Clinical trial NCT04584424: Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia
Official title: Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia: Multi-Site Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiology
Clinical
Nutritional-status
Immunologic Defect
Keywords: Ethiopia, Epidemiological and Clinical features of COVID-19 cases
Lead sponsor: Ethiopian Public Health Institute
Sponsor class: OTHER_GOV
First posted: 2020-10-14
Enrollment: 6390
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Number of patients survival or death
timeFrame: 12 months
measure: Rate of recovery time
timeFrame: 4 weeks
measure: Viral shedding
timeFrame: 6 weeks
Secondary outcomes:
measure: Viral loads
timeFrame: 12 months
measure: Clinical symptoms and signs
timeFrame: 12 months
measure: Blood pressure
timeFrame: 4 weeks
measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19
timeFrame: 4 weeks
measure: Assess the prevalence of severe forms among hospitalized patients with cancer and COVID-19
timeFrame: 4 weeks
measure: Lipid Profiles
timeFrame: 12 months
measure: Assess the prevalence of nutrient intakes
timeFrame: 12 months
measure: Assess the prevalence of micronutrients deficiencies among hospitalized patients with COVID-19
timeFrame: 12 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Saro Abdella
Study officials:
References:
citation: 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.