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

Rapid Diagnostic Profiling of SARS-CoV-2 in the Context of Persistent Immune Activation in Sub-Saharan Africa (Profile-Cov)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04473365
Acronym
Profile-Cov
Enrollment
838
Registered
2020-07-16
Start date
2020-07-20
Completion date
2022-06-30
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2

Keywords

Immune profile, Serology, Antibody test, Antigen test, SARS-CoV-2, COVID-19, Immune response, Severity

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.

Interventions

OTHERIntestinal parasite

Pre-existing intestinal parasite infection present or absent at time of admission

Sponsors

Ethiopian Public Health Institute
CollaboratorOTHER_GOV
Liverpool School of Tropical Medicine
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Tigray Health Research Institute
CollaboratorUNKNOWN
Mekelle University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 infectionRT-PCR confirmed Covid-19 patients identified by rapid antibody- and antigen-based assays
Proportion of non-Covid-19 cases identified as negative by antibody assayUp to 30 days after onset of infection other than SARS-CoV-2Healthy controls on samples collected pre-Covid-19 pandemic period tested by rapid antibody-based assays

Other

MeasureTime frameDescription
Proportion of Ethiopian vs. European COVID-19 patients with predominant Th1 type immune responses.Up to 30 days after onset of infectionDifferent immune biomarkers measured in Covid-19 patients presenting with different disease severity stage/spectrum
Proportion of severe COVID-19 patients with or without parasite co-infectionUp 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
Proportion of patients with SARS-CoV-2 neutralizing antibody titerUp to 45 days of follow-up after symptom onsetMeasurement of neutralizing antibody titers

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026