Clinical trial NCT04533347: Tafenoquine in Patients With Mild to Moderate COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID 19 Disease
Keywords: mild to moderate COVID 19 disease
SARS-CoV-2
infectious disease
severe acute respiratory syndrome coronavirus 2
Lead sponsor: 60 Degrees Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
timeFrame: Day 14 [± 1 day]
Secondary outcomes:
measure: Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
timeFrame: Day 14 [± 1 day]
measure: Decreases the Hospitalization Rate Due to COVID-19 by Day 14
timeFrame: Day 14 [± 1 day]
measure: Decreases the Number of Medical Follow-up Visits by Day 14.
timeFrame: Day 14 [± 1 day]
Other outcomes:
measure: Planned Interim Analysis and Data Monitoring
timeFrame: 100 patients randomized
Locations:
city: Miami
country: United States
facility: Deluxe Health Center LLC
state: Florida
city: Miami
country: United States
facility: Hope Clinical Trials
state: Florida
city: Miami
country: United States
facility: F&T Medical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Elkhorn
country: United States
facility: Skyline Medical Center
state: Nebraska
city: Morgantown
country: United States
facility: Burke Primary Care
state: North Carolina
city: Easley
country: United States
facility: AFC Urgent Care
state: South Carolina
city: Brownsville
country: United States
facility: Centex Studies
state: Texas
city: Forney
country: United States
facility: Care United
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
Study officials:
affiliation: Peachtree BioResearch Solutions Inc.
name: Akila Chandrasekar, MD
role: STUDY_DIRECTOR
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