CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,208 enrolled
Drug / intervention
SIM0417 +1 moredrug
Likely dose
SIM0417 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05506176
NCT05506176Phase 3Completed

A Multicenter, Randomized, Double-blind, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19

Jiangsu Simcere Pharmaceutical Co., Ltd.·interventional·Posted Aug 18, 2022·Updated May 6, 2023

In Brief

A Phase 3 clinical trial evaluating SIM0417 and Placebo for COVID-19. Completed, enrolled 1,208 participants across 35 sites.

Detailed Summary

This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedAug 18, 2022
Enrollment StartAug 19, 2022
Primary CompletionJan 23, 2023
Study CompletionMar 21, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.9 years ago

Interventions

SIM0417drug

dose of 750 mg SIM0417 with 100 mg ritonavir.

Placebodrug

Placebo (tablet)