Health Trials

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

ConditionsInfluenzaInfluenza, Human
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Oxford

About this trial

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

Eligibility criteria

Qualifiers

Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study

Adults, male or female, aged 18 to 60 years at time of consent.

Early symptomatic Influenza (A or B); at least one reported symptom of influenza (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)

Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza viruses within the last 24hrs with a Ct value of <30

Disqualifiers

Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity

Presence of any chronic illness/condition requiring long term treatment or other significant comorbidity

BMI ≥35 Kg/m2

Clinically relevant laboratory abnormalities discovered at screening

Trial design

Treatments tested in this trial

  • Oseltamivir
  • Favipiravir
  • Zanamivir
  • Baloxavir
  • Molnupiravir
  • Peramivir
  • Laninamivir
  • Oseltamivir and Baloxavir
  • Oseltamivir and Favipiravir
  • Favipiravir and Baloxavir

Treatment groups

3,000 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Oxford

Lead sponsor

Source ClinicalTrials.gov