The novel coronavirus commonly known as SARS-CoV-2 (Severe acute respiratory syndrome coronavirus-2), is the cause of a highly contagious disease which we have all come to know as coronavirus disease 2019 (COVID-19). The virus was first reported from Wuhan city in China in December 2019, and in less than three months spread throughout the globe and was declared a global pandemic by the World Health Organisation (WHO) on 11^th March,2020.

Researchers around the world are working at record speed to find the best ways to prevent control and manageCOVID-19 patients by investigating the possibility of repurposing existing drugs and vaccines to searching for novel therapies and vaccines against the virus.

The Centre for Infectious Disease Research in Zambia (CIDRZ), in collaboration with the Ministry of health and various partners and donors (local and international) has been undertaking a number of research studies around COVID-19.

Among the studies CIDRZ is undertaking are (i) observational studies (i.e. Active COVID-19 Cases (CoVPN 5001), a study on COVID-19 Recovered Cases (HVTN 405/HTPN 1901) and a serological study (CoV-Imm) to explore the exposure to SARS-CoV-2 and other human corona viruses that are endemic in Zambia.

What is the CoVPN 5001 study about?

This is an active study being run by the COVID-19 Prevention Network (CoVPN) across 58 participating trial sites in the United States, South America and Sub-Saharan Africa. Countries participating in the study under sub-Saharan Africa include South Africa, Botswana, Kenya, Mozambique, Malawi, Tanzania, Zambia and Zimbabwe.  The entire study seeks to enrol approximately 800 participants with CIDRZ study seeking to enrol a maximum 50 participants and a minimum of 10 participants.

The purpose of this study is to understand early SARS-CoV-2 infection and the body’s early immune responses to the virus for scientists to be able to come up with an effective therapy or a vaccine against COVID-19.

To enrol in the study, under the Zambian arm, one needs to be a Lusaka resident, aged 18 years or older and has tested positive for SARS-CoV- 2 infection. The study duration for each participant is two months. During this period there are seven study visits, six study visits spread over one month and the final study visit, to check on the health of the study participant will be conducted in the second month of the study.  All seven study visits are conducted at the study trial site, located at the CIDRZ Campus office in Ibex Hill Lusaka.

Samples collected from participants include blood samples, nasal samples, saliva samples, urine and stool samples, however, collection of stool samples is optional.

The benefits of this study include:

1. The Study will enable the participants know whether or not their immune system has developed anti-bodies for SARS-CoV- 2
2. CoVPN 5001 is designated to develop the clinical and laboratory pipelines for the rapid implementation of COVID vaccine efficacy trials while conducting ground-breaking scientific investigations.
3. The data obtained through this study will be used to come up with a preventive therapy for COVID.

This study is on-going and will only be closed once CIDRZ reaches its maximum target of enrolment.

What is HVTN 405/HPTN 1901 study about?

HVTN 405/HPTN 1901 study is meant to describe immune responses in study participants with a history of recovering from SARS- CoV-2 infection.  This Study is sponsored by the HIV Vaccine Trials Network and the HIV Prevention Network (HPTN). The main aim of HVTN 405/HPTN 1901 is to develop antibody assays that can be reliably used to detect SARS-CoV-2 infection in vaccine and monoclonal antibody studies to prevent COVID-19. This information will be critical in illuminating the path to the development and testing of safe and effective vaccine and antibody interventions to prevent COVID-19.

The study seeks to enrol 85 participants.  To enrol for the study, one should be 18 years of age or older, should not be pregnant and should not be positive for SARs- Cov-2 but should have recovered from SARS-Cov -2 between 2 to 10 weeks prior to the day of enrolment.

Individuals who have not fully recovered from their infection (i.e., still have symptoms or had a positive test within the preceding two weeks) will not be enrolled. Participants will attend one required clinic visit and will have the option to attend additional clinic visits two, four and twelve months after the initial visit. Each visit includes a questionnaire, blood draw and optional nasal sampling.

The benefits of the study include:

1. This study will describe the body’s natural immune responses to SARS-CoV-2, thus illuminating the path to the development and testing of a safe and effective vaccine.
2. Vaccines will not only be essential to prevent new infections and reduce morbidity and mortality, but they will also aid in a return to a thriving social and economic global infrastructure.

What is CoV-Imm Study about?

Pre and post pandemic assessment of coronavirus immunity and cross-protection against SARS-CoV-2 in mother-infant pairs and adult healthcare workers in Zambia (CoV-Imm) is a study to determine exposure to circulating CoV strains and SARS-CoV-2 pre- and post-the ongoing pandemic in children (Lusaka) and adults including high risk health care workers (HCW) (Kalulushi, Copperbelt.

The main goal of this study is to understand whether children and adults within the general population and HCW have pre-existing immunity to non-pandemic HCoV and investigate cross-protective immunity to SARS-CoV-2.

The study intends to address a critical COVID-19 disease related knowledge gap by assessing the degree of pre-existing immunity to other human corona viruses (hCoV) and investigating cross-reactiveness to SARS-CoV-2 in Zambian infants and adults including HCW. This knowledge will be critical to future management of SARS-CoV-2 infection in the target populations and to understanding the potential impacts of future interventions against SARS-CoV-2 and indeed other emerging CoVs in the Zambian population including how these could modify existing natural immunity to seasonal hCoV.

The benefits of the study include:

It is anticipated that this research will provide important information which will inform strategy in public health and wider community settings:

1. Information on the exposure of HCW to hCoV and SARS-CoV-2 will inform future mitigation strategies in higher risk healthcare settings
2. Preliminary estimates of exposure by seroprevalence to hCoV and SARS-CoV-2 in children and adults in the wider Zambian population in relation to current SARS-CoV-2 disease prevalence estimates to inform treatment resource allocation.
3. An immediate contribution towards the technical expertise and skills base for serological and cellular monitoring of cumulative hCoV and SARS-CoV-2 exposure in Zambia.

PHOTO FOCUS – CIDRZ ADDITIONAL MATERO CLINICAL RESEARCH SITE LOCATED AT CHAINDA SOUTH CLINIC