Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings

NCT ID: NCT04568499

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

592 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-27

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will characterize risk factors for poor COVID-19 outcomes (hospitalization, death) and clinical progression of hospitalized COVID-19 patients in South Sudan and Eastern Democratic Republic of the Congo.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A prospective cohort design will be used to follow suspected, probable, and confirmed COVID-19 cases presenting for care at International Medical Corp \[supported\] health facilities in Juba, South Sudan and the Kivus in Eastern Democratic Republic of the Congo (DRC). This research seeks to assess risk factors for poor outcomes and characterize clinical disease progression of COVID-19 cases in resource-poor humanitarian contexts in Africa. Specifically, this study aims to characterize risk factors for poor COVID-19 outcomes, including both co-morbidities with evidence from high income settings, as well as prevalent conditions in humanitarian settings (e.g., acute malnutrition, malaria, HIV) for which data is not yet available. This research also aims to determine how the progression of confirmed COVID-19 cases in resource-poor African settings may differ from other settings where data are available.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COVID-19 risk factors COVID-19 outcomes Africa South Sudan Democratic Republic of the Congo Humanitarian

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Suspected and Confirmed COVID-19 cases

Suspected and confirmed COVID-19 cases (age 5 years and above) identified at health facilities or via mobile teams in Juba, South Sudan and in Eastern Democratic Republic of the Congo.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suspected, probable, and confirmed COVID-19 cases presenting for care at participating health facilities (either by walk-in, referral or transfer) or identified by mobile contact tracing teams.

Exclusion Criteria

* Individuals unable or unwilling to give informed consent (e.g., due to mental impairment)
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Medical Corps

UNKNOWN

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shannon Doocy, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Goma General Hospital

Goma, , Democratic Republic of the Congo

Site Status

Bukavu General Hospital

Kinshasa, , Democratic Republic of the Congo

Site Status

Dr John Garang Infectious Diseases Unit

Juba, , South Sudan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Democratic Republic of the Congo South Sudan

References

Explore related publications, articles, or registry entries linked to this study.

Leidman E, Doocy S, Heymsfield G, Sebushishe A, Mbong EN, Majer J; IMC-CDC COVID-19 Research Team; Bollemeijer I. Risk factors for hospitalisation and death from COVID-19: a prospective cohort study in South Sudan and Eastern Democratic Republic of the Congo. BMJ Open. 2022 May 18;12(5):e060639. doi: 10.1136/bmjopen-2021-060639.

Reference Type DERIVED
PMID: 35584876 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13736

Identifier Type: -

Identifier Source: org_study_id