Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
NCT05648448

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Led by University of Oxford · Updated on 2026-04-14

3000

Participants Needed

4

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient understands the procedures and agrees to participate with informed consent
  • Adults aged 18 to 60 years at time of consent
  • Early symptomatic influenza (A or B) with at least one symptom (fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea, sore throat) within 4 days
  • Positive influenza test by rapid antigen or RT-PCR within last 24 hours with Ct value <30
  • Able to walk unaided and perform daily activities
  • Willing and able to follow study procedures and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Taking medications that could interact with study drugs or have antiviral activity
  • Chronic illness requiring long-term treatment or significant comorbidities
  • Body mass index of 35 kg/m2 or higher
  • Abnormal lab results at screening including hemoglobin <10 g/dL, platelet count <100,000/uL, ALT >2 times upper limit, total bilirubin >1.5 times upper limit, or eGFR <70 ml/min/1.73m2
  • Female participants who are pregnant, breastfeeding, or actively trying to conceive (women on oral contraceptives are eligible)
  • Allergy or contraindication to any study drugs
  • Participation in another interventional influenza or COVID-19 therapeutic trial
  • Clinical signs of pneumonia such as shortness of breath, low oxygen levels, or lung crackles
  • Known current co-infection with SARS-CoV-2
  • Received live attenuated influenza vaccine within 3 weeks prior to study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Universidade Federal de Minas Gerais

Minas Gerais, Brazil

Actively Recruiting

2

Laos-Oxford-Mahosot Wellcome Trust Research unit

Vientiane, Laos

Actively Recruiting

3

Sukraraj Tropical & Infectious Disease Hospital

Kathmandu, Nepal

Actively Recruiting

4

Faculty of Tropical Medicine, Mahidol University

Bangkok, Thailand, 10400

Actively Recruiting

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Research Team

W

William Schilling, MD

CONTACT

N

Nicholas J White, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

11

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