Multiple Treatments for Ebola Virus Disease (EVD)

Clinical Research Management, Inc.

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ebola Virus Disease

Treatments: Drug: Atorvastatin and Irbesartan; Other: IV fluids and laboratory testing; Drug: Sunitinib and Erlotinib; Drug: Azithromycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02380625

EVD-003

Details and patient eligibility

About

The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD)

Full description

The ongoing epidemic of EVD has ravaged parts of West Africa, with initial cases reported in December 2013. There is no licensed specific therapy for the disease, which has a case-fatality rate of approximately 50-70%. Although anecdotal clinical data, recent studies in animal models, and in vitro screening suggest that treatment of EVD patients with anti-viral agents, immune modifying agents, and/or convalescent blood products may be effective, they have not been evaluated in clinical trials. This multi-arm clinical trial will evaluate the efficacy and safety of multiple regimens, both as mono-therapy and combination therapy. Provision of these regimens, if found effective and safe, would have a major impact on the current and future epidemics by providing effective treatment options.

As described for previous adaptive trials, a randomization probability for each of the treatment regimens is created based on 14-day mortality, and is used for weighting randomization of subsequently enrolled participants. Participants will continually be preferentially assigned to regimens with better initial performance. New agents can be added or existing agents removed as the trial evolves.

Enrollment: 150 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 6 months and >8kg in weight
• Confirmed case of EVD
• Admission to the hospital < 48 hours prior to enrollment
• Participant or family member/guardian able and willing to provide signed informed consent

Exclusion criteria

• Prior treatment with any other specific experimental anti-EVD product, or expectation to receive another experimental anti-EVD product during the course of the study (this does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD)
• Unresponsive
• In the treating physicians opinion, an inability to comply with the study treatment regimen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Azithromycin

Experimental group

Description:

Azithromycin, IV fluids and laboratory testing

Treatment:

Other: IV fluids and laboratory testing

Drug: Azithromycin

Sunitinib and Erlotinib

Experimental group

Description:

Sunitinib, Erlotinib, IV fluids and laboratory testing

Treatment:

Other: IV fluids and laboratory testing

Drug: Sunitinib and Erlotinib

Atorvastatin and Irbesartan

Experimental group

Description:

Atorvastatin, Irbesartan, IV fluids and laboratory testing

Treatment:

Other: IV fluids and laboratory testing

Drug: Atorvastatin and Irbesartan

IV fluids and laboratory testing

Other group

Description:

no additional treatment

Treatment:

Other: IV fluids and laboratory testing