Multiple Treatments for Ebola Virus Disease (EVD)

NCT02380625 | Unknown Phase 1 DMC

• 1 other identifier: EVD-003
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Ebola; EVD; Adaptive design; therapeutics

Outcome Measures

Primary Outcomes (1)

• Death by 14 days

  14 days after starting treatment regimen

Secondary Outcomes (2)

• Reduction in viral load

  14 days after starting treatment regimen

• 2-week post discharge clinical sequelae, including signs and symptoms and laboratory abnormalities

  14 days after starting treatment

Other Outcomes (1)

• Severe adverse events that are inconsistent with EVD and are assessed as related to study agent(s) by the site principal investigator

  14 days after starting treatment

Study Arms (4)

Azithromycin

EXPERIMENTAL

Azithromycin, IV fluids and laboratory testing

Drug: Azithromycin; Other: IV fluids and laboratory testing

Sunitinib and Erlotinib

EXPERIMENTAL

Sunitinib, Erlotinib, IV fluids and laboratory testing

Drug: Sunitinib and Erlotinib; Other: IV fluids and laboratory testing

Atorvastatin and Irbesartan

EXPERIMENTAL

Atorvastatin, Irbesartan, IV fluids and laboratory testing

Drug: Atorvastatin and Irbesartan; Other: IV fluids and laboratory testing

IV fluids and laboratory testing

OTHER

no additional treatment

Other: IV fluids and laboratory testing

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

Also known as: Zithromax

Azithromycin

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

Also known as: Sutent, Tarceva

Sunitinib and Erlotinib

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.

Also known as: Lipitor, Avapro

Atorvastatin and Irbesartan

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.

Atorvastatin and Irbesartan; Azithromycin; IV fluids and laboratory testing; Sunitinib and Erlotinib

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Research Management, Inc.: lead
• Bill and Melinda Gates Foundation: collaborator
• Duke University: collaborator
• University of Sierra Leone: collaborator
• Syneos Health: collaborator
• University of North Carolina: collaborator

Related Publications (1)

• Berry SM, Petzold EA, Dull P, Thielman NM, Cunningham CK, Corey GR, McClain MT, Hoover DL, Russell J, Griffiss JM, Woods CW. A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response. Clin Trials. 2016 Feb;13(1):22-30. doi: 10.1177/1740774515621721. Epub 2016 Jan 14.

  PMID: 26768569 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

Azithromycin; Sunitinib; Erlotinib Hydrochloride; Atorvastatin; Irbesartan; Fluid Therapy

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines; Heptanoic Acids; Fatty Acids; Lipids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Spiro Compounds; Tetrazoles; Polycyclic Compounds; Drug Therapy; Therapeutics

Study Officials

• Christopher Woods, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

• John M Griffiss, MD

  Clinical Research Management

  STUDY CHAIR

• David L Hoover, MD

  Clinical Research Management

  STUDY CHAIR

Central Study Contacts

John M Griffiss, MD

CONTACT

1-800-431-9640; crapaud@loursage.org

Christopher W Woods, MD, MPH

CONTACT

919-668-7174; chris.woods@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 5, 2015

Record last verified: 2015-03