This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200 hospitalized adults and adolescent patients with confirmed severe influenza. Patients should be randomised as soon as possible after screening (no later than 12 hours), providing they are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to meet the inclusion and exclusion criteria will be permitted only once, providing the time from symptom onset to randomization is still within 7 days. Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment). Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the corresponding placebo for arbidol, will be started at the time of randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Oseltamivir plus Arbidol will be administrated from Days 1-7.
Oseltamivir plus placebos will be administrated from Days 1-7.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days
the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged
Time frame: 28 days
Time to decline of one category on the seven-category ordinal scale of clinical status lasting for 48h, or hospital discharge within 28 days, days
the event defined as seven-category ordinal scale of clinical status after enrolment decrease by one category or discharged
Time frame: Up to 28 days
Day 28 mortality rate
Time frame: 28 days
Proportion of Clinical Improvement (≥2-category decline / discharge with improvement) at Days 7, 14, and 28 since arbidol initiation
Time frame: Up to 28 days
Proportion of Patients at Each Category of the 7-category Ordinal Scale at Days 7, 14, and 28
Time frame: up to 28 days
Duration of Mechanical Ventilation (days), Oxygen Therapy (days), Hospitalization (days), Time from Randomization to Discharge (days), Time from Randomization to Death (days)
Time frame: Up to 28 days
Incidence of Secondary Infection, Secondary Aspergillus and Bacterial Infection
Time frame: Up to 28 days
Patients Requiring Continuous Renal Replacement Therapy (CRRT) After Treatment
Time frame: Up to 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.