Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia

NCT04584424 | Completed

• 1 other identifier: EPHI National Cohort
• Study Type: observational
• Target: 6,390
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidemiology; Clinical; Nutritional-status; Immunologic Defect

Keywords

Ethiopia, Epidemiological and Clinical features of COVID-19 cases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Viral loads

  12 months

• Clinical symptoms and signs

  12 months

• Blood pressure

  4 weeks

• Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19

  4 weeks

• Assess the prevalence of severe forms among hospitalized patients with cancer and COVID-19

  4 weeks

Interventions

The study does not required OTHER

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethiopian Public Health Institute: lead

Study Sites (1)

Saro Abdella

Addis Ababa, 1242, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 34530744 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

i. Laboratory diagnosis of SARS-CoV-2 infection: Patients' nasopharyngeal/through swab specimens will be collected for the SARS-CoV-2 viral nucleic acid detection using real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. ii. Phylogenetic analysis of SARS-CoV-2. iii. Imaging: Chest x-ray, chest computed tomographic (CT) scans data will be retrieved if available. iv. Clinical chemistry: Albumin, Fibrinogen level, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine, cardiac troponin, D-Dimer, pro-calcitonin and C-reactive protein, and vitamin D concentration will be assessed using fully automated Cobas 6000. v. Serum levels of Anti-SARS-CoV-2 IgM, IgG or IgM/IgG antibodies, selected pro-inflammatory cytokines, anti-inflammatory or regulatory cytokines and chemokines will be measured using rapid or ELISA based platforms.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 14, 2020
• Study Start: October 30, 2020
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available upon compilation of the data collection and cleaning
• Access Criteria: This may depend on the request and objectives.

Locations

ET (1)