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

NCT04701606 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2021-09-30

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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)

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Belen L Dofitas, MD, PhD · Philippine General Hospital, University of the Philippines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2022-04-15
Completion
2022-04-15

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701606 on ClinicalTrials.gov