NCT04523181

Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients

A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients With Mild to Moderate Pneumonia Due to COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia due to COVID-19, as measured by the proportion of patients alive and free of respiratory failure.

Detailed description

This is a randomized, double blind, placebo controlled, Phase 2, proof of concept study in hospitalized patients with mild to moderate pneumonia due to COVID 19. Written informed consent must be obtained from all patients during screening. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive antroquinonol or placebo for 14 days in combination with SoC therapy per local SoC policies.

Conditions

• Covid-19

Interventions

Type	Name	Description
DRUG	Antroquinonol	double-blind for antroquinonol and Placebo with same out-look and same frequency.
OTHER	Placebo	Capsule without active compound

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2020-08-21
• Last updated: 2023-12-13
• Results posted: 2023-12-13

Locations

15 sites across 3 countries: United States, Argentina, Peru

Regulatory

• FDA-regulated drug study