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XC221 (Triazavirin) for COVID-19 Treatment
NCT04487574Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2020
- Primary completion
- Oct 2020
- Countries
- 1
- Sponsor
- RSV Therapeutics LLC
- Modality
- Small Molecules
- Drugs
- favipiravir
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of favipiravir in coronavirus disease 2019 (COVID-19) (2 arms), sponsored by RSV Therapeutics LLC. Primary endpoint: Patient rate with a transition to category 3 or lower according to the WHO scale at Day 14. Started Jul 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
XC221
XC221 100 mg orally (1 tablet) 2 times a day + SoC
Placebo
Placebo orally (1 tablet) 2 times a day + SoC
03
Who it enrols
Adult patients (18-75) with confirmed moderate or severe COVID-19 (hospitalized, requiring oxygen but not invasive ventilation/ECMO), symptom onset ≤7 days, and no severe comorbidities or recent use of other antivirals/immunomodulators.
04
Endpoints
Primary
Patient rate with a transition to category 3 or lower according to the WHO scale
Secondary
Time till clinical improvement
Patient rate with clinical improvement
Patient rate with a negative test result for SARS-CoV-2
Duration of hospitalization
Patient rate transferred to the intensive care unit (ICU)
Presence of a fatal outcome
Patient rate requiring oxygen therapy
Patient rate requiring invasive ventilation
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