NCT05381519

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Wuhan Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	DXP604	1800mg，IVgtt

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-06-01
• Completion: 2022-09-01
• First posted: 2022-05-19
• Last updated: 2022-05-19