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TOKOMEZA - Ebola Disease Therapeutics Trial

TOKOMEZA - Ebola Disease Therapeutics Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202502676012681
Enrollment
75
Registered
2025-02-24
Start date
2025-02-24
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola

Interventions

Remdesivir
MBP134
Remdesivir and MBP134

Sponsors

Uganda Ministry of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i) Admitted to a hospital or Ebola Treatment Unit for treatment of Ebola Disease (ii) Positive Ebola RT-PCR (or neonate aged seven days or younger born to a woman with acute laboratory confirmed Ebola Disease) (iii) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if enrolled in the trial (e.g allergy to a study drug) (iv) Not known to have been enrolled in this protocol previously (v) Not known to have received antiviral (e.g remdesivir or monoclonal antibody) treatment for Ebola Disease during this infection (e.g. through Monitored Emergency Use of Unregistered and Investigational Interventions)

Exclusion criteria

Exclusion criteria: If the attending clinician believes that there is a specific contraindication to one of the active drug treatments and/or that the patient should definitely be receiving one of the active treatments, then they will not be eligible for randomisation in that comparison.

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 28 days following randomisation.

Secondary

MeasureTime frame
Time (days) from randomisation to viral clearance. Viral clearance, using results from routine clinical samples, is defined as the first negative Ebolavirus RT-PCR test without a subsequent positive test result or subsequent death. In the unlikely scenario that a patient is discharged home without two successive negative RT-PCR tests, the date of the first negative test or, if there is no negative test result, the date of medical discharge will be used.

Countries

Uganda

Contacts

Public ContactPauline Byakika Kibwika

Vice Chancellor

pauline.byakika@must.ac.ug256485421373

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026