Clinical trial NCT04568499: Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings
Official title: Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings: a Prospective Cohort Study in South Sudan and DRC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19 risk factors
COVID-19 outcomes
Africa
South Sudan
Democratic Republic of the Congo
Humanitarian
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: International Medical Corps
name: Centers for Disease Control and Prevention
First posted: 2020-09-29
Enrollment: 592
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Hospitalization
timeFrame: patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
measure: Mortality
timeFrame: patients will be followed until asymptomatic or deceased (an average of approximately 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Goma
country: Congo, The Democratic Republic of the
facility: Goma General Hospital
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Bukavu General Hospital
city: Juba
country: South Sudan
facility: Dr John Garang Infectious Diseases Unit
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Shannon Doocy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leidman E, Doocy S, Heymsfield G, Sebushishe A, Mbong EN, Majer J; IMC-CDC COVID-19 Research Team; Bollemeijer I. Risk factors for hospitalisation and death from COVID-19: a prospective cohort study in South Sudan and Eastern Democratic Republic of the Congo. BMJ Open. 2022 May 18;12(5):e060639. doi: 10.1136/bmjopen-2021-060639.