Tafenoquine in Patients With Mild to Moderate COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04533347 |
Recruitment Status :
Completed
First Posted : August 31, 2020
Last Update Posted : January 17, 2023
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Condition or disease | Intervention/treatment | Phase |
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COVID 19 Disease | Drug: Tafenoquine Oral Tablet Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 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 |
Actual Study Start Date : | February 19, 2021 |
Actual Primary Completion Date : | June 30, 2022 |
Actual Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
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Active Comparator: Tafenoquine
Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10
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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:
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Placebo Comparator: Placebo
Placebo two tablets 1x/day on Days 1,2,3 and 10
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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. |
- Proportion of patients with clinical recovery of COVID-19 symptoms on Day 14 [ Time Frame: Day 14 [± 1 day] ]
- Increases the proportion of patients with absence of clinical symptoms by individual symptom at Day 14 [ Time Frame: Day 14 [± 1 day] ]
- Decreases the hospitalization rate due to COVID-19 by Day 14 [ Time Frame: Day 14 [± 1 day] ]
- Decreases the number of medical follow-up visits by Day 14. [ Time Frame: Day 14 [± 1 day] ]
- 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.

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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.
Exclusion Criteria:
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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
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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 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

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
United States, Florida | |
Deluxe Health Center LLC | |
Miami, Florida, United States, 33014 | |
Hope Clinical Trials | |
Miami, Florida, United States, 33165 | |
F&T Medical Research, Inc. | |
Miami, Florida, United States, 33184 | |
Kendall South Medical Center, Inc. | |
Miami, Florida, United States, 33185 | |
United States, Nebraska | |
Skyline Medical Center | |
Elkhorn, Nebraska, United States, 68022 | |
United States, North Carolina | |
Burke Primary Care | |
Morgantown, North Carolina, United States, 28655 | |
United States, South Carolina | |
AFC Urgent Care | |
Easley, South Carolina, United States, 29640 | |
United States, Texas | |
Centex Studies | |
Brownsville, Texas, United States, 78526 | |
Care United | |
Forney, Texas, United States, 75126 | |
Clinical Trial Network | |
Houston, Texas, United States, 77074 |
Other Publications:
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: | January 17, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mild to moderate COVID 19 disease SARS-CoV-2 infectious disease severe acute respiratory syndrome coronavirus 2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Tafenoquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |