Tafenoquine in Patients With Mild to Moderate COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID 19 Disease

Intervention / Treatment
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* Drug: Tafenoquine Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged ≥18 years of age; Laboratory confirmed infection with COVID-19 virus by an FDA-authorized SARS-Cov-2 RT-PCR; Able and willing to give written informed consent. Willing to keep an electronic diary from Study Day 1 to Study Day 13 (± 1 day) and Study Day 15 (± 1 day) to Study Day 28 (± 1 day) Willing to have daily phone or videoconferences with study team personnel from Study Day 1 to Day 13 (± 1 day) and Day 28 At least one of the following clinical symptoms of COVID-19 infection within the 4 days prior to and inclusive of the day of screening: Respiratory rate ≥ 24/min New cough or shortness of breath that has presented within the last 4 days Fever - temperature 37.7°C [oral or skin surface] Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of the study. Able to take ARAKODA or KODATEF according to Prescribing Information Have been symptomatic no longer than 7 days when the first dose of study medication is administered. If female, agree to use an acceptable method of birth control from the time of consent through 56 days after the last dose of study drug. Exclusion Criteria: Have one of the contraindications for ARAKODA or KODATEF in the prescribing information (section 16.1) including: G6PD deficiency Breastfeeding Psychotic disorder or current psychotic symptoms Known hypersensitivity reaction to TQ Evidence of severe or critical illness, defined by at least one of the following: Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤93% on room air Respiratory failure defined based on resource utilization requiring at least one of the following: i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) ii. Shock (defined by systolic blood pressure < 90 mmHg, or diastolic blood pressure <60 mmHg or requiring vasopressors) iii. Multi-organ dysfunction/failure Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration Receipt of any experimental treatment for COVID-19 (off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation Any excluded concomitant medication as described in the ARAKODA package insert [Section 16.1]. Receipt of a COVID-19 vaccine is not exclusionary. Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment Positive pregnancy test Have been symptomatic for more than seven days when the first dose would be administered

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tafenoquine<br>Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10 | Drug: Tafenoquine Oral Tablet<br>* Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.<br>* Other names: KODATEF™;|
| Placebo Comparator: Placebo<br>Placebo two tablets 1x/day on Days 1,2,3 and 10 | Drug: Placebo<br>* Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical recovery of COVID-19 symptoms on Day 14 |  | Day 14 [± 1 day] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increases the proportion of patients with absence of clinical symptoms by individual symptom at Day 14 |  | Day 14 [± 1 day] | 
| Decreases the hospitalization rate due to COVID-19 by Day 14 |  | Day 14 [± 1 day] | 
| Decreases the number of medical follow-up visits by Day 14. |  | Day 14 [± 1 day] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate COVID 19 disease, SARS-CoV-2, infectious disease, severe acute respiratory syndrome coronavirus 2