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)
University of Oxford
3,000 participants
Feb 22, 2023
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
Inclusion Criteria6
- 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 Criteria16
- 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
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Interventions
Oral oseltamivir 75mg BD for 5/7
Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Inhaled zanamivir 10mg BD for 5/7
Oral baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
Oral molnupiravir 800mg BD for 5/7
Intravenous peramivir 600mg once only
Inhaled laninamivir 40mg once only
Oseltamivir 75mg BD for 5/7 and Baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
Oseltamivir 75mg BD for 5/7 and favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05648448