Efficacy of Favipiravir Against Severe Ebola Virus Disease

NCT02662855 | Completed Phase 2 DMC

• 1 other identifier: IPT-125
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the most difficult aspect for clinical management of EVD due to its high fatality rate.

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (1)

• Case fatality rate

  14 days

Secondary Outcomes (1)

• Blood viral load

  1-3 days

Study Arms (2)

Control

ACTIVE COMPARATOR

WHO-recommended therapies, mainly symptomatic and supportive treatments. Briefly: body fluid management (intravenous or oral, depending on patient status), balanced nutrition (including glucose, electrolytes, vitamin, et al.), preventing intravascular volume depletion, correcting profound electrolyte abnormalities, avoiding the complications of shock, defervesce, anti-diarrheal, acesodyne, anti-anxiety. For patients with positive Plasmodium detection or bacterial infection, apply artemether-lumefantrine or antibiotics respectively. Details refer to 'Manual for the care and management of patients in Ebola Care Units/Community Care Centres, Interim emergency guidance' and 'Clinical Management of Patients with Viral Haemorrhagic Fever: A Pocket Guide for the Front-line Health Worker' by WHO.

Other: WHO-recommended therapies

Treatment

EXPERIMENTAL

WHO-recommended therapies plus oral administration of Favipiravir

Other: WHO-recommended therapies; Drug: Favipiravir

Interventions

WHO-recommended therapies OTHER

symptomatic and supportive treatments according to the WHO manual

Control; Treatment

Favipiravir DRUG

oral administration of Favipiravir tablets

Also known as: T-705

Treatment

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or famale，13 -75 years of age
• Clinical diagnosis of EVD
• Positive blood viral RNA detection
• With any one of the symptoms below:
• Hemorrhage (including hematemesis, hemoptysis, hematochezia, hematuria, mucocutaneous hemorrhage), severe dehydration (including oliguria, anuria, feebleness, hypotension, tachycardia), consciousness disorders (including coma, delirium, confusion, convulsion), shock, and high blood viral load (Ct value below 20)
• Not received any therapies for EVD
• Provided written informed consent, by guardian or the patient himself
• Be able to administrate and tolerate oral administration of tablets

You may not qualify if:

• Severe vomiting
• Pregnancy and breast-feeding
• Received antiviral treatment against EVD

Sponsors & Collaborators

• Beijing Institute of Pharmacology and Toxicology: lead
• Beijing 302 Hospital: collaborator
• 307 Hospital of PLA: collaborator
• Sierra Leone-China Friendship Hospital: collaborator
• Centers for Disease Control and Prevention, China: collaborator

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

favipiravir

Condition Hierarchy (Ancestors)

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

Study Officials

• Wu Zhong, PhD

  Beijing Institute of Pharmacology and Toxicology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01