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To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria

NCT04675931 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-04-09

Study results available
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Summary

The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.

The study also intended to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria.

Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable artesunate is the standard of care for the treatment of severe malaria and is highly efficacious. However, the spread of artemisinin-resistance in Plasmodium falciparum in Asian countries poses a threat for future treatment of patients with this life-threatening disease. To mitigate this risk, there is a need for another drug in malaria-endemic countries. Cipargamin treatment results in rapid clearance of parasites, including artemisinin-resistant parasites.

Conditions

  • Severe Malaria

Interventions

DRUG

Cipargamin

Cipargamin, 20 mg or 40 mg, by intravenous administration of solution for injection

DRUG

IV Artesunate

Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution

DRUG

Coartem

Oral standard of care (Coartem tablets, dosed per weight, as per label)

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2025-07-24
Completion
2025-08-20

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Democratic Republic of the Congo
  • Kenya
  • Mozambique
  • Rwanda
  • Uganda

Study Locations

More Related Trials

Entities

Companies

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 NCT04675931 on ClinicalTrials.gov