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NCT04568499 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04568499
Other study ID # 13736
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 27, 2020
Est. completion date September 30, 2021

Study information
Verified date November 2021
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 592
Est. completion date September 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Congo, The Democratic Republic of the Goma General Hospital Goma
Congo, The Democratic Republic of the Bukavu General Hospital Kinshasa
South Sudan Dr John Garang Infectious Diseases Unit Juba

Sponsors (3)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Centers for Disease Control and Prevention, International Medical Corps

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  South Sudan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization 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)
Primary Mortality 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)
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