Trial Outcomes & Findings for Tafenoquine in Patients With Mild to Moderate COVID-19 (NCT NCT04533347)
NCT ID: NCT04533347
Last Updated: 2025-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Day 14 [± 1 day]
Results posted on
2025-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
41
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Tafenoquine in Patients With Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Tafenoquine
n=45 Participants
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.
|
Placebo
n=41 Participants
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.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 14.67 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 14.76 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 14.63 • n=5 Participants
|
|
Age, Customized
< 40 years old
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
>= 40 years old
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
41 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Height
|
167.6 centimeters
n=5 Participants
|
167.6 centimeters
n=7 Participants
|
167.6 centimeters
n=5 Participants
|
|
Weight
|
81.0 kilograms
n=5 Participants
|
86.2 kilograms
n=7 Participants
|
82.3 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 [± 1 day]Population: Intention-to-treat population
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.
Outcome measures
| Measure |
Tafenoquine
n=45 Participants
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.
|
Placebo
n=41 Participants
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.
|
|---|---|---|
|
Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
Not Recovered
|
8 Participants
|
10 Participants
|
|
Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
Recovered
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Tafenoquine
n=45 Participants
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.
|
Placebo
n=41 Participants
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.
|
|---|---|---|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Stuffy or Runny Nose - None
|
35 Participants
|
31 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Stuffy or Runny Nose - Mild
|
6 Participants
|
6 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Stuffy or Runny Nose - Moderate
|
1 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Stuffy or Runny Nose - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Stuffy or Runny Nose - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Sore Throat - None
|
39 Participants
|
37 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Sore Throat - Mild
|
2 Participants
|
1 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Sore Throat - Moderate
|
1 Participants
|
1 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Sore Throat - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Sore Throat - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Shortness of Breath - None
|
38 Participants
|
32 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Shortness of Breath - Mild
|
4 Participants
|
6 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Shortness of Breath - Moderate
|
0 Participants
|
1 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Shortness of Breath - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Shortness of Breath - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Cough - None
|
34 Participants
|
25 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Cough - Mild
|
8 Participants
|
11 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Cough - Moderate
|
0 Participants
|
3 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Cough - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Cough - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Low Energy or Tiredness - None
|
31 Participants
|
21 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Low Energy or Tiredness - Mild
|
9 Participants
|
14 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Low Energy or Tiredness - Moderate
|
1 Participants
|
3 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Low Energy or Tiredness - Severe
|
1 Participants
|
1 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Low Energy or Tiredness - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Muscle or Body Aches - None
|
37 Participants
|
32 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Muscle or Body Aches - Mild
|
5 Participants
|
7 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Muscle or Body Aches - Moderate
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Muscle or Body Aches - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Muscle or Body Aches - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Headache - None
|
34 Participants
|
33 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Headache - Mild
|
6 Participants
|
5 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Headache - Moderate
|
1 Participants
|
1 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Headache - Severe
|
1 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Headache - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Chills or Shivering - None
|
42 Participants
|
39 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Chills or Shivering - Mild
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Chills or Shivering - Moderate
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Chills or Shivering - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Chills or Shivering - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Feeling Hot or Feverish - None
|
41 Participants
|
39 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Feeling Hot or Feverish - Mild
|
1 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Feeling Hot or Feverish - Moderate
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Feeling Hot or Feverish - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Feeling Hot or Feverish - Not Done
|
3 Participants
|
2 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Nausea - None
|
41 Participants
|
39 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Nausea - Mild
|
1 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Nausea - Moderate
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Nausea - Severe
|
0 Participants
|
0 Participants
|
|
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Nausea - Not Done
|
3 Participants
|
2 Participants
|
|
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
|
39 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
2 Participants
|
|
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
|
37 Participants
|
|
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
|
2 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
2 Participants
|
|
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
|
17 Participants
|
|
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
|
19 Participants
|
|
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
|
3 Participants
|
|
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
|
2 Participants
|
|
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
|
15 Participants
|
|
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
|
21 Participants
|
|
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
|
3 Participants
|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Tafenoquine
n=45 Participants
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.
|
Placebo
n=41 Participants
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.
|
|---|---|---|
|
Decreases the Hospitalization Rate Due to COVID-19 by Day 14
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 14 [± 1 day]Number and Percentage of Patients by Number of Medical Follow-up Visits (Doctor/ER Visit)
Outcome measures
| Measure |
Tafenoquine
n=45 Participants
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.
|
Placebo
n=41 Participants
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.
|
|---|---|---|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits = 0
|
42 Participants
|
39 Participants
|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits = 1
|
2 Participants
|
1 Participants
|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits = 2
|
1 Participants
|
1 Participants
|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits = 3
|
0 Participants
|
0 Participants
|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits = 4
|
0 Participants
|
0 Participants
|
|
Decreases the Number of Medical Follow-up Visits by Day 14.
Number of Doctor/ER Visits >=4
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 100 patients randomizedBinding 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.
Outcome measures
Outcome data not reported
Adverse Events
Tafenoquine
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tafenoquine
n=45 participants at risk
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.
|
Placebo
n=41 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
2.2%
1/45 • 28 days +/- 1 day
|
4.9%
2/41 • 28 days +/- 1 day
|
Other adverse events
| Measure |
Tafenoquine
n=45 participants at risk
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.
|
Placebo
n=41 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Investigations
Transaminases increased
|
2.2%
1/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Investigations
Haematocrit decreased
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Investigations
Haemoglobin decreased
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Investigations
Red blood cell count decreased
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Nervous system disorders
Syncope
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
|
Psychiatric disorders
Panic attack
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • 28 days +/- 1 day
|
0.00%
0/41 • 28 days +/- 1 day
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/45 • 28 days +/- 1 day
|
2.4%
1/41 • 28 days +/- 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place