African Covid-19 Critical Care Outcomes Study
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|ClinicalTrials.gov Identifier: NCT04367207|
Recruitment Status : Unknown
Verified September 2020 by Bruce Biccard, University of Cape Town.
Recruitment status was: Recruiting
First Posted : April 29, 2020
Last Update Posted : September 10, 2020
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|Condition or disease|
|Severe Acute Respiratory Syndrome Coronavirus 2|
The infectious disease COVID-19, caused by coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has been declared a pandemic and an international healthcare emergency by the World Health Organization (WHO). It has spread across the globe, overwhelming healthcare systems by causing high rates of critical illness. Mortality from COVID-19 exceeds 4%, with older people with comorbidities being extremely vulnerable.It is expected that between 50-80% of the world's population may contract SARS-CoV-2 over the next two years.
It is expected the outcomes to be potentially worse in Africa, because firstly, there is a limited workforce, and secondly there are limited intensive care facilities and critical care resources across Africa to provide sufficient care. It is estimated that there are 0.8 (95% confidence interval 0.3 to 1.45) critical care beds per 100,000 population in Africa. It is likely that the volume of unplanned admissions associated with COVID-19 will further adversely affect critical care outcomes in Africa,especially as the ability of healthcare systems in Africa to adapt and expand during the pandemic to meet the clinical workload is unknown. Furthermore, the patient outcomes in critical care is poorly documented in this under-resourced environment.
Most countries in Africa are still in the early phase of the epidemic which provides the opportunity to study the utilization of critical care resources and their impact on patient outcomes. It is important therefore to establish what resources, comorbidities and interventions are potentially associated with either mortality or survival in Africa. Rapid dissemination of these findings may help inform appropriate resource prioritisation and utilisation during the COVID-19 pandemic in Africa. These points provide the rationale for the African Covid-19 Critical Care Outcomes Study (ACCCOS).
Primary outcome The primary outcome is in-hospital mortality in adult patients referred to intensive care or high-care units following suspected or known COVID-19 infection in Africa.
Secondary outcomes To determine the risk factors (resources, comorbidities and interventions) associated with mortality in adult patients with suspected or known COVID-19 infection in Africa.
The study is an African national multi-centre prospective observational cohort study of adult (≥18 years) patients referred to intensive care or high-care units in Africa with suspected or known COVID-19 infection in Africa. Patient follow up will be for a maximum of 30 days in-hospital.
This study will run between May to December 2020, with an interim analysis after 250 to 300 deaths registered in the study, or in June or July 2020 if this number of deaths has not been reported in the study. The reason for the interim analysis, is to potentially provide data which may be associated with improved outcomes in Africa, in timeous manner for possible implementation during this COVID-19 pandemic.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||African Covid-19 Critical Care Outcomes Study: An African, Multi-centre Evaluation of Patient Care and Clinical Outcomes for Patients With COVID-19 Admitted to High-care or Intensive Care Units|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Adult patients with COVID-19 referred to intensive care
Prospective observational cohort study of adult (≥18 years) patients referred to intensive care or high-care units in Africa with suspected or known COVID-19 infection in Africa
- In-hospital mortality [ Time Frame: 8-12 months ]The primary outcome is in-hospital mortality in adult patients referred to intensive care or high-care units following suspected or known COVID-19 infection in Africa.
- Risk factors (resources, comorbidities and interventions) associated with mortality [ Time Frame: 8-12 months ]To determine the risk factors (resources, comorbidities and interventions) associated with mortality in adult patients with suspected or known COVID-19 infection in Africa.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- All consecutive patients at participating centres referred for high-care unit or intensive care unit admission who have suspected or known COVID-19
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367207
|Contact: Bruce M Biccardfirstname.lastname@example.org|
|Groote Schuur Hospital||Recruiting|
|Cape Town, Western Cape, South Africa, 7599|
|Contact: Margot Flint, PhD +2721 4045001 email@example.com|
|Principal Investigator:||Bruce Biccard||University of Cape Town|
Documents provided by Bruce Biccard, University of Cape Town:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Bruce Biccard, Professor, University of Cape Town|
|Other Study ID Numbers:||
|First Posted:||April 29, 2020 Key Record Dates|
|Last Update Posted:||September 10, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Critical Care, Public Health
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases