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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201501000997429
• Date of registration: 16/01/2015
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) ¿ TKM
• Scientific title: 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.
• Date of first enrolment: 16/02/2015
• Target sample size: 100
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=997
• Study type: Interventional
• Study design: Single group: all participants receive same intervention throughout study,Non-randomised
• Phase: Not Applicable

Countries of recruitment

Sierra Leone

Contacts

• Name: Peter Horby
• Affiliation: University of Oxford

• Name: Raul Pardinaz-Solis
• Affiliation: University of Oxford

Key inclusion & exclusion 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: None

Age minimum: 0 Year(s)
Age maximum: 99 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
Ebola

Ebola

Intervention(s)

TKM-100802

Primary Outcome(s)

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 Outcome(s)

Observational: To characterise the natural history of EVD in an ETC - c) Viral load

TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: c) Viral load

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 - e) EVD antibody response

Observational: To characterise the natural history of EVD in an ETC - d) EVD symptoms

To assess the safety of TKM treatment of adults and children.

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: e) EVD antibody response

Observational: To characterise the natural history of EVD in an ETC - b) Late mortality

TKM 1. To evaluate the impact of TKM-130803 treatment of adults and children on: d) EVD symptoms

Source(s) of Monetary Support

Wellcome Trust

Ethics review

Status: Approved
Approval date:
Contact:

Sierra Leone Ethics and Scientific Review Committee

Status: Approved
Approval date: 20/02/2015
Contact:

Oxford Tropical Research Ethics Committee