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

NCT05014373.

Study name Philippine trial to determine efficacy and safety of favipiravir for COVID‐19
Methods Open‐label RCT
Participants
  • Age: 18 to 74 years (at the time of informed consent)

  • Gender: male or female

  • People with SARS‐CoV‐2‐positive nasopharyngeal swab by RT‐PCR test with non‐severe presentation upon admission to clinical trial site hospitals or trial‐supervised quarantine facilities or under trial‐supervised home isolation

Interventions Favipiravir plus best supportive care versus best supportive care
Outcomes Primary
  • Time from initiation of treatment to clinical improvement, maintained for at least 48 hours. Criteria for clinical improvement (all three must be reached): body temperature: axillary ≤ 37.4°C; oxygen saturation measured by pulse oximeter of > 96% without oxygen inhalation; chest imaging findings with changes showing improvement. Time frame: 4 to 28 days


Secondary
  • Clinical effect on patient status as measured by 7‐point scale: change in the study‐specific 7‐point scale from initiation of treatment to end of treatment. Time frame: 4 to 14 days of therapy

  • Number of participants with conversion to negative level of SARS‐COV2 viral genome. Time frame: 4 to 14 days of therapy

  • Number of participants with changes in NEWS. Time frame: 4 to 14 days of therapy

  • Number of participants with improvement in chest imaging findings. Time frame: 4 to 14 days of therapy

Starting date 12 October 2020
Contact information Regina Berba, MD
+639985381599
rpberba@gmail.com
Notes