Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04473365
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2020-07-11
Brief Title:
Rapid Diagnostic Profiling of SARS-CoV-2 COVID-19
Sponsor:
Mekelle University
Organization:
Mekelle University
Study Overview
Official Title:
Rapid Diagnostic Profiling of SARS-CoV-2 in the Context of Persistent Immune Activation in Sub-Saharan Africa Profile-Cov
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Profile-Cov
Brief Summary:
The investigators will evaluate the profile of the immune response of Ethiopian population and examine its relationship with the noted low CD4 T-cell count and underlying immune activation status among participants with COVID-19 and will compare results with those residing in Europe In addition this project will evaluate the performance of various rapid diagnostic tests RDTs for SARS-CoV-2 taking into account the above-determined immune system characteristics We will also evaluate the effect of co-infection with parasites on COVID-19 severity
Detailed Description:
In December 2019 a cluster of patients with pneumonia of unknown aetiology was linked to an infection with a novel coronavirus - the SARS-CoV-2 Since then the infection has become pandemic and spread affecting almost every country in the world Knowledge of virus dynamics and the hosts immune response to it is essential to understanding the pathogenesis as well as in formulating diagnostic therapeutic and preventive strategies There are no studies however related to these issues particularly in Sub-Saharan Africa SSA context Previous studies by the investigators have shown that the immune profile of healthy Ethiopians shows evidence of chronic immune activation with significant low naïve cells but high activated memory cells of both CD4 and CD8 T-cell sub populations The above immune system characteristics of Ethiopians as compared to Europeans led the investigators to the assumption that these could contribute to the pathogenesis of and severity of clinical presentation of COVID-19 Persistent immune activation due to continuous infections with helminths is common in the entire SSA region Such activation usually skewes the immune system towards T helper Th-2-type responses The immune response against SARS-CoV-2 is typically of so called cytokine storm Here the investigators hypothesize that SARS-CoV-2 infection induced immune activation as observed in patients in the industrialized world with concomitant cytokine storms and extensive non-specific CD8 T-cell cytotoxicity might be more prominent than in people from SSA due to the Th2 profile of their immune system
The investigators propose to study the profile of the immune response of Ethiopian population and will examine its relationship with the noted low CD4 T-cell count and underlying immune activation status among patients with COVID-19 and will compare results with those residing in Europe In addition this project will evaluate the performance of various rapid diagnostic tests RDTs for SARS-CoV-2 taking into account the above-determined immune system characteristics In addition the investigators will evaluate the RDTs for use in the screening of infected patients who are asymptomatic in particular in health-care settings as well as for monitoring recovery or clearance of virus shedding for use in resource-constrained setting Such comparative studies will help identify immune factors that could play a role in attenuating the disrupted immune responses caused by SARS-CoV-2 infection and thus contribute to the design and development of effective diagnostic therapeutic or vaccine
The pathogenesis of severe COVID-19 is related to hyper-inflammation However COVID-19 symptomatology in SSA appears significantly less serious than in industrialized world We postulate that individuals residing in SSA and co-infected with intestinal parasites down regulate immune to SARS-CoV-2 and mute COVID-19 severity
The investigators propose to study the profile of the immune response of Ethiopian population and will examine its relationship with the noted low CD4 T-cell count and underlying immune activation status among patients with COVID-19 and will compare results with those residing in Europe In addition this project will evaluate the performance of various rapid diagnostic tests RDTs for SARS-CoV-2 taking into account the above-determined immune system characteristics In addition the investigators will evaluate the RDTs for use in the screening of infected patients who are asymptomatic in particular in health-care settings as well as for monitoring recovery or clearance of virus shedding for use in resource-constrained setting Such comparative studies will help identify immune factors that could play a role in attenuating the disrupted immune responses caused by SARS-CoV-2 infection and thus contribute to the design and development of effective diagnostic therapeutic or vaccine
The pathogenesis of severe COVID-19 is related to hyper-inflammation However COVID-19 symptomatology in SSA appears significantly less serious than in industrialized world We postulate that individuals residing in SSA and co-infected with intestinal parasites down regulate immune to SARS-CoV-2 and mute COVID-19 severity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None