Mekelle University College of Health Sciences
Mek'ele, Ethiopia
NCT Number: NCT04473365
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
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Observational
Mek'ele, Ethiopia
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 host's 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-existing intestinal parasite infection present or absent at time of admission
Other names: Without intestinal parasite
Time frame: Up to 30 days after onset of infection
RT-PCR confirmed Covid-19 patients identified by rapid antibody- and antigen-based assays
Time frame: Up to 30 days after onset of infection other than SARS-CoV-2
Healthy controls on samples collected pre-Covid-19 pandemic period tested by rapid antibody-based assays
Time frame: Up to 30 days after onset of infection
Different immune biomarkers measured in Covid-19 patients presenting with different disease severity stage/spectrum
Time frame: Up to 45 days after onset of infection/during hospitalization)
Stool exam undertaken among COVID-19 patients presenting with different clinical status at time of admission or isolation
Time frame: Up to 45 days of follow-up after symptom onset
Measurement of neutralizing antibody titers
Mekelle University
Other
Rapid Diagnostic Profiling of SARS-CoV-2 in the Context of Persistent Immune Activation in Sub-Saharan Africa (Profile-Cov)
Acronym: Profile-Cov
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