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?:abstract
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BACKGROUND The different features, if any, between non-industry-sponsored medicine trials conducted in the 5 largest European countries and the USA to treat COVID-19 patients registered in the first trimester of the pandemic are unknown. METHODS A search was conducted on four databases looking for ongoing medicine randomized controlled trials (RCTs) and non-RCTs registered current through 25-April-2020. All trials assessing medicines on prophylaxis, special populations, assessing non-medicines and convalescent plasma, were excluded. Of each trial, medicines assessed, design, sample size, registration date, study start and study completion dates, and type of patients were registered. RESULTS 106 trials were identified, 62 in Europe and 46 in the USA ─with two conducted in both regions. In Europe 90% of trials were on hospitalized patients, and 70% in the USA (p<0.01). Mean of the estimated time to completion were 7.8 and 13,6 (p<0.001) months for European and USA trials, respectively. Multicenter trials were more frequent in Europe (63%) than in the USA (41%) (p=0.031). Masked RCTs were more frequently run in the USA than in Europe (p<0.001). RCTs on hospitalized patients were more commonly conducted in Europe (91%) than in the USA (65%) (p<0.01). CONCLUSIONS Features of early registered COVID-19 RCTs with medicines in Europe and America had remarkable differences.
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