A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
NCT ID: NCT05648448
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
3000 participants
INTERVENTIONAL
2023-02-22
2027-01-01
Brief Summary
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AD ASTRA study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oseltamivir (TAMIFLU®)
Oseltamivir
Oral oseltamivir 75mg BD for 5/7
Favipiravir
Favipiravir
Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Zanamivir (RELENZA®) [Pending addition]
Zanamivir
Inhaled zanamivir 10mg BD for 5/7
Baloxavir (XOFLUZA®)
Baloxavir
Oral baloxavir:
* \<80kg- single dose of 40mg on D0
* ≥80kg- single dose of 80mg on D0
Molnupiravir [Pending addition]
Molnupiravir
Oral molnupiravir 800mg BD for 5/7
Peramivir (RAPIVAB®) [Pending addition]
Peramivir
Intravenous peramivir 600mg once only
Laninamivir (INAVIR®) [Pending addition]
Laninamivir
Inhaled laninamivir 40mg once only
Oseltamivir and Baloxavir [Pending addition]
Oseltamivir and Baloxavir
Oseltamivir 75mg BD for 5/7 and
Baloxavir:
* \<80kg- single dose of 40mg on D0
* ≥80kg- single dose of 80mg on D0
Oseltamivir and Favipiravir [Pending addition]
Oseltamivir and Favipiravir
Oseltamivir 75mg BD for 5/7 and
favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Favipiravir and Baloxavir [Pending addition]
Favipiravir and Baloxavir
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
Negative control group
No treatment (except antipyretics- paracetamol)
No interventions assigned to this group
Interventions
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Oseltamivir
Oral oseltamivir 75mg BD for 5/7
Favipiravir
Oral favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Zanamivir
Inhaled zanamivir 10mg BD for 5/7
Baloxavir
Oral baloxavir:
* \<80kg- single dose of 40mg on D0
* ≥80kg- single dose of 80mg on D0
Molnupiravir
Oral molnupiravir 800mg BD for 5/7
Peramivir
Intravenous peramivir 600mg once only
Laninamivir
Inhaled laninamivir 40mg once only
Oseltamivir and Baloxavir
Oseltamivir 75mg BD for 5/7 and
Baloxavir:
* \<80kg- single dose of 40mg on D0
* ≥80kg- single dose of 80mg on D0
Oseltamivir and Favipiravir
Oseltamivir 75mg BD for 5/7 and
favipiravir 1800mg BD D0 and 800mg BD for a further 4/7
Favipiravir and Baloxavir
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
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Locations
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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, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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VIR22003
Identifier Type: -
Identifier Source: org_study_id
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