key: cord-292912-ufcvecwo authors: Qiu, Ruijin; Wei, Xuxu; Zhao, Mengzhu; Zhong, Changming; Zhao, Chen; Hu, Jiayuan; Li, Min; Huang, Ya; Han, Songjie; He, Tianmai; Chen, Jing; Shang, Hongcai title: Outcome reporting from protocols of clinical trials of Coronavirus Disease 2019 (COVID-19): a review date: 2020-03-08 journal: nan DOI: 10.1101/2020.03.04.20031401 sha: doc_id: 292912 cord_uid: ufcvecwo Objectives: To examine heterogeneity of outcomes in protocols of clinical trials of Coronavirus Disease 2019 (COVID-19) and to identify outcomes for prioritization in developing a core outcome set (COS) in this field. Design: This study is a review. Data sources: Databases of ICMJE-accepted clinical trial registry platform were searched on February 14, 2020. Eligibility Criteria: Randomized controlled trials (RCTs) and non-RCTs of COVID-19 were considered.Conditions of patients include common type, severe type or critical type. Interventions include traditional Chinese medicine (TCM) and Western medicine. We excluded trials that for discharged patients, psychological intervention and complications of COVID-19. Data extraction and synthesis: The general information and outcomes, outcome measurement instruments and measurement times were extracted. The results were analysed by descriptive analysis. Results: 19 registry platforms were searched. A total of 97 protocols were included from 160 protocols. For protocols of TCM clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of outcomes were reported only once; the most frequently reported outcome was time of SARS-CoV-2 RNA turns to negative. 27 (27/76, 35.53%) outcomes were provided one or more outcome measurement instruments. 10 outcomes were provided one or more measurement time frame. For protocols of western medicine clinical trials, 126 outcomes from 17 outcome domains were reported; almost half (62/126, 49.21%) of outcomes were reported only once; the most frequently reported outcome was proportion of patients with negative SARS-CoV-2. 27 outcomes were provided one or more outcome measurement instruments. 40 (40/126, 31.75%) outcomes were provided one or more measurement time frame. Conclusion: Outcome reporting in protocols of clinical trials of COVID-19 is inconsistent. Thus, developing a core outcome set is necessary. Keywords: Outcomes; clinical trials, COVID-19; review. 1. This review is the first to describe variation in outcomes, outcome measurement instruments and outcome measurement time reporting in clinical trials for Coronavirus Disease 2019 (COVID-19). 2. All the database of ICMJE-accepted clinical trial registry platform were searched, and randomized controlled trials and observational studies were considered. 4. The aim of this review was to provide a list of outcomes for clinical trials of COVID-19, both interventions of Traditional Chinese Medicine and western medicine were considered. 5. When the searching was conducted, no clinical trials were registered by countries out of China, so all of included protocols were from China. shown in Figure 1 . Figure 6 . All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the . In the 17 outcome domains of protocols of western medicine clinical trials, 5 outcome domains (adverse events/effects, delivery of care, economic, metabolism and nutrition outcomes, mortality/survival) consisted of only one outcome. These outcomes are reported between 1 and 36 times, and the median outcome reporting time is 1. Respiratory, thoracic and mediastinal outcomes included the largest number of outcomes, which includes 31 outcomes; chest imaging is reported more frequently than other outcomes. The number of outcomes in different outcome domains in protocols of western medicine clinical trials is shown in Figure 7 . This review is the first to evaluate the outcome reporting of protocols of TCM and western medicine clinical trials for treating COVID-19. The results showed variations in the outcome reporting. For outcome measurement instruments/outcome definitions and outcome measurement time, there is also heterogeneity. However, many primary investigators did not provide outcome measurement instruments/outcome definitions or outcome measurement time. It is difficult to predict results of clinical trials now. But it is obvious that these problems may result in the exclusion of some studies from systematic reviews/meta-analyses due to the heterogeneity of outcomes or outcome measurements. It is a waste. In this review, we find that there are more than 40 duplicated outcomes between protocols of TCM and western medicine clinical trials. No matter for clinical trials of TCM or western medicine, etiological test, chest imaging, respiratory symptoms, temperature, mortality/survival and adverse events are very important. These outcomes are relevant to the prognosis