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

December 14, 2023 updated by: Prof. Dawit Wolday, Mekelle University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

838

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dawit Wolday, MD, PhD
  • Phone Number: +251-911-208984
  • Email: dawwol@gmail.com

Study Contact Backup

Study Locations

  • Ethiopia
      • Mekelle, Ethiopia
        • Mekelle University College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Pre-existing intestinal parasite infection present or absent at time of admission
Other Names:
  • Without intestinal parasite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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
Up to 30 days after onset of infection other than SARS-CoV-2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 days after onset of infection
Proportion of severe COVID-19 patients with or without parasite co-infection
Time Frame: Up 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
Up to 45 days after onset of infection/during hospitalization)
Proportion of patients with SARS-CoV-2 neutralizing antibody titer
Time Frame: Up to 45 days of follow-up after symptom onset
Measurement of neutralizing antibody titers
Up to 45 days of follow-up after symptom onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mekelle University

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Liverpool School of Tropical Medicine
Ethiopian Public Health Institute
Tigray Health Research Institute

Investigators

  • Principal Investigator: Dawit Wolday, MD, PhD, Mekelle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 11, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIA2020EF-2905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available upon request and assessment by Ethics Review approvals

IPD Sharing Time Frame

Open

IPD Sharing Access Criteria

For secondary data analysis, systematic reviews and meta-analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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