Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) ¿ TKM

Open-label, single arm trial to investigate the efficacy of TKM-130803 with a concurrent observational study of Ebolavirus Disease in an outbreak setting in West Africa.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201501000997429

Enrollment

100

Registered

2015-01-16

Start date

2015-02-16

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Ebola Ebola

Interventions

TKM-100802

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Laboratory confirmed infection with Ebolavirus Informed consent provided by patient >18 years) or representative (too unwell) Informed consent from parent or guardian (child) Has no underlying condition that could jeopardize patient or staff safety Able to comply with protocol requirements

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
TKM: To evaluate the impact of TKM treatment on early mortality in EVD;Observational: To characterize the early mortality of EVD in an ETC	—

Secondary

Measure	Time frame
TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: a) Time to recovery ;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: b) Late mortality;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: c) Viral load;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: d) EVD symptoms;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: e) EVD antibody response;To assess the safety of TKM treatment of adults and children.;Observational: To characterise the natural history of EVD in an ETC - a) Time to recovery ;Observational: To characterise the natural history of EVD in an ETC - b) Late mortality;Observational: To characterise the natural history of EVD in an ETC - c) Viral load ;Observational: To characterise the natural history of EVD in an ETC - c) Viral load;Observational: To characterise the natural history of EVD in an ETC - d) EVD symptoms;Observational: To characterise the natural history of EVD in an ETC - e) EVD antibody response	—

Measure

Time frame

TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: a) Time to recovery ;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: b) Late mortality;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: c) Viral load;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: d) EVD symptoms;TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: e) EVD antibody response;To assess the safety of TKM treatment of adults and children.;Observational: To characterise the natural history of EVD in an ETC - a) Time to recovery ;Observational: To characterise the natural history of EVD in an ETC - b) Late mortality;Observational: To characterise the natural history of EVD in an ETC - c) Viral load ;Observational: To characterise the natural history of EVD in an ETC - c) Viral load;Observational: To characterise the natural history of EVD in an ETC - d) EVD symptoms;Observational: To characterise the natural history of EVD in an ETC - e) EVD antibody response

—

Countries

Sierra Leone

Contacts

Public ContactRaul Pardinaz-Solis

University of Oxford

raul.pardinaz-solis@ndm.ox.ac.uk+441865612977

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026