Status:
RECRUITING
A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
Lead Sponsor:
University of Oxford
Conditions:
Influenza
Influenza, Human
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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...
Detailed Description
Several influenza antivirals are licensed, differing in availability and routes of administration. Direct comparisons of antiviral and clinical efficacy between the multiple available antivirals are l...
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
Key Trial Info
Start Date :
February 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT05648448
Start Date
February 22 2023
End Date
January 1 2027
Last Update
April 14 2026
Active Locations (4)
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1
Universidade Federal de Minas Gerais
Minas Gerais, Brazil
2
Laos-Oxford-Mahosot Wellcome Trust Research unit
Vientiane, Laos
3
Sukraraj Tropical & Infectious Disease Hospital
Kathmandu, Nepal
4
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400