FABIANA B. IBELLI1 , RAÚL BOZZO2 , MARÍA VICTORIA IANNANTUONO1 , MARÍA EMILIA MOLINA1 , JULIETA PEDERODA1 , RUBÉN IANNANTUONO1 , GRUPO DE INVESTIGADORES3
COVID-19 in subjects at risk participating in clinical trials during the pandemic in Argentina
Introduction: There is little information on the presence of COVID-19 in clinical trial participants. The objective of the study was to evaluate the cumulative infection rate for SARS-CoV-2 in this population. Additionally, we investigated the risk, lethality, and mortality from COVID-19.
Methods: The design was observational retrospective that included adult subjects participating in clinical intervention trials approved by our ethics committee during the first two years of the pandemic (March 31, 2020 to March 31, 2022). Pediatric, observational, shortterm, and inpatient protocols were excluded.
Results: We included 513 adult subjects who participated in clinical trials during the first two years of the COVID-19 pandemic. Patients with COVID-19 were characterized as being 59.7 ± 13.7 years old (50% female), and 92% had an increased risk of fatality from COVID-19. The cumulative rate of COVID-19 was 9.74% (95% CI: 7.32-12.64%) and its confidence intervals were below 17% of the population aged 60 to 69 in Argentina (p<0.0001). The case fatality rate for COVID-19 was 14% (95% CI: 5.8%-26.7%) and its confidence intervals were above 2.45% of the population aged 50 to 69 in Argentina (p< 0.0001).
Conclusion: The rate of COVID-19 in adult subjects participating in clinical trials was below the figures for the Argentine population of similar age. The fatality rate was above the population figures, and it is explained by the high risk of the population.
Keywords: COVID-19, clinical trials, infection, risk, lethality, mortality