2.1. Trial Design and Oversight
PCR-confirmed SARS-CoV-2 infection
This phase 2, dose-range finding study utilized a randomized, single-blind, and placebo-controlled design to evaluate the antiviral activity, clinical efficacy, and safety of probenecid orally administered, 500 mg or 1000 mg b.i.d., versus placebo in non-hospitalized, symptomatic patients with PCR-confirmed SARS-CoV-2 infection. Patients were enrolled in a single center at PCMCs PGI Yashwantrao Chavan Memorial Hospital in Pune, India.The study was conducted in accordance with Good Clinical Practice guidelines and was approved by the local ethics committee (Skinovate Independent Ethics Committee, Pune, India). Written informed consent was obtained from all of the participants. The trial was designed by representatives of the sponsor. Safety oversight was performed by the sponsor and contract research organization (CRO). Data were collected by the investigator and site personnel, analyzed by statisticians employed by the CRO, engaged by the sponsor, and interpreted by the authors.