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A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

NCT05648448 ↗

Phase 2 Recruiting 3000 enrolled University of Oxford
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other. AD ASTRA study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator

Timeline

Start
2023-02-22
Primary completion
2027-01-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Baloxavir Unknown 40 mg Oral
Subject Baloxavir Unknown 80 mg Oral
Subject Favipiravir Small molecule 800 mg Oral
Subject Laninamivir Small molecule 40 mg Inhaled
Subject Molnupiravir Small molecule 800 mg Oral
Subject Oseltamivir Small molecule 75 mg Oral
Subject PERAMIVIR ANHYDROUS Small molecule 600 mg Intravenous
Subject Zanamivir Small molecule 10 mg Inhaled

Indications

influenza