A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza (AD ASTRA)
Influenza, Influenza, Human
About this trial
This is an interventional treatment trial for Influenza focused on measuring Influenza, Phase 2, Antiviral Pharmacodynamics
Eligibility 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 50 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 Haemaglobin <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
Sites / Locations
- Faculty of Tropical Medicine, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Oseltamivir (TAMIFLU®)
Favipiravir
Zanamivir (RELENZA®)
Baloxavir (XOFLUZA®)
Molnupiravir
Peramivir (RAPIVAB®)
Laninamivir (INAVIR®)
Negative control group
No treatment (except antipyretics- paracetamol)