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Tafenoquine in Patients With Mild to Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04533347
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
60 Degrees Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
COVID 19 Disease Drug: Tafenoquine Oral Tablet Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 19, 2021
Estimated Primary Completion Date : June 8, 2021
Estimated Study Completion Date : June 22, 2021


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.




Primary Outcome Measures :
  1. Proportion of patients with clinical recovery of COVID-19 symptoms on Day 14 [ Time Frame: Day 14 [± 1 day] ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 5 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]
  • 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 five days when the first dose would be administered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533347


Contacts
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Contact: Geoffrey Dow, PhD 202-327-5422 geoffdow@60degreespharma.com

Locations
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United States, Texas
Clinical Trial Network Recruiting
Houston, Texas, United States, 77074
Contact: Alan Reichman, M.D.         
Sponsors and Collaborators
60 Degrees Pharmaceuticals LLC
Publications of Results:
Dow GS, Luttick A, Fenner J, Wesche D, Yeo KR, Rayner C. Tafenoquine inhibits replication of SARS-Cov-2 at pharmacologically relevant concentrations in vitro. bioRxiv. January 2020:2020.07.12.199059. doi:10.1101/2020.07.12.199059
Worldometer. Coronavirus Update (Live). https://www.worldometers.info/coronavirus/. Accessed March 7, 2020.

Other Publications:
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Responsible Party: 60 Degrees Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT04533347    
Other Study ID Numbers: TQ 2020_06
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 60 Degrees Pharmaceuticals LLC:
mild to moderate COVID 19 disease
SARS-CoV-2
infectious disease
severe acute respiratory syndrome coronavirus 2
Additional relevant MeSH terms:
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Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents