NCT03787459

Severe Influenza Trial of ARbidol

Oseltamivir and Arbidol Combination Antiviral Therapy Versus Oseltamivir Monotherapy for the Treatment of Severe influenza: a Multicentre, Double-blind, Randomised Phase 3 Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Arbidol	Oseltamivir plus Arbidol will be administrated from Days 1-7.
DRUG	Placebos	Oseltamivir plus placebos will be administrated from Days 1-7.

Timeline

• Start date: 2019-01-18
• Primary completion: 2023-04-09
• Completion: 2024-10-17
• First posted: 2018-12-26
• Last updated: 2025-06-25

Locations

1 site across 1 country: China