A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
AD ASTRA
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)
1 other identifier
interventional
3,000
4 countries
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 14, 2026
February 1, 2026
3.9 years
December 5, 2022
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of viral clearance for currently available drugs and those with potential activity
Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/saliva taken daily from baseline (day 0) to day 7 for each therapeutic arm compared with the no antiviral treatment control i.e. those not receiving study drug
Days 0 - 5
Secondary Outcomes (3)
Rate of viral clearance in early influenza infection
Days 0 - 5
Rate of viral clearance for drugs shown to have considerable antiviral activity
Days 0 - 5
Time to symptom alleviation and fever duration
Days 0 - 14
Other Outcomes (3)
Rates of hospitalisation for clinical trial reasons
Days 0 - 28
Development of influenza-related complications
Days 0 - 28
7. Relationship between viral clearance, randomisation arm and other measures (covariates) and development of symptoms or functional issues following illness with influenza.
Days 0-120
Study Arms (11)
Oseltamivir (TAMIFLU®)
EXPERIMENTALFavipiravir
EXPERIMENTALZanamivir (RELENZA®) [Pending addition]
EXPERIMENTALBaloxavir (XOFLUZA®)
EXPERIMENTALMolnupiravir [Pending addition]
EXPERIMENTALPeramivir (RAPIVAB®) [Pending addition]
EXPERIMENTALLaninamivir (INAVIR®) [Pending addition]
EXPERIMENTALOseltamivir and Baloxavir [Pending addition]
EXPERIMENTALOseltamivir and Favipiravir [Pending addition]
EXPERIMENTALFavipiravir and Baloxavir [Pending addition]
EXPERIMENTALNegative control group
NO INTERVENTIONNo treatment (except antipyretics- paracetamol)
Interventions
Oral baloxavir: * \<80kg- single dose of 40mg on D0 * ≥80kg- single dose of 80mg on D0
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
Eligibility Criteria
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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Universidade Federal de Minas Gerais
Minas Gerais, Brazil
Laos-Oxford-Mahosot Wellcome Trust Research unit
Vientiane, Laos
Sukraraj Tropical & Infectious Disease Hospital
Kathmandu, Nepal
Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 13, 2022
Study Start
February 22, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 14, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Refer to MORU data sharing policy with other researchers to use in the future. https://wellcome.ac.uk/press-release/statement-data-sharing-public-health-emergencies).
With patient's consent, clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. https://wellcome.ac.uk/press-release/statement-data-sharing-public-health-emergencies). The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the site PI and key members of the research team. The database may be shared with researchers not directly involved in this study after the main paper has been published and in accordance with MORU guidelines on data sharing.