Characteristics of all 65 randomized COVID-19 trials planned to be conducted in Germany.
CLINICAL TRIALS ENDNOTE FREE TRIAL TRIAL
The aim of this study was to describe the German contribution to the worldwide COVID-19 clinical trial agenda, including all randomized clinical trials (RCTs) with German participants, that were registered during the first year of the pandemic. 1 Germany contributed to large-scale international studies such as REMAP-CAP 5 and WHO-SOLIDARITY, 6 and the German Federal Ministry for Education and Research (BMBF) provided 1.6 billion € for COVID-19-related research. 4 In the first 100 days, China, the US, Spain and France, had the largest share of the initiated trials, with many planned as international collaborations. 1 Nevertheless, there were remarkable efforts to conduct large adaptive pragmatic trials directly informing therapeutic decisions in COVID-19 patients: the UK Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial recruited 10,000 patients in two months, 2 the established Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) was rapidly adapted to COVID-19, 3 and the COVID-19 Solidarity Trial for COVID-19 Treatments (SOLIDARITY) sponsored by the World Health Organization (WHO), was conducted in six months. 1 However, this research agenda has been tainted by a multitude of small trials with 50 from the 700 trials aimed to include more than 1,000 participants. Almost 700 clinical trials were registered worldwide in the first 100 days, which planned to recruit almost 400,000 participants to assess interventions to treat or prevent COVID-19. The COVID-19 pandemic has led to an unprecedented volume and speed in the international clinical research agenda. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed. Most trials did not meet recruitment goals. Few trials delivered urgently needed evidence. Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. From the planned German participants, 13.4% were recruited (median 15 per trial (IQR 0 to 44).
Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345). Most trials investigated interventions to treat COVID-19 (86.2% 56/65), in hospitalized patients (67.7% 44/65), with industry funding (53.8% 35/65).
Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. We requested recruitment information from trial investigators as of April 2021. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide.
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