Soon after the outbreak of COVID-19, many clinical trials about COVID-19 were registered and conducted. In 2020, our team analyzed research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19.
Thus, we decided to conduct a new study in which we ought to examine what the trial authors decided to proclaim SoC for an emergent disease. In our analysis, published recently in BMC Medical Research Methodology, we screened 6022 records from the WHO ICTRP clinical trial registry, 9358 preprint records and 356 records from Cochrane COVID–19 Study Register related to COVID-19. We found 737 trials that reported they used standard, usual, conventional, or routine treatment for COVID-19.
This study has highlighted multiple problems. Firstly, our study indicates that many experimental, i.e. investigational interventions, were described as SoC in early COVID-19 trials, even though their risk/benefit profile in targeted patients was unknown. Secondly, many of those interventions were later proven ineffective or even detrimental to patients suffering from COVID-19.
It is important to emphasize that this was not a study that aimed to determine the efficacy and safety of any type of intervention for COVID-19. We know that many interventions used early in the COVID-19 pandemic to treat patients can be considered experimental as the disease was previously unknown. Instead, we intended to analyze which interventions the trialists labelled as SoC.