Actively Recruiting
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)
Led by University of Oxford · Updated on 2026-04-14
3000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the antiviral effects of various treatments in adults aged 18 to 60 with early symptomatic influenza. This phase 2, multi-centre, adaptive platform trial compares several licensed influenza antiviral drugs and others with potential activity against the virus. The study aims to provide clear comparisons of antiviral activity to help guide treatment decisions and policy development. Participants may receive one of several antiviral drugs such as oseltamivir, favipiravir, zanamivir, baloxavir, molnupiravir, peramivir, laninamivir, or combinations of these medications. There is also a control group that receives no antiviral treatment except paracetamol for fever. Dosages and administration routes vary by drug and include oral, inhaled, and intravenous methods. The trial uses randomization to assign treatments, with at least 20% of participants assigned to the no treatment group. During the first five days, researchers will monitor the rate of viral clearance to assess antiviral activity. Additional measures include symptom relief and fever duration over 14 days. Participants will be closely followed up, with assessments including rapid antigen or PCR tests for influenza, symptom tracking, and safety monitoring. The total study period covers initial treatment and observation up to two weeks after starting treatment.
CONDITIONS
Brief Title
A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
Who Can Participate
Eligibility Criteria
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 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
You will not qualify if you...
- Taking medications that may interact with study drugs or have antiviral activity
- Presence of chronic illness or significant comorbidity requiring long-term treatment
- Body mass index 35 kg/m2 or higher
- Abnormal lab results at screening including low hemoglobin, low platelets, elevated liver enzymes, elevated bilirubin, or reduced kidney function
- For females: pregnancy, lactation, or actively trying to become pregnant (except healthy women on oral contraceptives)
- Allergy or contraindication to study drugs
- Participation in another interventional influenza or COVID-19 trial
- Clinical signs of pneumonia such as shortness of breath or hypoxia
- Known co-infection with SARS-CoV-2
- Received live attenuated influenza vaccine within 3 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive assigned antiviral treatments or no antiviral treatment to assess antiviral pharmacodynamics in early symptomatic influenza.
Daily visits or assessments during the 5-day treatment period
Duration - Up to 14 days after treatment begins
Participants are monitored for symptom alleviation and fever duration after treatment ends.
Follow-up visits as needed up to Day 14
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
Research Team
W
William Schilling, MD
N
Nicholas J White, Prof
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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