A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Recruiting now · Phase 2

Conditions studied: Influenza, Influenza, Human

In brief

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

Key facts

Study ID

NCT05648448

Run by

University of Oxford

People needed

3000

Starts

2023-02-22

Expected to finish

2027-01-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Universidade Federal de Minas Gerais — Minas Gerais, Brazil (enrolling)
• Laos-Oxford-Mahosot Wellcome Trust Research unit — Vientiane, Laos (enrolling)
• Sukraraj Tropical & Infectious Disease Hospital — Kathmandu, Nepal (enrolling)
• Faculty of Tropical Medicine, Mahidol University — Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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