Rapid diagnostic profiling of SARS-CoV-2 (COVID-19) – (Profile-Cov)

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.

Sampling Method:      Non-Probability Sample
Study Population: Patients suspected of having SARS-CoV-2 infection and admitted to Covid-19 isolation and treatment centers.      

Inclusion Criteria:

• Clinical case-definition confirmed by RT-PCR.

Exclusion Criteria:

• Recent history of COVID-19
• Not capable of understanding or complying with the study protocol
• Anticipated transfer to another hospital which is not a study site within 72 hours
• Refusal to consent and participate in the study

Age minimum: N/A
Age maximum: N/A
Gender: All

Outcome Measures:

• Proportion of non-Covid-19 cases identified as negative by antibody assay [Time Frame: Up to 30 days after onset of infection other than SARS-CoV-2]
• Proportion of patients identified as Covid-19 by and monitoring virus clearance with COVID-19 using algorithm of RDTs. [Time Frame: Up to 30 days after onset of infection]

Other Outcome Measures:

• Proportion of Ethiopian vs. European COVID-19 patients with predominant Th1 type immune responses. [ 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

Clinical Trials Registration: NCT04473365

Vaccines (Immune Correlates)

Jul 2020 — Jul 2021

$560,938

Ethiopia

Clinical Epidemiology of COVID-19 in Malaria Settings