NCT05648448 A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza
| NCT ID | NCT05648448 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Oxford |
| Condition | Influenza |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 3,000 participants in total. It began in 2023-02-22 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05648448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Influenza. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05648448 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05648448 currently recruiting?
Yes, NCT05648448 is actively recruiting participants. Contact the research team at william@tropmedres.ac for enrollment information.
Where is the NCT05648448 trial being conducted?
This trial is being conducted at Minas Gerais, Brazil, Vientiane, Laos, Kathmandu, Nepal, Bangkok, Thailand.
Who is sponsoring the NCT05648448 clinical trial?
NCT05648448 is sponsored by University of Oxford. The trial plans to enroll 3,000 participants.