A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Sponsor
University of Oxford
Study ID
NCT05648448
Phase
PHASE2
Status
Recruiting
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Conditions

  • Influenza
  • Influenza, Human

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Dec 13, 2022
Start date
Feb 22, 2023
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oseltamivir (TAMIFLU®)
  • Experimental: Favipiravir
  • Experimental: Zanamivir (RELENZA®) [Pending addition]
  • Experimental: Baloxavir (XOFLUZA®)
  • Experimental: Molnupiravir [Pending addition]
  • Experimental: Peramivir (RAPIVAB®) [Pending addition]
  • Experimental: Laninamivir (INAVIR®) [Pending addition]
  • Experimental: Oseltamivir and Baloxavir [Pending addition]
  • Experimental: Oseltamivir and Favipiravir [Pending addition]
  • Experimental: Favipiravir and Baloxavir [Pending addition]
  • No Intervention: Negative control group
    No treatment (except antipyretics- paracetamol)

Primary Outcome Measure

Rate of viral clearance for currently available drugs and those with potential activity [ Time Frame: Days 0 - 5 ]

Central Contacts

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