NCT05648448

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

Several influenza antivirals are licensed, differing in availability and routes of administration. Direct comparisons of antiviral and clinical efficacy between the multiple available antivirals are lacking. This comparative information is important for guideline development and for aiding purchasing and prioritisation decisions with several options available. The platform trial will assess the following interventions: * Licensed influenza antiviral interventions: oseltamivir (TAMIFLU®), peramivir (RAPIVAB®), zanamivir (RELENZA®), laninamivir (INAVIR®), baloxavir (XOFLUZA®) and favipiravir alone and in combination. The interventions will be chosen in order of priority as well as local feasibility at sites (availability of drugs, local ethics committee and regulatory approvals) * Interventions with antiviral activity against influenza demonstrated in pre-clinical studies: molnupiravir Randomisation to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomisation ratios will be uniform for all available interventions.

Conditions

• Influenza
• Influenza, Human

Interventions

Type	Name	Description
DRUG	Oseltamivir	Oral oseltamivir 75mg BD for 5/7
DRUG	Favipiravir	Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
DRUG	Zanamivir	Inhaled zanamivir 10mg BD for 5/7
DRUG	Baloxavir	Oral baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
DRUG	Molnupiravir	Oral molnupiravir 800mg BD for 5/7
DRUG	Peramivir	Intravenous peramivir 600mg once only
DRUG	Laninamivir	Inhaled laninamivir 40mg once only
DRUG	Oseltamivir and Baloxavir	Oseltamivir 75mg BD for 5/7 and Baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
DRUG	Oseltamivir and Favipiravir	Oseltamivir 75mg BD for 5/7 and favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
DRUG	Favipiravir and Baloxavir	favipiravir 1800mg BD D0 and 800mg BD for a further 4/7 Baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0

Timeline

• Start date: 2023-02-22
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-12-13
• Last updated: 2026-04-14

Locations

4 sites across 4 countries: Brazil, Laos, Nepal, Thailand