Background
infectious disease, death
INFECTIOUS DISEASE, RECRUITMENT, DISEASE PROGRESSION
Reported as a novel human pathogen in December 2019 in Wuhan, China [The global research community mobilised to address the emergency. Vaccine development had an uncertain timescale and success was far from guaranteed [African countries were thought to be vulnerable to COVID-19, with overcrowding in urban areas, limited access to sanitation and water, fragile health systems, and a high infectious disease burden [In Africa, without a vaccine and limited access to hospital treatment, the urgent need was for affordable COVID-19 drugs that could be given safely in the community at symptom onset to reduce the risk of disease progression, hospitalisation, and death [In response to this urgent need, we conducted a randomised, open-label, phase 2 clinical trial to evaluate the safety and efficacy of four repurposed drug regimens versus standard-of-care (SOC) in outpatients with COVID-19 in Johannesburg, South Africa, between 3 September 2020 and 23 August 2021 [Location of the study area (shaded green) in Gauteng Province, South Africa. Redrawn and adapted from: File: Map of Gauteng with municipalities blank (2016).svg (Study summaryA search of ClinicalTrials.org (15 November 2022) reported that studies in outpatients represented just 6.5% (84/1,303) of all COVID-19 interventional studies started between Jan 1, 2020, and Dec 31, 2020. Less than half of these studies (35/84) had completed recruitment by November 2022. There were only two completed outpatient studies that recruited African patients; one investigated molnupiravir (NCT04575597) and the other was our study (NCT04532931) [There has been wide-ranging dialogue around the impact of COVID-19 on healthcare delivery and staff [