NCT05268380: Core-NB

Collision of Three Global Pandemics: the Effect of Tuberculosis and HIV on the Epidemiological, Clinical, Virological and Immunological Trajectory of COVID-19 in Botswana and Namibia

Completed Last updated 24 October 2024

What this trial tests

trial testing Covid-19, TB and HIV diagnosis in COVID-19 in 1,750 participants. Completed in 29 February 2024.

Timeline

1 August 2022

Primary endpoint
30 September 2023

29 February 2024

Quick facts

Lead sponsor	University of Namibia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,750
Start date	1 August 2022
Primary completion	30 September 2023
Estimated completion	29 February 2024
Sites	1 location across Namibia

Drugs / interventions tested

• Covid-19, TB and HIV diagnosis

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• HIV Seropositivity — all drugs for HIV Seropositivity →
• Tuberculosis, Pulmonary — all drugs for Tuberculosis, Pulmonary →
• Tuberculosis Infection — all drugs for Tuberculosis Infection →

Sponsor

University of Namibia

Who can join

Eligibility, any sex, with COVID-19 or HIV Seropositivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.