Comparing antiviral treatments for 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)
This study is testing different antiviral medications to see which ones work best for people with early symptoms of the flu who are otherwise healthy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 4 sites (Minas Gerais and 3 other locations) |
| Trial ID | NCT05648448 on ClinicalTrials.gov |
What this trial studies
This trial aims to quantitatively assess the antiviral effects of various licensed and investigational antiviral treatments in low-risk patients with uncomplicated influenza. It employs a randomised, open-label, controlled, group sequential, adaptive platform design to compare the efficacy of antiviral medications such as oseltamivir, zanamivir, and molnupiravir against a control group receiving no treatment. The study will focus on patients who present with early symptoms of influenza and have confirmed viral infections. The goal is to provide comparative data that can inform treatment guidelines and decision-making for antiviral therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 years who have early symptomatic influenza and are able to provide informed consent.
Not a fit: Patients with severe influenza symptoms or those taking medications that could interact with the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with influenza, improving recovery times and outcomes.
How similar studies have performed: Other studies have shown success in evaluating antiviral treatments for influenza, but this platform approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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 this trial is running
Minas Gerais and 3 other locations
- Universidade Federal de Minas Gerais — Minas Gerais, Brazil (Recruiting)
- Laos-Oxford-Mahosot Wellcome Trust Research unit — Vientiane, Laos (Recruiting)
- Sukraraj Tropical & Infectious Disease Hospital — Kathmandu, Nepal (Recruiting)
- Faculty of Tropical Medicine, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: William Schilling, MD
- Email: william@tropmedres.ac
- Phone: +662 203 6333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.