Clinical trial NCT04367207: African Covid-19 Critical Care Outcomes Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Keywords: Critical Care, Public Health
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: University of KwaZulu
First posted: 2020-04-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥18 years) patients referred to intensive care or high-care units in Africa with suspected or known COVID-19 infection in Africa.

Brief summary: 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 that the outcomes will 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 important therefore to establish what resources, comorbidities and interventions are potentially associated with either mortality or survival in patients with COVID-19 who are referred for critical care in Africa. Rapid dissemination of these findings may help mitigate mortality from COVID-19 in critical care patients in Africa. These points provide the rationale for the African COVID-19 Critical Care Outcomes Study (ACCCOS).

Detailed description: 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).

Research questions

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.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients at participating centres referred for high-care unit or intensive care unit admission who have suspected or known COVID-19

Exclusion Criteria:

* None

Primary outcomes:
measure: In-hospital mortality
timeFrame: 8-12 months
Secondary outcomes:
measure: Risk factors (resources, comorbidities and interventions) associated with mortality
timeFrame: 8-12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Bruce Biccard
role: PRINCIPAL_INVESTIGATOR
References:
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citation: African COVID-19 Critical Care Outcomes Study (ACCCOS) Investigators. Patient care and clinical outcomes for patients with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS): a multicentre, prospective, observational cohort study. Lancet. 2021 May 22;397(10288):1885-1894. doi: 10.1016/S0140-6736(21)00441-4.