A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

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

Conditions

• Influenza
• Influenza, Human

Interventions

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

Sponsors & Collaborators

• University of Oxford

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-22

Primary Completion

2027-01-01

Completion

2027-01-01

Countries

• Brazil
• Laos
• Nepal
• Thailand

Study Locations