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

Tags: Oral
Yang M1, Shang Y1, Tian Z2, Xiong M2, Lu C3, Jiang Y1, Zhang Y4, Zhang Y1, Jin X5, Jin Q6, Zhang Y1, Willcox M7, Liu J3
1Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 2Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing; Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 3Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing; Institute of Integrated Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University, Guangzhou, 4School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 5Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, 6Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 7School of Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton

Background: The World Health Organization characterized the 2019 novel coronavirus disease (COVID-19) as a pandemic on March 11. As of March 31, 803,541 people were confirmed infected with COVID-19 in 201 countries, areas or territories with cases. As a novel coronavirus disease, there is no specific treatment to guide the clinical practice, and majority of care is under the guidance of clinical experience and symptomatic treatment. The great effort has been made for clinical researches and the first clinical trial was registered on China clinical trials registry since Jan 23 2020. Facing the increasing ongoing trials, it would be important to understand the research questions and characteristics of these registered studies. We were also interested in how the emerging evidence can inform clinical practice by providing reliable evidence in the prevention and treatment of COVID-19.

Objectives: To review the characteristics of registered trials on COVID-19 and to 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. Promising trials were screened based on study design, rationale, and resource availability.

Results: 393 studies registered between Jan 23 to Mar 3 2020 were identified and 380 (96.7%) studies were from mainland China, and 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. 202 studies (51.4%) were randomized controlled trials (RCTs). The average sample size was 1061 and ranged from 8 to 150,000 per study. 67.3% therapeutic studies (179 of 266) tested Western medicines including antiviral drugs (17.3%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 15 (5.6%) on Chinese medicines, and 72 (27.1%) on integrated therapy of Western and Chinese medicines. Only 31 studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most reported secondary outcomes were symptoms and signs (47.0%). 106 studies (27.0%) were funded by the government, and 268 (68.2%) demonstrated ethical approval. 67.3% studies (179 of 266) had not started recruiting till Mar 3. Only 9 RCTs were evaluated as 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.

Patient or healthcare consumer involvement: Trials on COVID-19 concern patients and healthy people worldwide.