Ebola Virus DiseasePhase 2NCT02662855
Efficacy of Favipiravir Against Severe Ebola Virus Disease
A Phase 2 study testing WHO-recommended therapies and Favipiravir in people with Ebola Virus Disease, run by Beijing Institute of Pharmacology and Toxicology.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- WHO-recommended therapies and Favipiravir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe vomiting
- Pregnancy and breast-feeding
- Received antiviral treatment against EVD
About this study
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.
Read the detailed description
This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.
- Conditions
- Ebola Virus Disease
- Being tested
- WHO-recommended therapies, Favipiravir
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO-recommended therapiesOther
symptomatic and supportive treatments according to the WHO manual
FavipiravirDrug
Also called T-705
oral administration of Favipiravir tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WHO-recommended therapies |
| Treatment | Experimental | WHO-recommended therapies plus oral administration of Favipiravir Receives: Other: WHO-recommended therapies; Drug: Favipiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case fatality rate
Measured: 14 days
Secondary outcomes (1)
Blood viral load
Described by Ct (cycle threshold) value
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Pharmacology and Toxicology
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, 307 Hospital of PLA, Sierra Leone-China Friendship Hospital, Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
- Investigators
- Wu Zhong, PhD, Principal investigator, Beijing Institute of Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662855
- Sponsor's protocol ID
- IPT-125
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Favipiravir Against Severe Ebola Virus Disease
- ClinicalTrials.gov ID
- NCT02662855
- Acronym / sponsor ID
- IPT-125
- Conditions
- Ebola Virus Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Beijing Institute of Pharmacology and ToxicologyUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, 307 Hospital of PLA, Sierra Leone-China Friendship Hospital, Centers for Disease Control and Prevention, China
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: WHO-recommended therapiesWHO-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. |
| Treatment | Experimental | Other: WHO-recommended therapies, Drug: FavipiravirWHO-recommended therapies plus oral administration of Favipiravir |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- Severe vomiting
- Pregnancy and breast-feeding
- Received antiviral treatment against EVD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO-recommended therapiessymptomatic and supportive treatments according to the WHO manual | Other | Control, Treatment |
| FavipiravirAlso: T-705oral administration of Favipiravir tablets | Drug | Treatment |
Primary outcome
Case fatality rate
Time frame: 14 days
1 secondary outcome
Blood viral load
Time frame: 1-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Related trials for Ebola Virus Disease
Not yet recruitingPhase 1
A Study to Investigate the Safety and Immunogenicity of mRNA-1469 in African Participants 1 to 65 Years of Age
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 4
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
Ebola, Bundibugyo Virus Disease (BVD)
Not yet recruitingPhase 2/3
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 1
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
Sudan Virus Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu Zhong, PhD principal investigator
Beijing Institute of Pharmacology and Toxicology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WHO-recommended therapies and Favipiravir in people with Ebola Virus Disease, run by Beijing Institute of Pharmacology and Toxicology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case fatality rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.