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

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.

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.

Unknown status
Epidemiology
Clinical
Nutritional-status
Immunologic Defect

Other: The study does not required

The study is prospective multi-center COVID-19 patient cohort

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Ethiopia
Locations

Saro Abdella
Addis Ababa, Ethiopia

Investigator: Saro Abdella, MPhil
Contact: +251913379751
helen_saro@yahoo.com

Investigator:

Netherlands: Ministry of Health, Welfare and Sports
NCT Number
Keywords
Ethiopia, Epidemiological and Clinical features of COVID-19 cases
MeSH Terms
COVID-19