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. 2024 Feb 5;2024(2):CD015219. doi: 10.1002/14651858.CD015219.pub2

NCT05279235.

Study name Efficacy and safety of JT001 (VV116) compared with favipiravir
Methods Double‐blinded, randomized, phase III
Participants People with moderate to severe COVID‐19
Interventions JT001 (VV116)
Favipiravir
Placebo
Outcomes Primary
  • Progression of COVID‐19: percentage of the participants who have progression of COVID‐19, defined as progress to critical COVID‐19 or death from any cause, through Day 29


Secondary
  • Adverse events (AEs) and serious adverse events (SAEs). Time frame: up to 29 days

  • Progress, Death: percentage of participants who experience these events by Day 29

    • Progress to critical COVID‐19

    • Death from any cause

  • WHO 11‐point ordinal outcome scale: change in the WHO 11‐point ordinal outcome scale from baseline to Days 3, 5, 7, 10 and 29 (0 = uninfected, 10 = dead). Time frame: Days 3, 5, 7, 10 and 29

  • Change in chest CT scan (percentage of lung involved) from baseline to Days 7 and 10

  • SARS‐CoV‐2 clearance: percentage of participants who achieve SARS‐CoV‐2 clearance at Days 3, 5,7 and 10


Other outcome measures:
  • SARS‐CoV‐2 viral genetic variation. Time frame: Day 1

Starting date 14 March 2022
Contact information Juan Ma, Master
Shanghai Junshi Bioscience Co., Ltd
Notes