Influenza
Conditions
Interventions
Experimental group:Arbidol hydrochloride tablets, 200MG, three times a day, for 5 days.
Control Group:Oseltamivir phosphate capsules, 75 mg, twice daily for 5 days.
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) signed informed consent; 2) age =12 years, regardless of gender; 3) subjects with influenza virus infection who tested positive for influenza rapid antigen or nucleic acid in nasal/pharyngeal swabs were tested for influenza rapid antigen first, and the results of influenza rapid nucleic acid test were accepted when the center could not be tested for influenza rapid antigen; 4) body temperature (axillary temperature) remained =38.0 ° C during pre-medication testing (screening period) or 4 hours after antipyretic treatment; 5) a general symptom or respiratory symptom with moderate/2 or severe/3 severity (referred to the ISS symptom scale-RRB- occurred within 72 hours, and the symptoms did not exceed 72 hours: a general symptoms were headache, chills or fever, muscle or joint pain, fatigBe; b respiratory symptoms were cough, sore throat, and nasal congestion.
Exclusion criteria
Exclusion criteria: 1) history of drug allergy and/or severe allergic constitution, 2) history of severe heart disease or clinically significant arrhythmias (based on ECG or medical history) that the investigators believe will affect the safety of the subject, 3) abnormal laboratory findings, a) hematologic dysfunction defined as: I) white blood cell (WBC) count: 1.5 times the ULN, or calculated creatinine clearance < 50 ml/min;4) The presence of pneumonia secondary to bacterial pneumonia or other pathogens. 5) With the following current medical history: a )Chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, etc.) b) Neurological and neurodevelopmental disorders, including brain, spinal cord, peripheral nerve and muscle diseases (e.g. cerebral palsy, epilepsy, stroke, mental retardation, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) ; c) Cardiovascular disease (congenital heart defect, heart failure or coronary artery disease) , excluding hypertension without heart-related symptoms. d) Impaired immune systems (including those on immunosuppressive therapy, those on long-term steroid hormone or for longer than 5 days) ;6) received other antiviral drug treatment (including Peramivir, Zanamivir, amantidine, ganmaoling granule, Lianhua Qingwen capsule)2 days before or during the screening period;7) patients with severe influenza: a) persistent high fever for more than 3 days, accompanied by severe cough, purulent sputum, bloody sputum, or chest pain; b) rapid breathing, dyspnea, cyanosis of the lips; c) changes in consciousness: unresponsive, lethargic, restlessness, convulsion, etc. ; d) severe vomiting, diarrhea, dehydration, e) complicated with pneumonia; f) the original underlying disease significantly aggravated; g) other clinical conditions requiring hospitalization8) patients in critical condition a) had respiratory failure; B) acute necrotizing encephalopathy; c) septic shock; D) multiple organ dysfunction syndrome; E) other severe clinical conditions requiring intensive care; 9) serum pregnancy test was positive in women of reproductive age; 10) women were lactating; and 11) were considered unsuitable for enrollment by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of relief of flu symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antipyretic time;30-day hospitalization rate;Percentage of subjects with influenza complications;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactRongmeng Jiang
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed