RecruitingPhase 2NCT05648448

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)


Sponsor

University of Oxford

Enrollment

3,000 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study compares different antiviral medicines to find the best treatment for influenza (the flu) when started early in the illness. Participants must have flu symptoms that started within the last 4 days and a positive flu test. The goal is to see which treatment works fastest and most effectively. You may be eligible if: - You are 18–60 years old - You have been diagnosed with influenza A or B by a rapid test or PCR within the last 24 hours - Your flu symptoms started within the last 4 days (96 hours) - You can walk and carry out daily activities on your own You may NOT be eligible if: - You are taking other medications that interact with antiviral drugs - You have a chronic illness requiring long-term treatment - Your BMI is 35 or above - You are pregnant, trying to become pregnant, or breastfeeding - You have signs of pneumonia (shortness of breath, low oxygen levels) - You also have a current COVID-19 infection - You received a live influenza vaccine in the past 3 weeks - You have significant blood, liver, or kidney abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOseltamivir

Oral oseltamivir 75mg BD for 5/7

DRUGFavipiravir

Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7

DRUGZanamivir

Inhaled zanamivir 10mg BD for 5/7

DRUGBaloxavir

Oral baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0

DRUGMolnupiravir

Oral molnupiravir 800mg BD for 5/7

DRUGPeramivir

Intravenous peramivir 600mg once only

DRUGLaninamivir

Inhaled laninamivir 40mg once only

DRUGOseltamivir and Baloxavir

Oseltamivir 75mg BD for 5/7 and Baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0

DRUGOseltamivir and Favipiravir

Oseltamivir 75mg BD for 5/7 and favipiravir 1800mg BD D0 and 800mg BD for a further 4/7

DRUGFavipiravir and Baloxavir

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


Locations(4)

Universidade Federal de Minas Gerais

Minas Gerais, Brazil

Laos-Oxford-Mahosot Wellcome Trust Research unit

Vientiane, Laos

Sukraraj Tropical & Infectious Disease Hospital

Kathmandu, Nepal

Faculty of Tropical Medicine, Mahidol University

Bangkok, Thailand

View Full Details on ClinicalTrials.gov

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NCT05648448


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