Early COVID-19 treatment clinical trials: so much work, so many lost opportunities.

Abstract Background The Covid-19 pandemic has raged on and heavy clinical research have been promoted worldwide. We aimed to assess the adequacy of treatment clinical trials set forth as early response to COVID-19 pandemic.Methods First, we performed a systematic review of trial registries. The World Health Organization International Trials Registry Platform and national trial registries were searched for COVID-19 trials through April 19th, 2020. For each record, independent researchers extracted interventions, participants, and methodological characteristics. Second, we evaluated on September 14th, 2020 the recruitment status and availability of results of COVID-19 treatment trials previously identified.Results On April 2020, a total of 580 trials evaluating COVID-19 treatment were registered. Reporting quality was poor (core participant information was missing in 24.1% to 92.7%). Between 54.0% to 93.8% of the trials did not plan to include older people and people at higher baseline risk. Most studies were randomised (67.9%), single-centre (58.3%), non-industry funded (81.1%), to be conducted in China (47.6%), with a median duration of 184 days and a median sample size of 100 participants. Core endpoints (mortality, clinical status, and hospitalization length) were planned to be assessed in 5.2% to 13.1% of the trials. Five months later, 66 trials (11.4%) are reported as “Completed”, and only 46 (7.9%) have public results available. 144 of 580 trials (24.8%) are either under the status “Not yet recruiting” or “Suspended”, and 18 (3.1%) trials were prematurely stopped (“Terminated” or “Withdrawn”) The number of completed trials and trials with results are much lower than anticipated, considering the planned follow-up.Conclusions Our results raise concern regarding the success of the initial global research effort on COVID-19 treatment. The clinical and methodological characteristics of early COVID-19 treatment trials limit their capability to produce clear answers to critical questions in the shortest possible time.