Ebola Virus DiseaseEVISTANCT04815174
Observational Study of the Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease
An observational study of Ebola Virus Disease, run by Alliance for International Medical Action at 1 site in Democratic Republic of the Congo.
Trial summary
This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ebola Virus Disease
- How many people
- 711 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Aug 2018to 31 Dec 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with positive RT-PCR admitted in ETC's during the inclusion period were included in the study
Who may be able to join
- Laboratory confirmed Ebola Virus Disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
BENI ETC
Beni, North Kivu
About this study
This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019 has on the contrary seen the development of a number of medical care strategies, in parallel with the deployment of specific treatments. This study aims to describe a cohort of patients receiving this upgraded supportive care during the tenth epidemic in the DRC.
- Conditions
- Ebola Virus Disease
- Being tested
- Standard of Care
- 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.
Standard of CareOther
(i) advanced clinical and biological monitoring system (ii) symptomatic treatment adapted to the patient's needs, such as antibiotic therapy, oxygen therapy and blood transfusion; (iii) dialysis or mechanical ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Any type mortality during hospitalization
Measured: Through the end of the hospitalization, with an average of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815174
- Sponsor's protocol ID
- ALIMA01
- Acronym
- EVISTA
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease
- ClinicalTrials.gov ID
- NCT04815174
- Acronym / sponsor ID
- EVISTA / ALIMA01
- Conditions
- Ebola Virus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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.
This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019 has on the contrary seen the development of a number of medical care strategies, in parallel with the deployment of specific treatments. This study aims to describe a cohort of patients receiving this upgraded supportive care during the tenth epidemic in the DRC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with positive RT-PCR admitted in ETC's during the inclusion period were included in the study
Key inclusion criteria (1 listed)
- Laboratory confirmed Ebola Virus Disease
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Standard of Care(i) advanced clinical and biological monitoring system (ii) symptomatic treatment adapted to the patient's needs, such as antibiotic therapy, oxygen therapy and blood transfusion; (iii) dialysis or mechanical ventilation. | Other | – |
Primary outcome
Mortality
Time frame: Through the end of the hospitalization, with an average of 11 days
Any type mortality during hospitalization
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 24 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Virus Disease, run by Alliance for International Medical Action at 1 site in Democratic Republic of the Congo.
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 1 inclusion and 1 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Mortality (time frame: Through the end of the hospitalization, with an average of 11 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 24 Mar 2021.