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Severe Influenza Trial of ARbidol

NCT03787459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

DRUG

Arbidol

Oseltamivir plus Arbidol will be administrated from Days 1-7.

DRUG

Placebos

Oseltamivir plus placebos will be administrated from Days 1-7.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Peking University

    collaborator OTHER

  • National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Capital Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2023-04-09
Completion
2024-10-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787459 on ClinicalTrials.gov