Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia (NCT04584424) | Clinical Trial Compass
CompletedNot Applicable
Prognostic Factors and Outcomes of COVID-19 Cases in Ethiopia
Ethiopia6,390 participantsStarted 2020-10-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.