A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

Launched by UNIVERSITY OF OXFORD · Dec 5, 2022

Keywords

ClinConnect Summary

The clinical trial, called the AD ASTRA study, is investigating the effectiveness of different antiviral treatments for patients with early symptoms of influenza (the flu). Researchers want to find out how well these treatments work compared to not receiving any treatment at all. They are looking specifically at adults aged 18 to 60 who have tested positive for influenza and have shown at least one flu symptom, such as fever, cough, or fatigue, within the last four days. Participants need to be able to move around without assistance and agree to follow the study guidelines.

If you join this trial, you will receive one of the antiviral treatments or no treatment at all, and researchers will monitor your health closely. It's important to note that certain conditions, like having serious health issues or being pregnant, may prevent you from participating. This study is part of a larger effort supported by the Wellcome Trust to find effective therapies for influenza, especially in patients who are considered low-risk.

Gender

ALL

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 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