Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

African Covid-19 Critical Care Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04367207
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
University of KwaZulu
Information provided by (Responsible Party):
Bruce Biccard, University of Cape Town

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).

Condition or disease
Severe Acute Respiratory Syndrome Coronavirus 2

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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
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.
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Bruce M Biccard +27214045015 bruce.biccard@uct.ac.za

Locations
Layout table for location information
South Africa
Groote Schuur Hospital Recruiting
Cape Town, Western Cape, South Africa, 7599
Contact: Margot Flint, PhD    +2721 4045001    margot.flint@uct.ac.za   
Sponsors and Collaborators
University of Cape Town
University of KwaZulu
Investigators
Layout table for investigator information
Principal Investigator: Bruce Biccard University of Cape Town
  Study Documents (Full-Text)

Documents provided by Bruce Biccard, University of Cape Town:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bruce Biccard, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT04367207    
Other Study ID Numbers: ACCCOS
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruce Biccard, University of Cape Town:
Critical Care, Public Health
Additional relevant MeSH terms:
Layout table for MeSH terms
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases