Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ethiopian Public Health Institute | OTHER_GOV |
| Liverpool School of Tropical Medicine | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without parasite | For secondary outcome: effect of co-infection with parasite on COVID-19 severity Group 1 will constitute those without parasite co-infection | ||
| With parasite | For secondary outcome: effect of co-infection with parasite on COVID-19 severity Group 2 will constitute those with parasite co-infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intestinal parasite | Other | Pre-existing intestinal parasite infection present or absent at time of admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients identified as Covid-19 by and monitoring virus clearance with COVID-19 using algorithm of RDTs. | RT-PCR confirmed Covid-19 patients identified by rapid antibody- and antigen-based assays | Up to 30 days after onset of infection |
| Proportion of non-Covid-19 cases identified as negative by antibody assay | Healthy controls on samples collected pre-Covid-19 pandemic period tested by rapid antibody-based assays | Up to 30 days after onset of infection other than SARS-CoV-2 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Ethiopian vs. European COVID-19 patients with predominant Th1 type immune responses. | Different immune biomarkers measured in Covid-19 patients presenting with different disease severity stage/spectrum | Up to 30 days after onset of infection |
| Proportion of severe COVID-19 patients with or without parasite co-infection |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients suspected of having SARS-CoV-2 infection and admitted to Covid-19 isolation and treatment centers.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dawit Wolday, MD, PhD | Mekelle University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mekelle University College of Health Sciences | Mek'ele | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37215303 | Background | Gebrecherkos T, Challa F, Tasew G, Gessesse Z, Kiros Y, Gebreegziabxier A, Abdulkader M, Desta AA, Atsbaha AH, Tollera G, Abrahim S, Urban BC, Schallig H, Rinke de Wit T, Wolday D. Prognostic Value of C-Reactive Protein in SARS-CoV-2 Infection: A Simplified Biomarker of COVID-19 Severity in Northern Ethiopia. Infect Drug Resist. 2023 May 16;16:3019-3028. doi: 10.2147/IDR.S410053. eCollection 2023. | |
| 35320286 |
Not provided
Not provided
Data available upon request and assessment by Ethics Review approvals
Not provided
Open
For secondary data analysis, systematic reviews and meta-analysis
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| Tigray Health Research Institute |
| OTHER |
Not provided
Not provided
Not provided
Plasma samples and PBMC biobanking for further analysis
Stool exam undertaken among COVID-19 patients presenting with different clinical status at time of admission or isolation |
| Up to 45 days after onset of infection/during hospitalization) |
| Proportion of patients with SARS-CoV-2 neutralizing antibody titer | Measurement of neutralizing antibody titers | Up to 45 days of follow-up after symptom onset |
| Result |
| Gebrecherkos T, Kiros YK, Challa F, Abdella S, Gebreegzabher A, Leta D, Desta A, Hailu A, Tasew G, Abdulkader M, Tessema M, Tollera G, Kifle T, Arefaine ZG, Schallig HH, Adams ER, Urban BC, de Wit TFR, Wolday D. Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub-Saharan Africa: A prospective longitudinal study. PLoS One. 2022 Mar 23;17(3):e0263627. doi: 10.1371/journal.pone.0263627. eCollection 2022. |
| 34368662 | Result | Wolday D, Gebrecherkos T, Arefaine ZG, Kiros YK, Gebreegzabher A, Tasew G, Abdulkader M, Abraha HE, Desta AA, Hailu A, Tollera G, Abdella S, Tesema M, Abate E, Endarge KL, Hundie TG, Miteku FK, Urban BC, Schallig HHDF, Harris VC, de Wit TFR. Effect of co-infection with intestinal parasites on COVID-19 severity: A prospective observational cohort study. EClinicalMedicine. 2021 Sep;39:101054. doi: 10.1016/j.eclinm.2021.101054. Epub 2021 Jul 31. |
| 33935986 | Result | Wolday D, Tasew G, Amogne W, Urban B, Schallig HD, Harris V, Rinke de Wit TF. Interrogating the Impact of Intestinal Parasite-Microbiome on Pathogenesis of COVID-19 in Sub-Saharan Africa. Front Microbiol. 2021 Apr 16;12:614522. doi: 10.3389/fmicb.2021.614522. eCollection 2021. No abstract available. |
| 33741488 | Result | Abraha HE, Gessesse Z, Gebrecherkos T, Kebede Y, Weldegiargis AW, Tequare MH, Welderufael AL, Zenebe D, Gebremariam AG, Dawit TC, Gebremedhin DW, de Wit TR, Wolday D. Clinical features and risk factors associated with morbidity and mortality among patients with COVID-19 in northern Ethiopia. Int J Infect Dis. 2021 Apr;105:776-783. doi: 10.1016/j.ijid.2021.03.037. Epub 2021 Mar 16. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |