Multiple Treatments for Ebola Virus Disease (EVD)

March 1, 2015 updated by: Clinical Research Management, Inc.

An Adaptive Randomized Trial Comparing Multiple Treatments for Ebola Virus (EBOV) Infected Children and Adults

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Azithromycin
Azithromycin, IV fluids and laboratory testing
Drug: Azithromycin
Adults (>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to <18 yrs): 30mg/kg (oral suspension) daily for 5 days
Other Names:
  • Zithromax
Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
EXPERIMENTAL: Sunitinib and Erlotinib
Sunitinib, Erlotinib, IV fluids and laboratory testing
Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
Drug: Sunitinib and Erlotinib
Sunitinib - Adults (>18 yrs): 1 x 50mg tablet daily for 7 days; Children (6 months to <18 yrs): 0.83 mg/kg (oral suspension) daily for 7 days. Erlotinib - Adults (>18 yrs): 1 x 150mg tablet daily for 7 days; Children (8kg to <20kg): 3.5 mg/kg daily for 7 days; Children (>20kg to <30kg): 3.0 mg/kg daily for 7 days; Children (>30kg to < 18 yrs): 25 mg/kg daily for 7 days
Other Names:
  • Tarceva
  • Sutent
EXPERIMENTAL: Atorvastatin and Irbesartan
Atorvastatin, Irbesartan, IV fluids and laboratory testing
Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
Drug: Atorvastatin and Irbesartan
Atorvastatin - Adults (>18 yrs): 1 x 40mg tablet daily until discharge; Children (6 years to <18 yrs): 1 x 40mg tablet daily until discharge; Irbesartan - Adults (>18 yrs): 1 x 150mg tablets daily until discharge; Children (6 years to <18 yrs): 1 x 75mg tablet daily until discharge.
Other Names:
  • Lipitor
  • Avapro
OTHER: IV fluids and laboratory testing
no additional treatment
Other: IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death by 14 days
Time Frame: 14 days after starting treatment regimen
14 days after starting treatment regimen

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in viral load
Time Frame: 14 days after starting treatment regimen
14 days after starting treatment regimen
2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities
Time Frame: 14 days after starting treatment
14 days after starting treatment

Other Outcome Measures

Outcome Measure
Time Frame
Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator
Time Frame: 14 days after starting treatment
14 days after starting treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Management, Inc.

Collaborators

Duke University
Bill and Melinda Gates Foundation
Syneos Health
University of Sierra Leone
University of North Carolina

Investigators

  • Study Chair: John M Griffiss, MD, Clinical Research Management
  • Study Chair: David L Hoover, MD, Clinical Research Management

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ANTICIPATED)

January 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (ESTIMATE)

March 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 1, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVD-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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