The index cases in the same clustered units who meet the inclusion criteria and does not meet the exclusion criteria; (2) 18 = age = 70; (3) The result of rapid influenza virus antigen test is negative; (4) No flu-like symptoms occur within 1 week before randomization (the total score of flu-like symptoms is 0); (5) During 9 days after randomization, persons who are expected to live with the index cases for at least 7 days and be able to participate in visits as planned; (6) Volunteers who are willing to participate in this study and sign a written ICF.
Exclusion criteria
Exclusion criteria: Exclusion criteria for index cases: (1) The result of COVID-19 antigen test is positive; (2) The close contacts in the clustered units who participated in this study but are tested positive for COVID-19; (3) Severe and critical patients who require hospitalization; (4) Patients with other serious clinical conditions who require hospitalization or monitoring; (5) Other patients considered by the investigator to be inappropriate to participate in this study. Exclusion criteria for clustered close contacts: (1) The result of rapid COVID-19 antigen test is positive; (2) Pregnant perinatal and nursing women; (3) Patients combined with serious diseases of major organs or systems such as heart, brain, respiratory system, circulatory system, endocrine system, immune system, and hematopoietic system (such as congestive cardiac failure, with severity levels of III to IV by NYHA classification; significant arrhythmias or abnormal heart valves that cause hemodynamic impairment; history of unstable angina or myocardial infarction within the past 6 months; malignant tumors in the non-radiotherapy or non-chemotherapy stable period; advanced stage of pulmonary tuberculosis; severe hypertension; diabetic complications such as diabetic ketoacidosis; immunodeficiency diseases such as HIV that have not achieved immune function reconstruction; autoimmune diseases such as systemic lupus erythematosus); (4) ALT > 5 ULN, AST > 5 ULN or SCr >1.5 ULN in the screening results; (5) Persons who have taken Lianhua Qingwen preparation or any drugs with antiviral effect within 7 days. (Such as: Jinhua Qinggan, Qingkailing, Shufengjiedu, Yinqiaojiedu, Sangjuganmao, Banlangen, Yinhuang, oseltamivir, zanamivir and peramivir in any dosage form); (6) Persons who have been vaccinated against influenza within 6 months; (7) Persons who are allergic to the investigational drug; (8) Patients who have participated in other drug clinical trials within 1 month prior to the screening test; (9) Other patients considered by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The secondary infection risk (SIR) of influenza to the close contacts taking Lianhua Qingwen capsules or the placebo within 9 days (±1 day) after randomization, i.e. the proportion of close contacts of secondary transmission of influenza including symptomatic and asymptomatic cases.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportions of infected clustered units in all clustered units on Days 3, 5 and 9 (±1) after randomization.;The proportions of all the closed contacts with positive PCR test results (sum of symptomatic and asymptomatic cases) on Days 3, 5, and 9 (±1) after randomization;; The proportions of all the closed contacts with positive PCR test results (symptomatic cases) on Days 3, 5, and 9 (±1) after randomization. ;Comparison of the mean scores of influenza-like symptoms that first occur to secondary transmission cases.;The proportion of secondary transmission cases who require taking other drugs for influenza.; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed