The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial

In this study, block randomization will be used, in blocks of 6.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 randomised210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140): 1(regular treatment group, n=70).Trial StatusProtocol version number 3.0, 10th April 2020First Patient, first visit 17th March 2020; recruitment end date anticipated June 1, 2020.Trial registrationClinicalTrials.gov,NCT04333589, April 3, 2020. Registered April 3, 2020.Full 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