Multiple Treatments for Ebola Virus Disease (EVD)

Sponsor
Clinical Research Management, Inc.
Study ID
NCT02380625
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Ebola Virus Disease

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azithromycin — DRUG
    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
  • Sunitinib and Erlotinib — DRUG
    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
  • Atorvastatin and Irbesartan — DRUG
    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.
  • IV fluids and laboratory testing — OTHER
    All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.

Study Details

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

Key Dates

First listed
Mar 5, 2015
Start date
Apr 30, 2015
Status verified
Mar 2015
Primary completion
Jan 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Azithromycin
    Azithromycin, IV fluids and laboratory testing
  • Experimental: Sunitinib and Erlotinib
    Sunitinib, Erlotinib, IV fluids and laboratory testing
  • Experimental: Atorvastatin and Irbesartan
    Atorvastatin, Irbesartan, IV fluids and laboratory testing
  • Other: IV fluids and laboratory testing
    no additional treatment

Primary Outcome Measure

Death by 14 days [ Time Frame: 14 days after starting treatment regimen ]

Central Contacts