SARS-CoV-2Profile-CovNCT04473365
Rapid Diagnostic Profiling of SARS-CoV-2 (COVID-19)
An observational study of SARS-CoV-2 and COVID-19, run by Mekelle University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- Intestinal parasite
- How many people
- 838 participants
- Where
- 1 siteEthiopia
- Study dates
- 20 Jul 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients suspected of having SARS-CoV-2 infection and admitted to Covid-19 isolation and treatment centers.
Who may be able to join
- Clinical case-definition confirmed by RT-PCR.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- Intestinal parasite
- Keywords
- Immune profile, Serology, Antibody test, Antigen test, SARS-CoV-2, COVID-19, Immune response, Severity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal parasiteOther
Also called Without intestinal parasite
Pre-existing intestinal parasite infection present or absent at time of admission
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Intestinal parasite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 30 days after onset of infection other than SARS-CoV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start20 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 838 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mekelle University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Liverpool School of Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Tigray Health Research Institute
- Responsible party
- Principal investigator, Prof. Dawit Wolday, Mekelle University
- Investigators
- Dawit Wolday, MD, PhD, Principal investigator, Mekelle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473365
- Sponsor's protocol ID
- RIA2020EF-2905
- Acronym
- Profile-Cov
- Status last verified
- Dec 2023
- First submitted
- 11 Jul 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available upon request and assessment by Ethics Review approvals
Publications
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.
PubMed 37215303Gebrecherkos 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.
PubMed 35320286Wolday 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.
PubMed 34368662Wolday 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.
PubMed 33935986Abraha 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.
PubMed 33741488
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Profiling of SARS-CoV-2 in the Context of Persistent Immune Activation in Sub-Saharan Africa (Profile-Cov)
- ClinicalTrials.gov ID
- NCT04473365
- Acronym / sponsor ID
- Profile-Cov / RIA2020EF-2905
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- Immune profile, Serology, Antibody test, Antigen test, SARS-CoV-2, COVID-19, Immune response, Severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 838 participants (actual)
- Lead sponsor
- Mekelle UniversityUniversity, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Liverpool School of Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Tigray Health Research Institute
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Intestinal parasiteFor secondary outcome: effect of co-infection with parasite on COVID-19 severity Group 2 will constitute those with parasite co-infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of having SARS-CoV-2 infection and admitted to Covid-19 isolation and treatment centers.
Key inclusion criteria (1 listed)
- Clinical case-definition confirmed by RT-PCR.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal parasiteAlso: Without intestinal parasitePre-existing intestinal parasite infection present or absent at time of admission | Other | With parasite |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 37215303Gebrecherkos 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.
- Results publication: PubMed 35320286Gebrecherkos 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.
- Results publication: PubMed 34368662Wolday 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.
- Results publication: PubMed 33935986Wolday 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.
- Results publication: PubMed 33741488Abraha 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.
- Individual participant dataSharing planned: Yes. Data available upon request and assessment by Ethics Review approvals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawit Wolday, MD, PhD principal investigator
Mekelle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by Mekelle University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.