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A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
Sponsor: University of Oxford
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
Conditions
Interventions
Oseltamivir
Oral oseltamivir 75mg BD for 5/7
Favipiravir
Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Zanamivir
Inhaled zanamivir 10mg BD for 5/7
Baloxavir
Oral baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
Molnupiravir
Oral molnupiravir 800mg BD for 5/7
Peramivir
Intravenous peramivir 600mg once only
Laninamivir
Inhaled laninamivir 40mg once only
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
Oseltamivir and Favipiravir
Oseltamivir 75mg BD for 5/7 and favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
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