NCT06288893

SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19)

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SHEN211 Tablets in the Treatment of Patients With Mild and Moderate Novel Coronavirus Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: JKT Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets

Detailed description

A total of 30 patients with mild to moderate novel coronavirus infection (COVID-19) were enrolled and randomized in a 2:1 ratio to the experimental and placebo groups, and subjects received 5 days of oral administration of SHEN211 or SHEN211 placebo to assess the effectiveness of SHEN211 tablets in the treatment of mild to moderate COVID-19 patients.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	SHEN211 Tablets	SHEN211 tablets, participants will receive 330 mg (3 tablets) QD (once a day) on Day 1 and 110 mg (1 tablet) SHEN211 tablets QD orally on Days 2-5.
PROCEDURE	Placebo for SHEN211 Tablets	Placebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-01
• Completion: 2025-01-01
• First posted: 2024-03-01
• Last updated: 2024-03-04

Locations

1 site across 1 country: China