Influenza Clinical Trial
Official title:
Oseltamivir and Arbidol Combination Antiviral Therapy Versus Oseltamivir Monotherapy for the Treatment of Severe influenza: a Multicentre, Double-blind, Randomised Phase 3 Trial
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.
n/a
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