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RECRUITING
NCT05648448
PHASE2

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Sponsor: University of Oxford

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2023-02-22

Completion Date

2027-01-01

Last Updated

2026-02-19

Healthy Volunteers

No

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

Locations (4)

Universidade Federal de Minas Gerais

Minas Gerais, Brazil

Laos-Oxford-Mahosot Wellcome Trust Research unit

Vientiane, Laos

Sukraraj Tropical & Infectious Disease Hospital

Kathmandu, Nepal

Faculty of Tropical Medicine, Mahidol University

Bangkok, Thailand