The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients
Status:
Recruiting
Trial end date:
2022-04-15
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacy of
pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19).
Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name of
Pyramax® or Artecom® as a treatment for malaria. The study will be conducted in two stages:
open-label (Stage 1) and double-blind (Stage 2).
Up to approximately 402 participants (20 participants in Stage 1 and 382 participants in
Stage 2) are planned to be enrolled in the study and will be randomized to receive either
Artecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will be
determined by the participant's body weight, according to previously established guidelines.
An independent Drug Safety Monitoring Board (DSMB) will be established to review the safety
at regular intervals during the conduct of the trial. The DSMB will be subject to a Charter
and will review after 20 participants have been recruited, and thereafter when 191
participants have been recruited.
Ad-hoc DSMB meetings may be held at any time during the study if there are any major safety
concerns. A final DSMB will be conducted when all participants have been recruited in the
trial.