key: cord-0764643-spd3t0zb authors: Piovani, Daniele; Pansieri, Claudia; Peyrin-Biroulet, Laurent; Danese, Silvio; Bonovas, Stefanos title: A snapshot of the ongoing clinical research on COVID-19 date: 2020-05-18 journal: F1000Res DOI: 10.12688/f1000research.23843.1 sha: 837cbcd3064097a199ed0eea46188905ea46cec3 doc_id: 764643 cord_uid: spd3t0zb The pandemic of coronavirus disease 2019 (COVID-19) presents an unprecedented challenge to rapidly develop new diagnostic, preventive and therapeutic strategies. Currently, thousands of new COVID-19 patients are quickly enrolled in clinical studies. We aimed to investigate the characteristics of the COVID-19 studies registered in ClinicalTrials.gov and report the extent to which they have incorporated features that are desirable for generating high-quality evidence. On April 28, 2020, a total of 945 studies on COVID-19 have been registered in ClinicalTrials.gov; 586 studies are interventional (62.0%), the most frequent allocation scheme is the parallel group assignment (437; 74.6%), they are open-label and the most common primary purpose is the research on treatment. Too many of the ongoing interventional studies have a small expected sample size and may not generate credible evidence at completion. This might lead to a delayed recognition of effective therapies that are urgently needed, and a waste of time and resources. In the COVID-19 pandemic era, it is crucial that the adoption of new diagnostic, preventive and therapeutic strategies is based upon evidence coming from well-designed, adequately powered and carefully conducted clinical trials. This article is included in the Disease Outbreaks gateway. The pandemic of coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents an unprecedented challenge to rapidly develop new diagnostic, preventive and therapeutic strategies 1 . Currently, thousands of new COVID-19 patients present for care every day, and many are quickly enrolled in clinical studies. We aimed to investigate the characteristics of the COVID-19 studies registered in ClinicalTrials.gov 2 , and report the extent to which they have incorporated features that are desirable for generating high-quality evidence. We investigated the ClinicalTrials.gov website on April 28, 2020, using the search term: SARS- Our survey presents the current COVID-19 clinical research landscape. Several hundreds of clinical studies have been initiated all over the globe, and the number is growing. Most interventional studies incorporate randomisation, which is considered the hallmark of high-quality clinical trials 3 , while more than 40% are blinded. Studies are being conducted especially in the most affected areas: Europe and US. The number of COVID-19 cases in low to middle-income countries is still relatively low, also reflecting scarce testing, but is expected to rise in the next period. These countries will need more research on organizational measures, and trials on interventions that are affordable and applicable to those settings 4 . Most studies focus on adults and elderlies, while only few target children, possibly reflecting the observed burden of the disease. Additional effort is needed to ensure that minors are included in COVID-19 clinical research, so that therapeutic decisions are based upon high-quality evidence. No drug with proven clinical efficacy currently exists for SARS-CoV-2 infection. Despite the absence of solid evidence, several treatments are being currently used in clinical practice in several countries, with sometimes disastrous consequences 5 . Too many of the ongoing interventional studies have a small expected sample size, and may not generate credible evidence at completion 4 . This might lead to a delayed recognition of effective therapies that are urgently needed, and a waste of time and resources. In the COVID-19 pandemic era, it is crucial that the adoption of new diagnostic, preventive and therapeutic strategies is based upon evidence coming from well-designed, adequately powered and carefully conducted clinical trials. The Clinical Trials website can be accessed here: https:// clinicaltrials.gov/ This brief report is a survey of the current COVID-19 clinical research landscape. The number of clinical studies on COVID-19 is rapidly growing and it is important the investigation of whether these studies are incorporating features that are desirable for generating high-quality evidence. This survey performed this investigation and found that too many of the ongoing interventional studies have a small expected sample size. This might lead to delayed recognition of effective therapies and a waste of time and resources. This important evidence should guide the design of any future clinical study on COVID-19 and the decision of any funding body as well as the approval of any bioethics committee. For this reason, I consider this brief report important for the scientific community. There are a few minor suggestions for the authors: Table 1 : The presentation of the studies' characteristics will be improved if they are presented separately for interventional and observational studies (particularly for the intervention type and expected study size). In this way, the table will provide more information about the studies' characteristics for each study type (interventional and observational). Table 1 : It will be useful to report the type of randomization (such as blocking and block size). Is the study design appropriate and is the work technically sound? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes No competing interests were disclosed. Competing Interests: Reviewer Expertise: Epidemiology, Statistics, Research Methods, Public Health I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. The benefits of publishing with F1000Research: Your article is published within days, with no editorial bias You can publish traditional articles, null/negative results, case reports, data notes and more The peer review process is transparent and collaborative Your article is indexed in PubMed after passing peer review Dedicated customer support at every stage For pre-submission enquiries, contact research@f1000.com Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review PubMed Abstract | Publisher Full Text 2 CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials I have read it through, and it seems to be an interesting brief report. Some comments below: 74.2% of those studies are mention as "Randomized" and 40% as blinded, from researchers. Authors of this brief report can "discuss" those numbers and prepare readers that most of those may have a high risk of bias (maybe with no control group, or bias arising from the randomisation process, etc)."Additional effort is needed to ensure that minors are included in COVID-19 clinical research, so that therapeutic decisions are based upon high-quality evidence". I am not very sure if it is necessary to discuss this in the brief report Are all the source data underlying the results available to ensure full reproducibility?Are all the source data underlying the results available to ensure full reproducibility? No competing interests were disclosed. , which permits unrestricted use, distribution, and reproduction in any medium, provided the original Attribution License work is properly cited.