Tafenoquine in Patients With Mild to Moderate COVID-19

December 13, 2024 updated by: 60 Degrees Pharmaceuticals LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33185
        • Kendall South Medical Center, Inc.
      • Miami, Florida, United States, 33165
        • Hope Clinical Trials
      • Miami, Florida, United States, 33184
        • F&T Medical Research, Inc.
      • Miami, Florida, United States, 33014
        • Deluxe Health Center LLC
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Skyline Medical Center
    • North Carolina
      • Morgantown, North Carolina, United States, 28655
        • Burke Primary Care
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • AFC Urgent Care
    • Texas
      • Brownsville, Texas, United States, 78526
        • Centex Studies
      • Forney, Texas, United States, 75126
        • Care United
      • Houston, Texas, United States, 77074
        • Clinical Trial Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tafenoquine
Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10
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 Names:
  • ARAKODA™
  • KODATEF™
Placebo Comparator: Placebo
Placebo two tablets 1x/day 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
Time Frame: Day 14 [± 1 day]
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.
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
Time Frame: Day 14 [± 1 day]
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)
Day 14 [± 1 day]
Decreases the Hospitalization Rate Due to COVID-19 by Day 14
Time Frame: Day 14 [± 1 day]
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)
Day 14 [± 1 day]
Decreases the Number of Medical Follow-up Visits by Day 14.
Time Frame: Day 14 [± 1 day]
Number and Percentage of Patients by Number of Medical Follow-up Visits (Doctor/ER Visit)
Day 14 [± 1 day]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Planned Interim Analysis and Data Monitoring
Time Frame: 100 patients randomized
Binding futility analysis of primary endpoint will be performed a minimum of 3 weeks after the earlier of [i] 100 pts. randomized or [ii] 6 months has elapsed since randomization of the first pt. in the study. Objective is to determine if tafenoquine increases the proportion of pts. with clinical recovery from COVID-19 symptoms on Day 14 in pts. with mild/moderate COVID-19 disease compared with placebo. Enrolment may be paused by sponsor prior to futility analysis if total number of pts. randomized reaches n=100 and re-initiated by sponsor after completion of futility analysis, if continuing study is determined to be non-futile. Unblinded interim analysis will be conducted by DMC statistician and results will be presented to DMC. If conditional power is less than the predetermined threshold, DMC will recommend terminating enrollment. Sponsor and study team will remain blinded, but will curtail enrollment based on recommendation of the DMC.
100 patients randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

60 Degrees Pharmaceuticals LLC

Investigators

  • Study Director: Akila Chandrasekar, MD, Peachtree BioResearch Solutions Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ 2020_06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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