Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia

Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia: Multi-Site Cohort Study

The aim of the study will be to determine the epidemiological and clinical features of COVID-19 cases, immunological and virological courses, interaction with nutritional status, and response to treatment for COVID-19 patients admitted to treatment centers in Ethiopia.

Methods: This multi-site cohort enrolls, patients with confirmed COVID-19 infection admitted to treatment centers will be enrolled irrespective of their symptoms and followed up for 12 months. Baseline epidemiological, clinical, laboratory and imaging data will be collected from treatment records, interviews, physical measurements and biological samples. Endline data involves treatment and prognostic outcomes to be measured using different biomarkers and clinical parameters, The patients will be followed up in the selected treatment centers for COVID-19 infection. For all data collected both descriptive and multivariable analyses will be performed to isolated determinants of the treatment outcome and prognosis to generate relevant information for informed prevention and case management.

Study Overview

• Status: Unknown
• Conditions: Clinical; Epidemiology; Nutritional-status; Immunologic Defect
• Intervention / Treatment: Other: The study does not required

Detailed Description

Background: The coronavirus disease 2019 (COVID-19) became pandemic after emerging in Wuhan, China, in December 2019 which is caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2). Following the swift spread of the virus,4, 710,000 confirmed cases and 315,000 deaths were reported worldwide as of May 17, 2020,and 317 confirmed cases and 5 deaths are reported nationally. To understand the drastically negative impacts of COVID-19 on the public health and key features pertinent to the disease various researches are under investigation at the global level and they are contributing to delineating the characteristics of the disease and its lethality. However, the potential acceptability of different risks varies depending on numerous factors including the type of research and the context in which it takes place. Currently, it is recognized that a 'one size fits all' approach towards the design and implementation of interventions may not be appropriate. Therefore, it is found apparent that global priorities, protocols and intervention assessments have to be contextualized and adjusted to local needs and realities, including translation of results.

Objective: To determine the epidemiological and clinical features of COVID-19 cases, immunological and virological courses, interaction with nutritional status, and response to treatment for COVID-19 patients admitted to treatment centers in Ethiopia.

Methods: This multi-site cohort enrolls, patients with confirmed COVID-19 infection admitted to treatment centers will be enrolled irrespective of their symptoms and followed up for 12 months. Baseline epidemiological, clinical, laboratory and imaging data will be collected from treatment records, interviews, physical measurements and biological samples. Endline data involves treatment and prognostic outcomes to be measured using different biomarkers and clinical parameters, The patients will be followed up in the selected treatment centers for COVID-19 infection. For all data collected both descriptive and multivariable analyses will be performed to isolated determinants of the treatment outcome and prognosis to generate relevant information for informed prevention and case management.

Expected outcome: The study will generate scientific data for a systematic understanding of natural history, epidemiological characteristics, clinical features and management of COVID-19 that will in turn enables country's health sector to develop strategies to prevent and control the pandemic before it poses further health and socioeconomic crisis.

• Study Type: Observational
• Enrollment (Anticipated): 6390

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia, 1242
    • Saro Abdella
    • Contact: Saro Abdella, MPhil; Phone Number: +251913379751; Email: helen_saro@yahoo.com
    • Contact: Masresha Tessema; Phone Number: +251919782082; Email: masresha88@gmail.com
    • Principal Investigator: Saro Abdella, mPhil
    • Principal Investigator: Masresha Tessema, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will be confirmed SARS-CoV-2 infection (virologically confirmed diagnosis by RT-PCR). This will include both symptomatic (sever, moderate and critical cases) and asymptomatic patients.

Description

Inclusion Criteria:

• Patient admitted to treatment centers, with confirmed SARS-CoV-2 infection (virologically confirmed diagnosis by RT-PCR).
• Agrees to be enrolled in the follow-up study and provide all necessary information/data, blood and nasopharyngeal swab for testing.

Exclusion Criteria:

• A subject deprived of freedom, subject under a legal protective measure
• Refusal by participant, parent or appropriate guardian or representative
• Confirmed diagnosis of other pathogens unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen.
• Participants who will not willing to stay 12 months in the cohort in Ethiopia.
• Those who are prior involved in the COVID-19 clinical trial or other intervention studies.
• Not capable of understanding or complying with the study protocol or provide consent
• Anticipated transfer to another hospital that is not a study site within 72 hours
• Patients who cannot stand straight due to amputation, kyphosis, scoliosis or paralyzes.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients survival or death	Number patients developing severe infection or death	12 months
Rate of recovery time	Mean rate of recovery in patients with diagnosis of COVID-19	4 weeks
Viral shedding	proportion of shedding detected in environment and personal protective equipment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral loads	quantity of viral load	12 months
Clinical symptoms and signs	clinical manifestations Proportions of mild, moderate, severe and critical cases	12 months
Blood pressure	Force exerted by the blood against the walls of the vessels (arteries) as it is pumped by the heart. Measurement using the multi-parameter vital signs monitor. Units of measurement in mmHg. Obtain systolic and diastolic pressure.	4 weeks
Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19	Prevalence of severe forms among all COVID-19 patients with diabetes	4 weeks
Assess the prevalence of severe forms among hospitalized patients with cancer and COVID-19	proportion of patients with cancer and COVID-19 postive	4 weeks
Lipid Profiles	TC, TG, HDL-C, and LDL-C	12 months
Assess the prevalence of nutrient intakes	Prevalence of inadequate intake of zinc, Iron and Vitamin A	12 months
Assess the prevalence of micronutrients deficiencies among hospitalized patients with COVID-19	Prevalence of Vitamin D, zinc, and Iron deficiency anemia measured in serum	12 months

Collaborators and Investigators

• Sponsor: Ethiopian Public Health Institute
• Collaborators: Netherlands: Ministry of Health, Welfare and Sports

Publications and helpful links

General Publications

• Abdella S, Tessema M, Tasew G, Defar A, Deressa A, Regasa F, Teka F, Tigabu E, Nigussie D, Belachew T, Molla M, Deribew A, Abebe W, Yigzaw T, Nigatu T, Mitike G, Haile T, Taame H, Ahmed M, Nigatu F, Tolesa T, Wolka E, Amogne W, Laillou A, Amare M, Fufa Y, Argaw A, Waganew W, Azazh A, Worku A, Redae B, Sultan M, Walelegn M, Tefera M, Yifru S, Argaw R, Brehau N, Teklu S, Demoz G, Seman Y, Salasibew M, Ejeta E, Whiting SJ, Wolday D, Tollera G, Abate E, Duguma D. Prognostic factors and outcomes of COVID-19 cases in Ethiopia: multi-center cohort study protocol. BMC Infect Dis. 2021 Sep 16;21(1):956. doi: 10.1186/s12879-021-06652-0.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2020
• Primary Completion (Anticipated): September 14, 2021
• Study Completion (Anticipated): November 14, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Ethiopia, Epidemiological and Clinical features of COVID-19 cases
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EPHI National Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The di-identified datasets after reaching objectives of the study could shared. Interested researchers can request investigators.
• IPD Sharing Time Frame: The data will be available upon compilation of the data collection and cleaning
• IPD Sharing Access Criteria: This may depend on the request and objectives.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No