NCT04533347

Tafenoquine in Patients With Mild to Moderate COVID-19

A Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Oral Tafenoquine Versus Placebo in Patients With Mild to Moderate COVID-19 Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: 60 Degrees Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease.

Detailed description

The TQ 2020\_06 study is a double-blind placebo-controlled, Phase 2 clinical trial that plans to enroll approximately 275 patients with mild to moderate infection with COVID-19. Patients will undergo a brief screening period before being randomized to receive either self-administer 200 mg tafenoquine or matching placebo for 10 days. Following the treatment period, patients will have a follow up visit at study Day 28 (28 days after the first dose of study medication). The study's primary efficacy endpoint is proportion of patients with clinical recovery from COVID-19 symptoms on Day 14 in patients with mild to moderate COVID-19 disease compared with placebo.

Conditions

• COVID 19 Disease

Interventions

Type	Name	Description
DRUG	Tafenoquine Oral Tablet	Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
DRUG	Placebo	Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.

Timeline

• Start date: 2021-02-19
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-08-31
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study