NCT04986176

HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (estimated)
• Sponsor: Applied Biology, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.

Detailed description

This study is designed as a prospective, superiority, interventionist, placebo-controlled, double-blinded, randomized parallel assignment study. The study evaluates the efficacy and safety of HC- 1119. Participants will be screened for eligibility; the assessment should be completed prior to any randomization to avoid screening failures to a maximum extent. Eligible participants (men and women) will be randomized 1:1 between arms (HC-1119 and placebo). HC-1119 and placebo will be administered orally. The dosing regimen is 160 mg daily for 14 consecutive days. All patients will receive in parallel the standard treatment for COVID -19, according to the institution's protocol. An electronic program will be used to manage randomization and drug shipment. The whole process will be handled in a manner that is blinded for the treatment received to all involved study personnel. The study follow up period will be 28 days after the first treatment.

Conditions

• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
DRUG	HC-1119	oral
DRUG	Placebo	oral

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-08-02
• Last updated: 2022-02-18