Trial Outcomes & Findings for Pre-exposure Prophylaxis for SARS-Coronavirus-2 (NCT NCT04328467)
NCT ID: NCT04328467
Last Updated: 2021-07-02
Results Overview
Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1483 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2021-07-02
Participant Flow
Participant milestones
| Measure |
Intervention Once Weekly
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Overall Study
STARTED
|
494
|
495
|
494
|
|
Overall Study
COMPLETED
|
490
|
493
|
493
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
Intervention Once Weekly
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Overall Study
Did not meet inclusion criteria after randomization
|
4
|
2
|
1
|
Baseline Characteristics
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Baseline characteristics by cohort
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
Total
n=1483 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
41 years
n=7 Participants
|
40 years
n=5 Participants
|
41 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
261 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
760 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
723 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
431 Participants
n=5 Participants
|
421 Participants
n=7 Participants
|
419 Participants
n=5 Participants
|
1271 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black of African
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
493 participants
n=5 Participants
|
494 participants
n=7 Participants
|
493 participants
n=5 Participants
|
1480 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksOutcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
COVID-19-free Survival
|
464 Participants
|
468 Participants
|
454 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Number of Confirmed SARS-CoV-2 Detection
|
29 Participants
|
29 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Incidence of Possible COVID-19 Symptoms
|
29 Participants
|
28 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Incidence of All-cause Study Medicine Discontinuation
|
119 Participants
|
158 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Measure was only collected for one participant in the twice-weekly intervention group and one participant in the control group. No participants in the once-weekly intervention group were sampled for this measure.
Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Intervention Once Weekly
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=1 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=1 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End
|
—
|
1 score on a scale
Standard Deviation NA
Only one data point was collected, therefore a measure of dispersion could not be calculated.
|
1 score on a scale
Standard Deviation NA
Only one data point was collected, therefore a measure of dispersion could not be calculated.
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Incidence of Hospitalization for COVID-19 or Death
|
3 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.
Outcome measures
| Measure |
Intervention Once Weekly
n=494 Participants
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 Participants
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 Participants
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Incidence of Possible Study Medication-related Side Effects
|
148 Participants
|
168 Participants
|
100 Participants
|
Adverse Events
Intervention Once Weekly
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Twice Weekly
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Once Weekly
n=494 participants at risk
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Intervention Twice Weekly
n=495 participants at risk
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
Hydroxychloroquine: Hydroxychloroquine; 200mg tablet; oral
|
Control Group
n=494 participants at risk
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
Placebo: Placebo; tablet; oral
|
|---|---|---|---|
|
Surgical and medical procedures
Hysteroscopy
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Surgical and medical procedures
Spinal Surgery
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Surgical and medical procedures
Elective Coronary Angiogram
|
0.00%
0/494 • up to 12 weeks
|
0.20%
1/495 • Number of events 1 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Surgical and medical procedures
Gall Bladder Surgery
|
0.00%
0/494 • up to 12 weeks
|
0.20%
1/495 • Number of events 1 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/494 • up to 12 weeks
|
0.20%
1/495 • Number of events 1 • up to 12 weeks
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/494 • up to 12 weeks
|
0.20%
1/495 • Number of events 1 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.40%
2/494 • Number of events 2 • up to 12 weeks
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.40%
2/494 • Number of events 2 • up to 12 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
|
Endocrine disorders
Hyperthyroid
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.40%
2/494 • Number of events 2 • up to 12 weeks
|
|
Surgical and medical procedures
Sarcoidosis Biopsy
|
0.00%
0/494 • up to 12 weeks
|
0.00%
0/495 • up to 12 weeks
|
0.20%
1/494 • Number of events 1 • up to 12 weeks
|
|
General disorders
Other Not Specified
|
0.00%
0/494 • up to 12 weeks
|
0.40%
2/495 • Number of events 2 • up to 12 weeks
|
0.00%
0/494 • up to 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place