A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Deluxe Health Center LLC
Miami, Florida, United States
Hope Clinical Trials
Miami, Florida, United States
F&T Medical Research, Inc.
Miami, Florida, United States
Kendall South Medical Center, Inc.
Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
Clinical recovery from COVID-19 symptoms was defined as: temperature \< or equal to 37.7 degrees Celsius (surface by infra-red or oral), respiratory rate \< or equal to 24/minute on room air, shortness of breath is absent on a patient-report scale, and cough is mild or absent on a patient-reported scale.
Time frame: Day 14 [± 1 day]
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Number and percentage of patients with COVID-19 clinical symptoms at Day 14 by individual symptoms (stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting , diarrhea, sense of smell, and sense of taste)
Time frame: Day 14 [± 1 day]
Decreases the Hospitalization Rate Due to COVID-19 by Day 14
Number and percentage of patients hospitalized due to COVID-19 symptoms (excluding non-COVID 19 causes including admittance for other upper respiratory infections and admittance only for administrative or observations purposes)
Time frame: Day 14 [± 1 day]
Decreases the Number of Medical Follow-up Visits by Day 14.
Number and Percentage of Patients by Number of Medical Follow-up Visits (Doctor/ER Visit)
Time frame: Day 14 [± 1 day]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Miami, Florida, United States
Skyline Medical Center
Elkhorn, Nebraska, United States
Burke Primary Care
Morgantown, North Carolina, United States
AFC Urgent Care
Easley, South Carolina, United States
Centex Studies
Brownsville, Texas, United States
Care United
Forney, Texas, United States
Clinical Trial Network
Houston, Texas, United States