Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience

Abstract

<i>Background and aim</i>: The University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC) continued to provide essential services while safeguarding the safety of study participants and research staff during the COVID-19 pandemic. A COVID-19 Infection Prevention and Control (IPC) Taskforce formed in March 2020 drafted the institutional IPC Standard Operating Procedures (SOP) to prevent, mitigate, and manage SARS-CoV-2 infections. Identifying staff infected with SARS-CoV-2, isolation of positive cases and promoting risk reduction measures were key strategies to prevent workplace transmission. The SOP included a routine self-completed risk assessment questionnaire for staff prior to entering Clinical Trials Unit (CTU) facilities each day in addition to the recommended non-pharmaceutical preventative measures. Staff reporting a risk factor of greater than zero were assessed by a clinician and offered real time COVID-19 testing. Details of confirmed cases were reported to the IPC Taskforce and documented in the CTU COVID-19 tracker by the Monitoring and Evaluation Department. COVID-19 vaccine uptake was reported weekly by each clinical research site from February 2021. <i>Methods</i>: We conducted a desk review of this operational information, from March 2020 to August 2021, which was recorded as de-identified data in the CTU COVID-19 Tracker from ten active sites and 247 research staff. Data was tabulated in Microsoft Excel and analyzed using Stata 15.0. Results: A total of 753 SARS-CoV-2 tests were conducted (560 PCR tests and 193 Rapid Antigen tests) on CTU staff. Fifty-three SARS-CoV-2 cases were identified; 1 (1.9%) from March-August 2020 (first wave), 15 (28.3%) from September 2020- February 2021 (second wave; 2 deaths) and 37 (69.8%) from March-August 2021 (third wave; 1 death). Vaccination uptake was 84.6% (209/247) among staff between February and August 2021. Of 37 confirmed cases occurring after vaccines became available, 27 (73%) were fully vaccinated, 4 (10.8%) had received 1 vaccine dose and 6 (16.2%) were not vaccinated. Close contact with a known case was reported by 23 (43.4%) of whom 11 (20.7%) was presumed associated with workplace contact, and 10 (18.9%) a family member. Association with positive cases was unknown in 30 (56.6%) cases. <i>Conclusion</i>: We observed a significant rate of breakthrough COVID-19 infections in our Research Unit in the background of 84.6% vaccine uptake. Clinical trial units should consider having mechanisms in place to identify, test and isolate SARS-CoV-2 cases among staff for containment, safety, and continuity of research activities. Our staff remained at risk of acquiring COVID-19 even after vaccination, therefore non-pharmaceutical COVID-19 preventative measures remain critical in preventing SARS-CoV-2 transmission.