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Multiple Treatments for Ebola Virus Disease (EVD)

NCT02380625 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-03-05

No results posted yet for this study

Summary

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

Conditions

  • Ebola Virus Disease

Interventions

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

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

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

IV fluids and laboratory testing

All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • University of Sierra Leone

    collaborator OTHER

  • Syneos Health

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Clinical Research Management, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Woods, MD, MPH · Duke University

  • John M Griffiss, MD · Clinical Research Management

  • David L Hoover, MD · Clinical Research Management

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-01-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380625 on ClinicalTrials.gov