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

Completed

• Conditions: COVID-19

• Registration Number: NCT04568499
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

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 Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-29
• Study Start: 2020-11-27
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospitalization	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)
Mortality	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)

Trial Locations

Locations (3)

Goma General Hospital; 🇨🇩 Goma, Congo, The Democratic Republic of the

Bukavu General Hospital; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

Dr John Garang Infectious Diseases Unit; 🇸🇸 Juba, South Sudan