Comparing antiviral treatments for early symptomatic influenza

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to quantitatively assess the antiviral effects of various licensed and investigational antiviral treatments in low-risk patients with uncomplicated influenza. It employs a randomised, open-label, controlled, group sequential, adaptive platform design to compare the efficacy of antiviral medications such as oseltamivir, zanamivir, and molnupiravir against a control group receiving no treatment. The study will focus on patients who present with early symptoms of influenza and have confirmed viral infections. The goal is to provide comparative data that can inform treatment guidelines and decision-making for antiviral therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Universidade Federal de Minas Gerais
  Minas Gerais, Brazil Recruiting
• Laos-Oxford-Mahosot Wellcome Trust Research unit
  Vientiane, Laos Recruiting
• Sukraraj Tropical & Infectious Disease Hospital
  Kathmandu, Nepal Recruiting
• Faculty of Tropical Medicine, Mahidol University
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: William Schilling, MD
• Email: william@tropmedres.ac
• Phone: +662 203 6333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.