Official Title
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
Brief 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.

Completed
COVID 19 Disease

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.
Other Name: Array

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.

Eligibility Criteria

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:

1. Respiratory rate ≥ 24/min

2. New cough or shortness of breath that has presented within the last 4 days

3. 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:

1. G6PD deficiency

2. Breastfeeding

3. Psychotic disorder or current psychotic symptoms

4. Known hypersensitivity reaction to TQ

- Evidence of severe or critical illness, defined by at least one of the following:

1. 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

2. 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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.
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

60 Degrees Pharmaceuticals LLC
NCT Number
Keywords
mild to moderate COVID 19 disease
SARS-CoV-2
Infectious disease
Severe acute respiratory syndrome coronavirus 2
MeSH Terms
COVID-19
Tafenoquine