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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• COVID-19

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)