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

NCT04473365 | Completed

• 1 other identifier: RIA2020EF-2905
• Study Type: observational
• Target: 838
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV-2; COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (3)

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

  Up to 30 days after onset of infection

• Proportion of severe COVID-19 patients with or without parasite co-infection

  Up to 45 days after onset of infection/during hospitalization)

• Proportion of patients with SARS-CoV-2 neutralizing antibody titer

  Up to 45 days of follow-up after symptom onset

Study Arms (2)

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

Other: Intestinal parasite

Interventions

Intestinal parasite OTHER

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

Also known as: Without intestinal parasite

With parasite

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of having SARS-CoV-2 infection and admitted to Covid-19 isolation and treatment centers.

You may qualify if:

• Clinical case-definition confirmed by RT-PCR.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mekelle University: lead
• Ethiopian Public Health Institute: collaborator
• Liverpool School of Tropical Medicine: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Tigray Health Research Institute: collaborator

Study Sites (1)

Mekelle University College of Health Sciences

Mek'ele, Ethiopia

Location

Related Publications (5)

• 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.

  PMID: 37215303 BACKGROUND

• 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.

  PMID: 35320286 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.

  PMID: 34368662 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.

  PMID: 33935986 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.

  PMID: 33741488 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples and PBMC biobanking for further analysis

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dawit Wolday, MD, PhD

  Mekelle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 16, 2020
• Study Start: July 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Open
• Access Criteria: For secondary data analysis, systematic reviews and meta-analysis

Locations

ET (1)