Tafenoquine in Patients With Mild to Moderate COVID-19

NCT04533347 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TQ 2020_06
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID 19 Disease

Keywords

mild to moderate COVID 19 disease; SARS-CoV-2; infectious disease; severe acute respiratory syndrome coronavirus 2

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 14 [± 1 day]

Secondary Outcomes (3)

• 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]

Other Outcomes (1)

• Planned Interim Analysis and Data Monitoring

  100 patients randomized

Study Arms (2)

Tafenoquine

ACTIVE COMPARATOR

Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10

Drug: Tafenoquine Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo two tablets 1x/day on Days 1,2,3 and 10

Drug: Placebo

Interventions

Tafenoquine Oral Tablet DRUG

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.

Also known as: ARAKODA™, KODATEF™

Tafenoquine

Placebo DRUG

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• 60 Degrees Pharmaceuticals LLC: lead

Study Sites (10)

Deluxe Health Center LLC

Miami, Florida, 33014, United States

Location

Hope Clinical Trials

Miami, Florida, 33165, United States

Location

F&T Medical Research, Inc.

Miami, Florida, 33184, United States

Location

Kendall South Medical Center, Inc.

Miami, Florida, 33185, United States

Location

Skyline Medical Center

Elkhorn, Nebraska, 68022, United States

Location

Burke Primary Care

Morgantown, North Carolina, 28655, United States

Location

AFC Urgent Care

Easley, South Carolina, 29640, United States

Location

Centex Studies

Brownsville, Texas, 78526, United States

Location

Care United

Forney, Texas, 75126, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Related Publications (13)

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MeSH Terms

Conditions

Communicable Diseases

Interventions

tafenoquine

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bernadette Tock
• Organization: Fast-Track Drugs and Biologics, LLC

btock@fasttrackresearch.com

240-401-8634

Study Officials

• Akila Chandrasekar, MD

  Peachtree BioResearch Solutions Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: August 31, 2020
• Study Start: February 19, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)