Rapid Diagnostic Profiling of SARS-CoV-2 (COVID-19)

Completed

• Conditions: SARS-CoV-2; COVID-19
• Interventions: Other: Intestinal parasite

• Registration Number: NCT04473365
• Lead Sponsor: Mekelle University

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 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.

Study Timeline

• Study First Submitted: 2020-07-11
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Study Start: 2020-07-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 838

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With parasite	Intestinal parasite	For secondary outcome: effect of co-infection with parasite on COVID-19 severity Group 2 will constitute those with parasite co-infection

Primary Outcome Measures

Name	Time	Method
Proportion of patients identified as Covid-19 by and monitoring virus clearance with COVID-19 using algorithm of RDTs.	Up to 30 days after onset of infection	RT-PCR confirmed Covid-19 patients identified by rapid antibody- and antigen-based assays
Proportion of non-Covid-19 cases identified as negative by antibody assay	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

Trial Locations

Locations (1)

Mekelle University College of Health Sciences; 🇪🇹 Mekelle, Ethiopia