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A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Study acronym: AD ASTRA
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. 3 versions Re-verified since Jan 8, 2026, no change to tracked fieldsv9-v11
  2. Study sites: 1 to 4
    • Eligibility criteria revised
    v8
  3. Enrollment target: 250 to 3000v7 Show 6 more changesShow less
    • Primary completion date: Dec 1, 2024 to Jan 1, 2027
    • Study completion date: Jan 1, 2025 to Jan 1, 2027
    • Interventions: Drug: Baloxavir (Drug), Drug: Favipiravir (Drug), Drug: Laninamivir (Drug), Drug: Molnupiravir (Drug), Drug: Oseltamivir (Drug), Drug… to Baloxavir (Drug), Favipiravir (Drug), Favipiravir and Baloxavir (Drug), Laninamivir (Drug), Molnupiravir (Drug), Oseltamivir (Drug)…
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study arms: 8 to 11
    • Study description expanded, about 4 words
  4. 2 versions Re-verified since May 2, 2023, no change to tracked fieldsv5-v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 22, 2023 to Feb 22, 2023
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria expanded, about 15 words
    • Study title shortened, about 7 words
    v3
  2. Start date: Dec 22, 2022 to Jan 22, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05648448
Lead Sponsor University of Oxford
Conditions
(from sponsor)		 Influenza, Influenza, Human
Related terms Influenza, Human
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov