A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Last updated: October 14, 2024
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

2

Condition

Influenza

Treatment

Drug: Peramivir

Favipiravir

Drug: Zanamivir

Clinical Study ID

NCT05648448
VIR22003
  • Ages 18-60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient understands the procedures and requirements and is willing and able to giveinformed 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, nasalcongestion, rhinorrhoea and sore throat) within 4 days (96 hours)

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

  • Able to walk unaided and unimpeded in activities of daily living (ADLs)

  • Agrees and is able to adhere to all study procedures, including availability andcontact information for follow-up visits

Exclusion

Exclusion Criteria:

The patient may not enter the study if ANY of the following apply:

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

  • Presence of any chronic illness/condition requiring long term treatment or othersignificant comorbidity

  • BMI ≥35 Kg/m2

  • Clinically relevant laboratory abnormalities discovered at screening

  • Haemoglobin <10g/dL

  • Platelet count <100,000/uL

  • ALT > 2x ULN

  • Total bilirubin >1.5 x ULN

  • eGFR <70mls/min/1.73m2

  • For females: pregnancy, actively trying to become pregnant or lactation (healthywomen on OCP are eligible to join)

  • Contraindication to taking, or known hypersensitivity reaction to any of theproposed therapeutics

  • Currently participating in another interventional influenza or COVID-19 therapeutictrial

  • Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations (imaging not required)

  • Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATKor RT-PCR)

  • Received live attenuated influenza virus vaccine within 3 weeks prior to study entry

Study Design

Total Participants: 3000
Treatment Group(s): 17
Primary Treatment: Drug: Peramivir
Phase: 2
Study Start date:
February 22, 2023
Estimated Completion Date:
January 01, 2027

Study Description

Several influenza antivirals are licensed, differing in availability and routes of administration. Direct comparisons of antiviral and clinical efficacy between the multiple available antivirals are lacking. This comparative information is important for guideline development and for aiding purchasing and prioritisation decisions with several options available.

The platform trial will assess the following interventions:

  • Licensed influenza antiviral interventions: oseltamivir (TAMIFLU®), peramivir (RAPIVAB®), zanamivir (RELENZA®), laninamivir (INAVIR®), baloxavir (XOFLUZA®) and favipiravir alone and in combination. The interventions will be chosen in order of priority as well as local feasibility at sites (availability of drugs, local ethics committee and regulatory approvals)

  • Interventions with antiviral activity against influenza demonstrated in pre-clinical studies: molnupiravir

Randomisation to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomisation ratios will be uniform for all available interventions.

Connect with a study center

  • Universidade Federal de Minas Gerais

    Minas Gerais,
    Brazil

    Active - Recruiting

  • Laos-Oxford-Mahosot Wellcome Trust Research unit

    Vientiane,
    Lao People's Democratic Republic

    Active - Recruiting

  • Sukraraj Tropical & Infectious Disease Hospital

    Kathmandu,
    Nepal

    Active - Recruiting

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, 10400
    Thailand

    Active - Recruiting

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