Last updated 4 months ago
A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
3000 patients around the world
Available in Brazil
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.
University of Oxford
1Research sites
3000Patients around the world
This study is for people with
Influenza
Influenza a
Influenza b
Requirements for the patient
To 60 Years
All Gender
Medical requirements
- 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.Able to walk unaided and unimpeded in activities of daily living (ADLs).Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits.
- 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.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 (healthy women on OCP are eligible to join).Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics.Currently participating in another interventional influenza or COVID-19 therapeutic trial.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 ATK or RT-PCR).Received live attenuated influenza virus vaccine within 3 weeks prior to study entry.
Sites
Universidade Federal de Minas Gerais
Recruiting
StudyAD ASTRA
SponsorUniversity of Oxford
Study typeInterventional
Conditions
Influenza aInfluenza b
Requirements
To 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05648448
