Essential medicines and health products

Table of drug clinical trials

Product / Company

Phase

Trial Location

Description

Favipiravir

Fujifilm/Toyama, Japan

Phase II

By INSERM in

Guinea: Conakry, Guéckedou, Macenta, Nzérékoré

Used to treat influenza.

Clinical trials began in December 2014. Preliminary data presented in February 2015 does not permit a firm conclusion regarding efficacy and more data is required; trial continues.

The drug has been administered to around 200 patients who received 9 days of oral treatment. There is no control group.

The trial is at ETUs in Gueckedou, Nzerekore, Donka, and Conakry and is led by INSERM with funding from the European Commission.

The EU has announced preliminary findings from these trials which show the antiviral may be effective in treating patients with early stage EVD. In adults and adolescents with a low to moderate viral load, the case fatality rate was 15% (vs 30%, historically). WHO is taking a cautious interpretation given the lack of concurrent controls in the study.

TKM-100802 (siRNA)

Tekmira, Canada

Phase II

By Oxford University in

Kerry Town, Sierra Leone

siRNA – a short RNA sequence that cleaves Ebola RNA in cells and prevents virus multiplication. Treats 100% of infected monkeys.

A clinical trial started in early March 2015 in Port Loko, Sierra Leone, led by Oxford University with funding from the Wellcome Trust.

The trial was halted on 19 June on the grounds of having met one of the clinical endpoints. Continuing enrolment was not likely to demonstrate an overall therapeutic benefit.

ZMapp

MappBio USA

Phase II

By NIAID in

Liberia, Sierra Leone and the United States of America

Cocktail of three monoclonal antibodies with neutralizing activity against Ebola virus in animal models. Treats 100% of infected non-human primates (NHP). The product has been used on several patients under compassionate use.

A multi-country, multisite randomized controlled trial opened to enrollment in Liberia and the United States in February 2015 and in Sierra Leone in March 2015. Enrollment is ongoing – currently, more than 35 patients have been enrolled.

No data on efficacy is available yet.

Preparations to extend this trial to Guinea (in collaboration with INSERM) are in progress.

MIL-77

MabWorks, China

Phase I

 

Cocktail of three monoclonal antibodies with the same sequence as the monoclonals in Zmapp, yet made in CHO cells.

Efficacy in monkeys comparable to Zmapp.

To date, used in two expatriated patients under compassionate use.

IND for Phase I filed in China.

Prioritized for use on Ebola patients in condition of not interfering with the clinical assessment of efficacy of Zmapp.

BCX-4430

Biocryst, USA

Phase I

By Quotient Clinic in the UK

Broad-spectrum direct-acting nucleoside analogue.

Phase I safety trial is underway. No efficacy trial is planned until safety data have been analysed.

Interferons

Phase II

By Guinea MOH in

Coyah, Guinea

Approved for treatment of HepB and C and multiple sclerosis.

Guinean authorities, in collaboration with Canadian scientists, launched a clinical study of an interferon in Ebola-infected patients. Due to risks of symptom exacerbation, enrollment limited to patients with recent symptom onset. To date, 9 patients have been enrolled in the trial.

Amiodarone

Observational

At the Lakka & Goderich ETU in

Sierra Leone

Used to treat cardiac dysrhythmia.

Was used compassionately in approximately 80 patients in Sierra Leone and reportedly reduced case fatality ratio when compared with local historical norms. The statistical significance of this result is not known due to variations in case fatality rates across sites and over time.

This treatment is no longer being used.

Atorvostatin + Irbesartan +/- Clomiphene

Sierra Leone

Approved for cholesterol control / hypertension / infertility, respectively.

Apparently used to treat some patients in Sierra Leone, however, there has been no confirmation from the treatment centres that such studies took place, and no clinical data on the patients are available. Therefore, no conclusion on utility, safety or efficacy is possible.

FX06

Peptide for use in treating vascular leakage.

Administered compassionately to two patients. No conclusions can be drawn yet.

Zmab

Non-GMP experimental monoclonal antibody product with no plans for GMP production.

Administered on a compassionate basis to a few patients when other products are not available.

Amodiaquine

 

Médecins Sans Frontiéres (MSF)

Antimalarial products were provided to all patients entering Ebola treatment centres. When MSF switched from an antimalarial containing lemefantrine to one containing amodiaquine, the case fatality rates dropped.

It is not known if this is due to efficacy of amodiaquine against Ebola or to toxicity of lemefantrine in patients with EVD.

Brincidofovir

Chimerix, USA

Phase II

By Oxford University at the

ELWA 3 Clinic, Monrovia, Liberia

An antiviral used to treat CMV.

Clinical trial halted and abandoned; the drug has been deprioritized for use in Ebola treatment.