Profile of clinical trials with drugs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Spain.

BACKGROUND On 11 March 2020, World Health Organisation declared COVID-19 a pandemic. During the early stages, treatments lacking scientific evidence, such as hydroxychloroquine and later remdesivir, were used; meanwhile, clinical trials were being conducted in Spain to evaluate new therapies with greater scientific rigor. This article analyses the study profile, publication rate and completion of studies during the COVID-19 pandemic in Spain.

METHODS Meta-epidemiological, analytical, and retrospective study analyzing the characteristics and rate of completion of clinical trials with SARS-CoV-2-related drugs authorized in Spain between March 2020 and March 2021, focusing on treatment and prophylaxis. 179 clinical trials were reviewed using sources such as Registro Español de Estudios Clínicos, ClinicalTrials.gov, PubMed, Embase and TESEO. Statistical analysis was performed with SPSS v.26.

RESULTS 67.0% of the trials were national and 71.0% multicentre, with non-commercial sponsors (64.8%) and phase II (44.7%) and phase III (48.0%) studies being the most common. The majority employed a comparative design (93.9%), preferentially focused on treatment (91.1%) versus prophylaxis of SARS-CoV-2 disease, with a predominance of therapeutic repositioning (72.1%). Notably, studies initiated during the first wave of the pandemic (March-June 2020) were mostly non-international, non-commercial, non-placebo-controlled and aimed at drug repositioning. Some 21.2% of the clinical trials closed prematurely, mainly due to recruitment problems, involuntary discontinuation or failure to achieve expected efficacy. By the end of the study, 41.1% of the clinical trials had a final report and 31.3% published their results, most of them (71.9%) in first quartile journals. Statistically significant associations were found between the publication of results and variables such as multicentre, not having closed prematurely, having a final report, and phase III trials. The fact that a large number of clinical trials were not published (68.7%) represents a missed opportunity in terms of knowledge.

CONCLUSION We conclude that there is a need to improve transparency, record all results- including negative ones- and review key aspects of design and funding, as recommendations for future research, including in health emergencies.