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EpidemiologyNCT04584424

Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia

An observational study of Epidemiology and Clinical, run by Ethiopian Public Health Institute at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Epidemiology, Clinical, Nutritional-status
What is being tested?
The study does not required
How many people
6,390 participants
Where
1 siteEthiopia
Study dates
30 Oct 2020to 14 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Saro Abdella

    Addis Ababa, 1242

Other trials in Ethiopia

About this study

Official title: 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.

Read the 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.

Being tested
The study does not required
Keywords
Ethiopia, Epidemiological and Clinical features of COVID-19 cases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The study does not requiredOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients survival or death

    Number patients developing severe infection or death

    Measured: 12 months

  2. Rate of recovery time

    Mean rate of recovery in patients with diagnosis of COVID-19

    Measured: 4 weeks

  3. Viral shedding

    proportion of shedding detected in environment and personal protective equipment

    Measured: 6 weeks

Secondary outcomes (8)

  1. Viral loads

    quantity of viral load

    Measured: 12 months

  2. Clinical symptoms and signs

    clinical manifestations Proportions of mild, moderate, severe and critical cases

    Measured: 12 months

  3. 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.

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

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

    proportion of patients with cancer and COVID-19 postive

    Measured: 4 weeks

  6. Lipid Profiles

    TC, TG, HDL-C, and LDL-C

    Measured: 12 months

  7. Assess the prevalence of nutrient intakes

    Prevalence of inadequate intake of zinc, Iron and Vitamin A

    Measured: 12 months

  8. Assess the prevalence of micronutrients deficiencies among hospitalized patients with COVID-19

    Prevalence of Vitamin D, zinc, and Iron deficiency anemia measured in serum

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start30 Oct 2020
  3. Primary completion14 Nov 2022
  4. Study completion14 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584424
Sponsor's protocol ID
EPHI National Cohort
Status last verified
Sep 2024
First submitted
22 Sep 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The di-identified datasets after reaching objectives of the study could shared. Interested researchers can request investigators.

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.

    PubMed 34530744

Questions about this trial

What is this clinical trial studying?

An observational study of Epidemiology and Clinical, run by Ethiopian Public Health Institute at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients survival or death (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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