- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568499
Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings
November 1, 2021 updated by: Johns Hopkins Bloomberg School of Public Health
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
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Goma, Congo, The Democratic Republic of the
- Goma General Hospital
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Kinshasa, Congo, The Democratic Republic of the
- Bukavu General Hospital
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Juba, South Sudan
- Dr John Garang Infectious Diseases Unit
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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 |
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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.
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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)
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Hospitalization due to COVID-19 (proportion of participants hospitalized and risk factors for hospitalization)
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patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
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Mortality
Time Frame: patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
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Death due to COVID-19 (proportion of participants deceased and risk factors for death)
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patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13736
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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