Research Article

Coronavirus Host Genomics Study: South Africa (COVIGen-SA)

Table 1

A brief overview of COVIGen-SA partner studies.

PartnerProject namesDescription of projectParticipant inclusion criteriaCatchment areaSelf-identified ethnicityTarget sample size

AADOREA single-arm, phase 3, pilot study investigating the efficacy of doravirine in adults living with HIV experiencing virological failure on first-line EFV-based ART with NNRTI resistance.PLHIV, 18 years or older with confirmed first generation NNRTI resistance on first-line EFV-based ART.Clinics and hospitals, Johannesburg, Gauteng province (urban)Black African25
ADVANCEA randomised, phase 3 non-inferiority study of DTG + TAF + FTC compared with DTG + TDF + FTC and EFV + TDF + FTC in patients infected with HIV-1 starting first-line ART.PLHIV, ART-naïve, 12 years and older.Clinics and hospitals, Johannesburg, Gauteng province (urban)Black African1,053
COVERA multicentre, randomised, open-label study of NTZ or SOF/DCV, compared to no pharmacological intervention for the prevention of COVID-19 disease in healthcare workers and inner city inhabitants at high risk of exposure to SARS-CoV-2.People of 18 years and older at high risk of exposure to SARS-CoV-2, no existing symptoms of COVID-19, not vaccinated against COVID, emale participants—no intention to fall pregnant.Clinics and hospitals, Johannesburg, Gauteng province (urban)Black African1,950
(25% enrolled)
DORAA single-arm, phase 3, pilot switch study, exploring the safety of doravirine-based first-line ART for women of reproductive potential living with HIV.Females living with HIV, between 18 and 49 years old, on reliable contraception or not intending to fall pregnant, on first-line ART comprising EFV/TDF/FTC or DTG/TDF/3TC.Clinics and hospitals, Johannesburg, Gauteng province (urban)Black African100
DUACTA randomised double-blinded study to assess the antiviral efficacy, safety, and tolerability of dual combination antiviral coronavirus therapy (ribavirin and NTZ) in ambulatory participants diagnosed with acute COVID-19.People between 18 and 75 years old, diagnosed with SARS-CoV-2 infection, with at least one constitutional symptom (but not critically ill), with onset within 72 hours.Clinics and hospitals, Johannesburg, Gauteng province (urban)Black African52 (65% enrolled)

BHealthcare WorkersA study investigating the epidemiology of SARS-CoV-2 infection among healthcare workers from Chris Hani Baragwanath Academic Hospital.Any healthcare worker from Chris Hani Baragwanath Hospital. All participants were enrolled in COVIGen-SA.Soweto, Johannesburg, Gauteng province (urban)Not specified400
Hospital surveillanceA study describing the burden and clinical characteristics of COVID-19-associated hospitalisations.People of 18 years or older admitted to Chris Hani Baragwanath Hospital with a confirmed SARS-CoV-2 infection.Soweto, Johannesburg, Gauteng province (urban)Not specified10,000
Pregnant womenA study evaluating the association of SARS-CoV-2 infection during pregnancy and poor fetal outcomes.Pregnant women or women in labour who are of 18 years or older attending Chris Hani Baragwanath Academic Hospital or Rahima Moosa Mother and child hospital with confirmed SARS-CoV-2 infection.Soweto and Coronationville, Johannesburg, Gauteng province (urban)Not specified3,000

CPHIRST-CA prospective household study of SARS-CoV-2, influenza, and RSV community burden, transmission dynamics, and viral interaction in South Africa.3 or more individuals living in a household, all willing to consent and be available for twice weekly testing.SA/MRC wits Agincourt health and demographic surveillance system site, Bushbuckridge, Mpumalanga province (rural); Jouberton, Klerksdorp, north-west province (urban)Majority Black African600 at each site
National surveillanceA prospective active surveillance programme for respiratory illness, including testing for SARS-CoV-2, influenza, RSV, and pertussis.People of all ages fulfilling the clinical case definition of a severe respiratory illness.Helen Joseph and Rahima Moosa Mother and child hospital, Johannesburg, Gauteng province (urban)Any400 per month for the duration of surveillance

DPot prevA surveillance and observational study looking at the incidence of physician-diagnosed, community-acquired pneumonia in three provinces in South Africa.People of 18 years and older with clinical and radiologically confirmed community-acquired pneumonia.Soweto, Johannesburg, Gauteng province; Klerksdorp, North West province; Polokwane, Limpopo province (all sites are urban)Black African, White, mixed ancestrySoweto: 900
Klerksdorp: 900
Polokwane: 200
EAHRIA node of the South African population infrastructure network (SAPRIN) that supports four surveillance sites in South Africa. Vukuzazi is a population multiomics cohort within the AHRI node of SAPRIN that aimed to measure the prevalence and overlap of four diseases (HIV, TB, hypertension, and diabetes) in an HIV endemic population and collect biosamples to support research into the social, environmental, and biological drivers of health and disease.SAPRIN: All household members resident within the boundaries of the respective surveillance areas (140,000 individuals). Vukuzazi: 18,000 individuals aged 15 and older—consented to genomic analysis of stored blood samples. Participants are screened for SARS-CoV-2, with positive cases enrolled in COVIGen-SA.Northern KZN (rural), Agincourt Mpumalanga (rural)Black AfricanSAPRIN: 140,000
Vukukazi cohort: 18,000

FGIVOCAA longitudinal observational study of adult SARS-CoV-2 RT-PCR confirmed hospitalised adults.People hospitalised with SARS-CoV-2 infection, 18 years or older, with or without HIV.Soweto and surrounding areas, Gauteng province (urban)Black African200

A: ezintsha, B: vaccines and infectious diseases analytics research unit, C: centre for respiratory diseases and meningitis and the MRC/wits rural public health and health transitions research unit [40], D: Perinatal HIV Research Unit, E: African health research institute (AHRI) [41, 42], F: HIV vaccine translational research entity, 3TC: lamivudine, ART: antiretroviral treatment, DCV: daclatasvir, DTG: dolutegravir, EFV: efavirenz, FTC: emtricitabine, HIV: human immunodeficiency virus, NNRTI: non-nucleoside reverse transcriptase inhibitor, NTZ: nitazoxanide, PLHIV: people living with HIV, RSV: respiratory syncytial virus, SOF: sofosbuvir, TAF: tenofovir alafenamide, and TDF: tenofovir disoproxil.