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

Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings: a Prospective Cohort Study in South Sudan and DRC

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Goma, Congo, The Democratic Republic of the
        • Goma General Hospital
      • Kinshasa, Congo, The Democratic Republic of the
        • Bukavu General Hospital
      • Juba, South Sudan
        • Dr John Garang Infectious Diseases Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults and children >=5 years of age residing in catchment areas of participating health facilities and mobile contact tracing teams in Juba, South Sudan and in Eastern Democratic Republic of the Congo.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
Hospitalization due to COVID-19 (proportion of participants hospitalized and risk factors for hospitalization)
patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
Mortality
Time Frame: patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
Death due to COVID-19 (proportion of participants deceased and risk factors for death)
patients will be followed until asymptomatic or deceased (an average of approximately 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shannon Doocy, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A limited de-identified data set will be posted on humanitarian data exchange.

IPD Sharing Time Frame

Upon completion of analysis and publication of the results, the data will be made publicly available.

IPD Sharing Access Criteria

None - data will be accessible via Humanitarian Data Exchange

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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