A Survey of Characteristics and Potential Contribution of Registered Studies for 2019 novel coronavirus disease (COVID-19) (preprint)

ABSTRACT

Background The World Health Organization characterized the 2019 novel coronavirus disease (COVID-19) as a pandemic on March 11. Many clinical trials on COVID-19 have been registered, and we aim to review the characteristics of the trials and provide guidance for future trials to avoid duplicated effort.Methods All the studies on COVID-19 registered before Mar 3, 2020 on eight registry platforms worldwide were searched and the data of design, participants, interventions, and outcomes were extracted and analyzed. The most promising trials were screened based on study design, rationale, and resource availability.Results 393 studies registered were identified until Mar 3 2020 and 380 (96.7%) studies were from mainland China, while 3 in Japan, 3 in France, 2 in the US, and 3 were international collaborative studies. 363 studies (92.4%) recruited participants from hospitals and 266 studies (67.7%) aimed at therapeutic effect, others were for prevention, diagnosis, prognosis, etc. 202 studies (51.4%) were randomized controlled trials (RCTs). The average sample size was 1061 and ranged from 8 to 150,000 per study. 177 out of 266 therapeutic studies (66.5% ) tested Western medicines including antiviral drugs (17.7%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 16 (6.0%) on Chinese medicines, and 73 (27.4%) on integrated therapy of Western and Chinese medicines. 14 Chinese medicines had its clear rationale for evaluation of therapeutic effects. 31 studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most designed secondary outcomes were symptoms and signs (47.0%). 106 studies (27.0%) were funded by the government, and 268 (68.2%) demonstrated ethical approval. 45.5% studies (179 out of 266) had not started recruiting till Mar 3. Eight RCTs were evaluated as the most promising trials.Conclusions Majority of the studies focused on assessing therapeutics for COVID-19 but inappropriate outcome setting, delayed recruitment and insufficient numbers of new cases in China implied many studies may fail to complete. Strategies and protocols of the studies with robust and rapid data sharing from international collaboration are warranted for emergency public health events, helping to accelerate priority setting for timely evidence-based decision-making.