of disease and safety of therapy. Because of no specific therapy can be used in the treatment of COVID-19, it is necessary and urgent to conduct clinical trials, no matter what the interventions are. We believe that it is important to develop a COS for clinical trials of TCM and western medicine for treating COVID-19, so that the efficacy of different interventions can be compared and merged in systematic review/meta-analysis. All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the . https://doi.org/10.1101/2020.03.04.20031401 doi: medRxiv preprint author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the . author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 63. Wu C. Nasal high-fow preoxygenation assisted fibre-optic bronchoscope intubation in patients with critical All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the All rights reserved. No reuse allowed without permission. author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the . https://doi.org/10.1101/2020.03.04.20031401 doi: medRxiv preprint author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint (which was not peer-reviewed) is the . https://doi.org/10.1101/2020.03.04.20031401 doi: medRxiv preprint A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery A prospective comparative study for Xue-Bi-Jing injection in the treatment of novel coronavirus pneumonia (COVID-19) Clinical Controlled Trial for Traditional Chinese Medicine in the treatment of Novel Coronavirus Pneumonia Chinese Herbal medicine for Severe nevel coronavirus pneumonia (COVID-19): a Randomized Controlled Trial A randomized controlled trial of integrated TCM and Western Medicine in the treatment of severe novel coronavirus pneumonia A single arm study for combination of traditional Chinese and Western Medicine in the treatment of novel coronavirus pneumonia (COVID-19) Combination of traditional Chinese medicine and western medicine in the treatment of common type novel coronavirus pneumonia (COVID-19) A single arm study for evaluation of integrated traditional Chinese and western medicine in the treatment of novel coronavirus pneumonia A randomized, open-label study to evaluate the efficacy and safety of low-dose corticosteroids in hospitalized patients with novel coronavirus pneumonia Clinical study of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by Noval Coronovirus 2019-nCoV: a Prospective Efficacy and Safety of Darunavir and Cobicistat for Treatment of Pneumonia Caused by 2019-nCoV (DACO-nCoV Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia Mild/Moderate 2019-nCoV Remdesivir RCT Severe 2019-nCoV Remdesivir RCT Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia Efficacy and Safety of Hydroxychloroquine for Treatment of Pneumonia Caused by 2019-nCoV ( HC-nCoV Efficacy of therapeutic effects of hydroxycholoroquine in novel coronavirus pneumonia 79. Qin N. The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection (ELACOI) Patients Infected With 2019 Novel Coronavirus Washed Microbiota Transplantation for Patients With 2019-nCoV Infection Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients Clinical study of nebulized Xiyanping injection in the treatment of novel coronavirus pneumonia Convalescent plasma for the treatment of severe novel coronavirus pneumonia (COVID-19): a prospective randomized controlled trial Cohort Study of Novel Coronavirus Pneumonia (COVID-19) Critical Ill Patients A multicenter, randomized, open label, controlled trial for the efficacy and safety of ASC09/ Ritonavir compound tablets and Lopinavir/ Ritonavir (Kaletra) and Arbidol tablets in the treatm ent of novel coronavirus pneumonia (COVID-19) A study for the efficacy of hydroxychloroquine for mild and moderate COVID-19 infectious combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency A randomized, open-label, blank-controlled, multicenter trial for Polyinosinic-Polycytidylic Acid Injection in the treatment of novel coronavirus pneumonia Clinical Application of ECMO in the Treatment of Patients with Very Serious Respiratory Failure due to novel Coronavirus Pneumonia (COVID-19) Immunomodulatory Therapy for Severe Novel Coronavirus Pneumonia (COVID-19) Clinical Study for Anti-aging Active Freeze-dried Powder Granules in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19) Clinical Study for Umbilical Cord Blood Mononuclear Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19) Clinical Study for Cord Blood Mesenchymal Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19) Clinical Study of Cord Blood NK Cells Combined with Cord Blood Mesenchymal Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia Immunoregulatory Therapy for Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Not required. The data is from public database and does not include identifiable patient data.