COVID 19 Disease
Conditions
Keywords
mild to moderate COVID 19 disease, SARS-CoV-2, infectious disease, severe acute respiratory syndrome coronavirus 2
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.
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.
Interventions
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
DRUGPlacebo
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
Sponsors
60 Degrees Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | 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) |
| Decreases the Hospitalization Rate Due to COVID-19 by Day 14 | 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) |
| Decreases the Number of Medical Follow-up Visits by Day 14. | Day 14 [± 1 day] | Number and Percentage of Patients by Number of Medical Follow-up Visits (Doctor/ER Visit) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Planned Interim Analysis and Data Monitoring | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tafenoquine Tafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10
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. | 45 |
| Placebo Placebo two tablets 1x/day on Days 1,2,3 and 10
Placebo: Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10. | 41 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tafenoquine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 14.67 | 42.6 years STANDARD_DEVIATION 14.63 | 42.5 years STANDARD_DEVIATION 14.76 |
| Age, Customized < 40 years old | 20 Participants | 37 Participants | 17 Participants |
| Age, Customized >= 40 years old | 25 Participants | 49 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 65 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 21 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.9 centimeters STANDARD_DEVIATION 10.6 | 167.5 centimeters STANDARD_DEVIATION 10.67 | 167.6 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 84 Participants | 41 Participants |
| Region of Enrollment United States | 45 participants | 86 participants | 41 participants |
| Sex: Female, Male Female | 24 Participants | 45 Participants | 21 Participants |
| Sex: Female, Male Male | 21 Participants | 41 Participants | 20 Participants |
| Weight | 81.0 kilograms | 82.3 kilograms | 86.2 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 41 |
| other Total, other adverse events | 8 / 45 | 4 / 41 |
| serious Total, serious adverse events | 1 / 45 | 2 / 41 |
Outcome results
Primary
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.
Time frame: Day 14 [± 1 day]
Population: Intention-to-treat population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafenoquine | Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14 | Not Recovered | 8 Participants |
| Tafenoquine | Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14 | Recovered | 37 Participants |
| Placebo | Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14 | Not Recovered | 10 Participants |
| Placebo | Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14 | Recovered | 31 Participants |
Comparison: Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.p-value: 0.1879Fisher Exact
Secondary
Decreases the Hospitalization Rate Due to COVID-19 by Day 14
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)
Time frame: Day 14 [± 1 day]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafenoquine | Decreases the Hospitalization Rate Due to COVID-19 by Day 14 | 1 Participants |
| Placebo | Decreases the Hospitalization Rate Due to COVID-19 by Day 14 | 2 Participants |
Secondary
Decreases the Number of Medical Follow-up Visits by Day 14.
Number and Percentage of Patients by Number of Medical Follow-up Visits (Doctor/ER Visit)
Time frame: Day 14 [± 1 day]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 1 | 2 Participants |
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 3 | 0 Participants |
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 0 | 42 Participants |
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 2 | 1 Participants |
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits >=4 | 0 Participants |
| Tafenoquine | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 4 | 0 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits >=4 | 0 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 0 | 39 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 1 | 1 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 2 | 1 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 3 | 0 Participants |
| Placebo | Decreases the Number of Medical Follow-up Visits by Day 14. | Number of Doctor/ER Visits = 4 | 0 Participants |
Secondary
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
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)
Time frame: Day 14 [± 1 day]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - None | 42 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Mild | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - None | 38 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - None | 41 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - None | 31 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Mild | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Mild | 2 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Mild | 9 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Mild | 4 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Moderate | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - None | 41 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Severe | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Mild | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Moderate | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - None | 37 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? I did not vomit at all | 42 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Moderate | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 1-2 times | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Mild | 5 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 3-4 times | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 5 or more times | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Moderate | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? Not done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? I did not have diarrhea at all | 39 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 1-2 times | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 3-4 times | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Not Done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 5 or more times | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Mild | 6 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? Not done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - None | 34 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - My sense of smell is the same as usual | 19 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - None | 34 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - My sense of smell is less than usual | 18 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Mild | 6 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - I have no sense of smell | 5 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Severe | 0 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - Not done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Moderate | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - My sense of taste is the same as usual | 20 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Mild | 8 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - My sense of taste is less than usual | 19 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Severe | 1 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - I have no sense of taste | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - None | 39 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - Not done | 3 Participants |
| Tafenoquine | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - None | 35 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - Not done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - None | 31 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Mild | 6 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Moderate | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Stuffy or Runny Nose - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - None | 37 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Mild | 1 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Moderate | 1 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Moderate | 3 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Sore Throat - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - None | 32 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Mild | 6 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Moderate | 1 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Shortness of Breath - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - None | 25 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Mild | 11 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Moderate | 3 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Cough - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - None | 21 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Mild | 14 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Severe | 1 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Low Energy or Tiredness - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - None | 32 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Mild | 7 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Moderate | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Muscle or Body Aches - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - None | 33 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Mild | 5 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Moderate | 1 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Headache - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - None | 39 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Mild | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Moderate | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Chills or Shivering - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - None | 39 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Mild | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Moderate | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Feeling Hot or Feverish - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - None | 39 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Mild | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Moderate | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Severe | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Nausea - Not Done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? I did not vomit at all | 39 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 1-2 times | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 3-4 times | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? 5 or more times | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you vomit in the last 24 hours? Not done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? I did not have diarrhea at all | 37 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 1-2 times | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 3-4 times | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? 5 or more times | 0 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | How many times did you have diarrhea in the last 24 hours? Not done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - My sense of smell is the same as usual | 17 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - My sense of smell is less than usual | 19 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - I have no sense of smell | 3 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of smell in the last 24 hours - Not done | 2 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - My sense of taste is the same as usual | 15 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - My sense of taste is less than usual | 21 Participants |
| Placebo | Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14 | Rate your sense of taste in the last 24 hours - I have no sense of taste | 3 Participants |
Other Pre-specified
Planned Interim Analysis and Data Monitoring
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.
Time frame: 100 patients randomized