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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05268380
Other study ID # RIA2020EF-2963
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source University of Namibia
Contact Mareli Claassens, PhD
Phone +264814482082
Email mcla@sun.ac.za
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

COVID-19 has emerged as global pandemic during the past few months, with an unprecedented impact on public health, and society more generally. Virus epidemiology is poorly understood, as are factors influencing the diverse clinical picture. To date most cases have been seen in high income countries and consequently COVID-19 diagnostics and research have mainly been set-up in these settings. Outstanding questions include an understanding of how the virus spreads and how it causes pathology. A particular gap in current knowledge is the effect of HIV and tuberculosis (TB) on the outcomes of COVID-19 disease as these two conditions impair the host immune response to other infectious disease. Understanding how these three pandemics interact is crucial. We have developed a proposal that will answer critical questions concerning COVID-19 disease epidemiology in the context of low resource countries with high burden of poverty, and in the presence of high rates of TB and HIV, namely, Namibia and Botswana. Given that there are currently few cases of COVID-19 diagnosed in both countries, the project will document how the virus spreads within susceptible populations. The development of this proposal is highly collaborative and interdisciplinary, with investigators from Namibia and Botswana working closely with colleagues in Europe. We will also work with an NGO in Namibia, Health Poverty Action, to support rapid implementation. The project includes two studies that will be conducted sequentially. The first study will follow the WHO protocol for household transmission investigations in the context of COVID-19. It will explore transmission frequency and describe the clinical spectrum of disease. Samples collected will also serve as basis for COVID-19 molecular epidemiology and host immunological response. The second study will evaluate the presentation, diagnosis and clinical characteristics of individuals presenting to sentinel health facilities in both countries. The project will have a strong laboratory strengthening component which will enhance COVID-19 laboratory and research capacity. This will include the development of skills and knowledge for diagnostic testing and COVID-19 sequencing and will build scientific and research capacity. The findings from this project will provide robust data to assist in guiding national responses to COVID-19 in both countries as well as assisting with our understanding of the pathogenesis of the virus in the context of TB and HIV, in turn providing vital information on how to deliver clinical care and how to design therapeutics and vaccines.


Recruitment information / eligibility

Status Recruiting
Enrollment 2100
Est. completion date December 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Household contact study: all household members of Covid-19 index cases in selected areas - Healthcare facility study: all attendees of selected primary healthcare facilities Exclusion Criteria: - Household contact study: non-household members of Covid-19 index cases in selected areas; individuals not giving consent - Healthcare facility study: individuals not giving consent

Study Design


Intervention

Diagnostic Test:
Covid-19, TB and HIV diagnosis
GeneXpert (sputum) will be used to diagnose active TB disease, IGRA will be used to diagnose latent TB infection, PCR will be used to diagnose Covid-19 active infection, HIV rapid test will be used to diagnose HIV seropositivity.

Locations

Country Name City State
Namibia University of Namibia Windhoek

Sponsors (4)

Lead Sponsor Collaborator
University of Namibia European and Developing Countries Clinical Trials Partnership (EDCTP), Research Center Borstel, Victus Global Botswana Organization

Country where clinical trial is conducted

Namibia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Covid-19 active infection in households To determine Covid-19 active infection amongst household members of Covid-19 index cases 6 months
Primary Covid-19 active infection in healthcare facilities To determine Covid-19 active infection amongst healthcare facility attendees 6 months
Secondary TB infection and disease in households To determine TB infection and disease amongst household members of Covid-19 index cases 6 months
Secondary TB infection and disease in healthcare facilities To determine TB infection and disease amongst healthcare facility attendees 6 months
Secondary HIV seropositivity in households To determine HIV seropositivity amongst household members of Covid-19 index cases 6 months
Secondary HIV seropositivity in healthcare facilities To determine HIV seropositivity amongst healthcare facility attendees 6 months
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