Assessment of Respiratory SYNcytial virus antivirALs: A phase 2 multi-centre adaptive randomised platform trial For the assessment of antiviral pharmacodynamics in aCute symptomatic RSV infection (ARSYNAL-FC)

Principal Investigator(s):  Associate Professor Abhilasha Karkey

Funder(s):  University of Oxford

Location(s): Thailand, Brazil, Laos, Pakistan, Nepal

Partners and collaborators

1.Mahidol Oxford Tropical Research Unit

2Sukraraj Tropical and Infectious Disease Hospital

 

This is a multi-center adaptive randomized platform trial that aims to evaluate the in-vivo efficacy of antivirals in acute symptomatic RSV infection.

In this randomised, open-label, controlled, group-sequential adaptive platform trial, the efficacy of currently licensed interventions, including repurposed drugs with activity against RSV, as well as investigational interventions demonstrating potential activity in pre-clinical and early clinical studies, will be assessed and compared relative to one another and to the control arm (no antiviral treatment).

This study will be conducted in low-risk patients with RSV, recruited from outpatient flu clinic at Sukraraj Tropical and Infectious Disease Hospital (STIDH). These will be adults 18 to <65 years old with early symptomatic RSV (within 4 days (96 hours) since the reported onset of symptoms), who are positive by an RSV rapid antigen test OR a positive RT-PCR test for RSV within the last 24 hours with a Ct value less than 30. Patients who can be followed up reliably for 28 days, will be included.

The list of interventions i.e., antivirals to be used in this study are Ribavirin, Molnupiravir and Favipiravir. All drugs will be administered orally.

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PELAJARI SELENGKAPNYA

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