Baseline results of a living systematic review for COVID-19 clinical trial registrations

Wellcome Open Research

article

Brittany J. Maguire¹  Alistair R.D. McLean¹  Sumayyah Rashan¹  Emilia Sitsofe Antonio²  Jayshree Bagaria¹  Zineb Bentounsi³  Matthew Brack¹  Fiona Caldwell¹  Verena Ilona Carrara²  Barbara Wanjiru Citarella¹  Prabin Dahal¹  Vitalis Fambombi Feteh⁶  Marius H.B. Guérin¹  Kalynn Kennon¹  Kathinka Bilton Lahaut⁸  Gerald Jamberi Makuka⁹  Roland Ngu¹  Sopuruchukwu Obiesie²  Caitlin Richmond¹  Sauman Singh-Phulgenda¹  Samantha Strudwick¹  Carina S.B. Tyrrell^1,10  Austin Schwinn^1,12  David King^1,12  Paul N. Newton¹  Ric N. Price²  Laura Merson¹  Kasia Stepniewska¹  Philippe J. Guérin¹ 

[1] Infectious Diseases Data Observatory;Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford;Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford;Shoklo Malaria Research Unit, Mahidol-Oxford University Research Unit, Mahidol University;Institute of Global Health, Faculty of Medicine, University of Geneva;Nuffield Department of Medicine, Big Data Institute, University of Oxford;Health and Human Development ,(2HD) Research Network;Faculty of Medicine, University of Oslo;Muhimbili University of Health and Allied Sciences;Public Health England;MRC Epidemiology Unit, University of Cambridge;Exaptive, Inc.;Lao-Oxford-Mahosot Hospital-Wellcome Research Unit ,(LOMWRU), Microbiology Laboratory, Mahosot Hospital;Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University;Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University;International Severe Acute Respiratory and Emerging Infection Consortium

关键词: Living systematic review;    COVID-19;    SARS2-CoV2;    coronavirus;    clinical trials;    emerging infections;   

DOI  :  10.12688/wellcomeopenres.15933.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: Since the coronavirus disease 2019 (COVID-19) outbreak was first reported in December 2019, many independent trials have been planned that aim to answer similar questions. Tools allowing researchers to review studies already underway can facilitate collaboration, cooperation and harmonisation. TheInfectious Diseases Data Observatory (IDDO) has undertaken a living systematic review (LSR) to provide an open, accessible and frequently updated resource summarising characteristics of COVID-19 study registrations.Methods: Review of all eligible trial records identified by systematic searches as of 3 April 2020 and initial synthesis of clinical study characteristics were conducted. In partnership withExaptive, an open access, cloud-based knowledge graph has been created using the results. Results: There were 728 study registrations which met eligibility criteria and were still active. Median (25th, 75th percentile) sample size was 130 (60, 400) for all studies and 134 (70, 300) for RCTs. Eight lower middle and low income countries were represented among the planned recruitment sites. Overall 109 pharmacological interventions or advanced therapy medicinal products covering 23 drug categories were studied. Majority (57%, 62/109) of them were planned only in one study arm, either alone or in combination with other interventions. There were 49 distinct combinations studied with 90% (44/49) of them administered in only one or two study arms. The data and interactive platform are available athttps://iddo.cognitive.city/.Conclusions:  Baseline review highlighted that the majority of investigations in the first three months of the outbreak were small studies with unique treatment arms, likely to be unpowered to provide solid evidence.  The continued work of this LSR will allow a more dependable overview of interventions tested, predict the likely strength of evidence generated, allow fast and informative filtering of relevant trials for specific user groups and provide the rapid guidance needed by investigators and funders to avoid duplication of efforts.

【 授权许可】

CC BY