OBJECTIVES:

Observational and pragmatic trials have a critical role in drug and medical technology development. For the COVID-19 pandemic, a large number of new trials have been initiated to help identify a cure, of which there is a large proportion of observational studies. This analysis is designed to provide a clear and accurate understanding of all observational studies, their designs, strengths and limitations.

METHODS:

All observational studies in clinicaltrials.gov evaluating patients with COVID-19 infections from Jan 2020 were analyzed up until June 30th (included), and will be refreshed continuously. Studies were categorized based on treatment type (diagnostic vs devices vs other), study design, duration and location. Natural language processing methods were deployed to further classify studies based on treatments and designs.

RESULTS:

938 distinct observational studies, recruiting for 18,524,818 patients were identified, of which 719 ongoing studies, 126 completed, 2 were withdrawn, 64 active, not recruiting and 27 enrolling by invitation. Of the 719 ongoing studies, 466 had a cohort-based design, 87 were case-only and 57 were case control studies, remaining studies with other designs. 16.6% studies were aimed at diagnostic tests including Anti-SARS-CoV2 serology and breath tests. One third of all studies identified a completion date prior to November 1^st, for an average study duration of 498 day. Main study locations included: 163 ongoing studies based out of France, 97 in US and 40 in Italy.

CONCLUSIONS:

The clinical and economic gravity of the SARS-CoV-2 pandemic has prompted initiation of a large number of observational studies. Reporting of observational studies is not mandatory and our analysis may therefore not be exhaustive, however, continuous analysis of ongoing studies and outcomes is important to ensure a coordinated understanding of ongoing research and therefore accelerate the time to treatment.