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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568499
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
International Medical Corps
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief Summary:
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.

Condition or disease
COVID-19

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 Design
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Study Type : Observational
Actual Enrollment : 592 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings: a Prospective Cohort Study in South Sudan and DRC
Actual Study Start Date : November 27, 2020
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568499


Locations
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Congo, The Democratic Republic of the
Goma General Hospital
Goma, Congo, The Democratic Republic of the
Bukavu General Hospital
Kinshasa, Congo, The Democratic Republic of the
South Sudan
Dr John Garang Infectious Diseases Unit
Juba, South Sudan
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
International Medical Corps
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Shannon Doocy, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04568499    
Other Study ID Numbers: 13736
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A limited de-identified data set will be posted on humanitarian data exchange.
Time Frame: Upon completion of analysis and publication of the results, the data will be made publicly available.
Access Criteria: None - data will be accessible via Humanitarian Data Exchange
URL: https://data.humdata.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
COVID-19 risk factors
COVID-19 outcomes
Africa
 South Sudan
Democratic Republic of the Congo
Humanitarian
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases