A Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19

Summary

A phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of DXP604 in patients with mild to moderate COVID-19. By determination of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) virus in nasopharyngeal swab samples by reverse transcription quantitative polymerase chain reaction (RT-qPCR) from baseline (2 h ± 30 min before dosing) to Viral load changes on day 8,to evaluate the efficacy of DXP604 monotherapy in patients with mild to moderate coronavirus disease 2019 (COVID-19). It was assumed that the difference in viral load change of SARS-CoV-2 virus from baseline (2 h ± 30 min before administration) to day 8 in nasopharyngeal swab samples by RT-qPCR between the experimental drug group and the placebo group was -1.00 log10 copies/mL.The null and alternative hypotheses comparing the experimental drug group with the placebo group are set as follows: H0：µ1 = µ2 H1：µ1 ≠ µ2

Timeline

Start

2022-05

Primary completion

2022-06

Completion

2022-09

Outcome

Missed primary endpoint

release “The trial did not meet the primary efficacy endpoint of viral load change in nasopharyngeal swabs at Day 8.” beonemedicines.com ↗

Drugs

Indications