COVID-19 STAndard of Care in Sub-Saharan Africa | NCT04885543

Studies
COVID-19 STAndard of Care in Sub-Saharan Africa

NCT04885543

Sponsor

Alliance for International Medical Action

Status

Completed

Last Update Posted

May 13, 2021Actual

Enrollment

2,495Actual

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

Countries

Burkina Faso
Guinea

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

May 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

Mar 1, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

May 6, 2021

First Submission Date that Met QC Criteria

May 11, 2021

First Posted Date

May 13, 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

May 11, 2021

Last Update Posted Date

May 13, 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 was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.

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

2,495Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	In hospital mortality	During hospitalization, with an average of 11 days

Secondary Outcomes

Measure	Description	Time Frame
Clinical worsening	Combination of an SpO2 <94% at least once during follow-up (including at baseline), use of oxygen therapy at any time during follow-up, or death	Hospitalization, with an average of 11 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SARS-CoV-2 positive at RT-PCR

Exclusion Criteria:

Asymptomatic patients

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

People hospitalized with symptomatic of COVID-19 and a positive RT-PCR SARS-CoV-2 test

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denis Malvy, Pr	CHU Bordeaux, INSERM 1219	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Tengandogo		Ouagadougou		BP104	Burkina Faso
Clinique Princesse Sarah

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
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided