Observational Study of the Clinico-biological Evolution a... | NCT04815174

Studies
Observational Study of the Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease

NCT04815174

Sponsor

Alliance for International Medical Action

Status

Completed

Last Update Posted

Mar 24, 2021Actual

Enrollment

711Actual

Phase

Not provided

Conditions

Ebola Virus Disease

Interventions

Standard of Care

Countries

Democratic Republic of the Congo

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

711Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care	Other	(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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Any type mortality during hospitalization	Through the end of the hospitalization, with an average of 11 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Laboratory confirmed Ebola Virus Disease

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with positive RT-PCR admitted in ETC's during the inclusion period were included in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BENI ETC		Beni	North Kivu		Democratic Republic of the Congo

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019142	Hemorrhagic Fever, Ebola

Ancestor Terms

ID	Term
D006482	Hemorrhagic Fevers, Viral
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided