Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial

In this study, the central randomization system (IWRS, an interactive network response system based on network) is used to randomise the groups. The subjects who met the entry criteria were randomly divided into the experimental group and the control group according to the proportion of 2:1. In this study, the block randomized grouping method is used, and the block length is 6. The random grouping program is set up by statistical and computer professionals in the randomization process.Blinding (masking)This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment.Numbers to be randomised (sample size)750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2 (Anluohuaxian combined with regular treatment group):1 (regular treatment group).Trial StatusProtocol version number 3.0, 10th April 2020. The recruitment has not yet started.Actual Study Start Date: April 1, 2020Estimated Primary Completion Date: June 1, 2020Estimated Study Completion Date: December 1, 2020Trial registrationClinicalTrials.gov ID:NCT04334265. Registered on 3 April 2020Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Source: Trials - Category: Research Source Type: clinical trials