NCT04701606

The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine-artesunate (Artecom®) in COVID-19 Patients

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\<Stage 1\> In Stage 1, the trial will be conducted in 20 participants for 28 days in a single arm, open-label design. Artecom® will be administered orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days. After the completion of the final participant in Stage 1, the DSMB will review the safety data from Stage 1 and determine whether to proceed to Stage 2. \<Stage 2\> In Stage 2, a total of 382 participants will be enrolled and randomized in a double blinded manner to receive either Artecom® or placebo (1:1 ratio) orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days. A second DSMB meeting and review of all available blinded safety data will occur after 191 participants have completed Day 28. A final DSMB meeting will be held after the completion of a study assessment by the last participant.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Artecom® (pyronaridine-artesunate)	\* Participant body weight (Artecom® dose) * ≥ 65kg (Artecom® 4 tablets: Pyronaridine 720mg/ Artesunate 240mg) * ≥ 45kg and \< 65kg (Artecom® 3 tablets: Pyronaridine 540mg/ Artesunate 180mg)
DRUG	Placebo	\* Participant body weight (Placebo dose) * ≥ 65kg (Placebo 4 tablets) * ≥ 45kg and \< 65kg (Placebo 3 tablets)

Timeline

• Start date: 2021-03-29
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2021-01-08
• Last updated: 2021-09-30

Locations

4 sites across 1 country: Philippines