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

NCT04568499 | Completed

• 1 other identifier: 13736
• Study Type: observational
• Target: 592
• Locations: 2 countries
• Sites: 3

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.

Conditions

COVID-19

Keywords

COVID-19 risk factors; COVID-19 outcomes; Africa; South Sudan; Democratic Republic of the Congo; Humanitarian

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Individuals unable or unwilling to give informed consent (e.g., due to mental impairment)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• International Medical Corps: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

Goma General Hospital

Goma, Democratic Republic of the Congo

Location

Bukavu General Hospital

Kinshasa, Democratic Republic of the Congo

Location

Dr John Garang Infectious Diseases Unit

Juba, South Sudan

Location

Related Publications (1)

• 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.

  PMID: 35584876 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shannon Doocy, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 29, 2020
• Study Start: November 27, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• 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

Locations

DE (2); SO (1)