Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia

Epidemiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04584424
• Other study ID #: EPHI National Cohort
• Status: Not yet recruiting
• Start date: October 30, 2020
• Est. completion date: November 14, 2021

Study information

• Verified date: October 2020
• Source: Ethiopian Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6390
• Est. completion date: November 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical
• Epidemiology
• Immunologic Defect
• Nutritional-status

Intervention

Other:
• The study does not required
The study is prospective multi-center COVID-19 patient cohort

Locations

Country	Name	City	State
Ethiopia	Saro Abdella	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
Ethiopian Public Health Institute	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients survival or death	Number patients developing severe infection or death	12 months
Primary	Rate of recovery time	Mean rate of recovery in patients with diagnosis of COVID-19	4 weeks
Primary	Viral shedding	proportion of shedding detected in environment and personal protective equipment	6 weeks
Secondary	Viral loads	quantity of viral load	12 months
Secondary	Clinical symptoms and signs	clinical manifestations Proportions of mild, moderate, severe and critical cases	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Lipid Profiles	TC, TG, HDL-C, and LDL-C	12 months
Secondary	Assess the prevalence of nutrient intakes	Prevalence of inadequate intake of zinc, Iron and Vitamin A	12 months
Secondary	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