NCT05092503

JINZHEN for Treatment of Mild to Moderate COVID-19

A Phase I/Ⅱ Randomized Controlled Proof-of-concept Study to Evaluate the Safety and Efficacy of JINZHEN Granules for Oral Solution in Participants With Mild to Moderate COVID-19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lianyungang Kanion Group, Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

JINZHEN is a botanical drug that contains eight chemical constituents extracted from plant, mineral and animal origin raw materials. This study is to evaluate the safety and efficacy of JINZHEN Granules for Oral Solution compared to placebo for treatment of mild to moderate COVID-19 outpatients.

Detailed description

The study is a randomized, double-blind, placebo-controlled, proof of concept study with four groups (low dose treatment group, middle dose treatment group, high dose treatment group, and placebo group). Study eligibility will be assessed during screening. Study participants will be randomized in a 3:1 ratio to receive JINZHEN Granules for Oral Solution or placebo granules for 14 days. During the 14-day clinical study, participants will be assessed daily at home using e-diary to collect clinical data and in person visit on Day 7 and Day14. All subjects will undergo a series of efficacy, safety, and laboratory assessments. Clinical observation endpoints will be assessed at day 7 and day 14. Interim analysis will be performed to evaluate efficacy and safety of 7-day and 14-day treatment.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	JINZHEN Granules for Oral Solution	JINZHEN granules will be dissolved in drinking water and administered orally.
DRUG	Placebo	Placebo granules will be dissolved in drinking water and administered orally.

Timeline

• Start date: 2022-05-26
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2021-10-25
• Last updated: 2024-03-20

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study