A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

NCT ID: NCT05947812

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-27

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 and low risk of disease progression (the "ACLR8-LR" study).

Detailed Description

The TQ 2020_08 study is a double-blind placebo-controlled, Phase 2b clinical trial that plans to enroll approximately 148 non-hospitalized patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study). Patients will undergo a brief screening period before being randomized to receive either self-administered 200 mg tafenoquine or matching placebo for up to 38 days. Following the treatment period, patients will have a follow up visit at study Day 42. The study's primary efficacy endpoint is time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days).

Conditions

COVID 19 Disease; Mild to Moderate COVID 19 Disease; SARS-CoV-2; Infectious Disease; Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tafenoquine

Tafenoquine two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery

Group Type: EXPERIMENTAL

Tafenoquine Oral Tablet

Intervention Type: DRUG

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.

Placebo

Placebo two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.

Interventions

Tafenoquine Oral Tablet

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.

Intervention Type: DRUG

Placebo

Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.

Intervention Type: DRUG

Other Intervention Names

KODATEF™; Arakoda

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged ≥18, regardless of COVID-19 vaccination status;

2. Laboratory confirmed infection COVID-19 disease as determined using an FDA-authorized COVID-19 rapid antigen test;

3. Able and willing to give written informed consent;

4. Willing to complete the following study activities and assessments:

1. Keep an electronic diary from Study Days 2 through 42.

2. Have phone or videoconferences with study team personnel on Study Days 10, 21, and 35.

3. Have study samples collected in-home on Days 5, 14, 28, and 42

4. Agree to return to clinic for additional safety evaluations if needed, as determined by the study team;

5. An aggregate patient-reported COVID-19 symptom score of at ≥3 on the first day of drug administration (Study Day 1).

6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 42 of the study;

7. Able to take ARAKODA according to Prescribing Information

8. Have been symptomatic no longer than 7 days inclusive of Day 1 when the first dose of study medication is administered.

9. 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.

10. Possess a smart phone or tablet, or are willing to utilize a sponsor-provided device if available.

Exclusion Criteria

1. Have any of the contraindications for ARAKODA in the prescribing information including:

1. G6PD deficiency

2. Breastfeeding

3. Psychotic disorder or current psychotic symptoms

4. Known hypersensitivity reaction to TQ

2. 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

3. Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration;

4. Receipt of any approved or experimental small molecule treatment for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation

5. Receipt of any approved or experimental biologic therapeutic for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 90 days prior to the time of the screening evaluation

6. Have been diagnosed (and confirmed by PCR or rapid antigen test) with COVID-19 in the 90 days prior to randomization (other than for this infection);

7. Any excluded concomitant medication as described in the ARAKODA package insert. Receipt of a COVID-19 vaccine is not exclusionary;

8. Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment.

9. Positive pregnancy test;

10. Are ≥65 years of age and have a clinical frailty score > 5;

11. Have cystic fibrosis;

12. Have received a transplant;

13. Known to be infected with human immunodeficiency virus (HIV);

14. Have received any B-Cell depleting monoclonal antibody in the last six months;

15. Have a disease or condition which in the opinion of the investigator presents an unacceptable risk of disease progression;

16. Have an aggregate symptom score ≥ 15 and any one of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, have never been vaccinated for COVID-19, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance;

17. Have two or more of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance;

18. Have an aggregate symptom score >32.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

60P Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Geoff Dow, PhD

Role: CONTACT

geoffdow@60degreespharma.com

202-327-5422

References

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Other Identifiers

TQ 2022-08

Identifier Type: -

Identifier Source: org_study_id