Pre-exposure Prophylaxis for SARS-Coronavirus-2
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ClinicalTrials.gov Identifier: NCT04328467 |
Recruitment Status :
Completed
First Posted : March 31, 2020
Results First Posted : June 30, 2021
Last Update Posted : July 2, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome |
Interventions |
Drug: Hydroxychloroquine Other: Placebo |
Enrollment | 1483 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Intervention Once Weekly | Intervention Twice Weekly | Control Group |
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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 |
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 |
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 |
Period Title: Overall Study | |||
Started | 494 | 495 | 494 |
Completed | 490 | 493 | 493 |
Not Completed | 4 | 2 | 1 |
Reason Not Completed | |||
Did not meet inclusion criteria after randomization | 4 | 2 | 1 |
Arm/Group Title | Intervention Once Weekly | Intervention Twice Weekly | Control Group | Total | |
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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 |
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 |
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 of all reporting groups | |
Overall Number of Baseline Participants | 494 | 495 | 494 | 1483 | |
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[Not Specified]
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Age, Continuous
Mean (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 494 participants | 495 participants | 494 participants | 1483 participants | |
42
(35 to 49)
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41
(35 to 49)
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40
(34 to 48)
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41
(35 to 48)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 494 participants | 495 participants | 494 participants | 1483 participants | |
Female |
261 52.8%
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258 52.1%
|
241 48.8%
|
760 51.2%
|
|
Male |
233 47.2%
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237 47.9%
|
253 51.2%
|
723 48.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 494 participants | 495 participants | 494 participants | 1483 participants |
White or Caucasian |
431 87.2%
|
421 85.1%
|
419 84.8%
|
1271 85.7%
|
|
Black of African |
5 1.0%
|
5 1.0%
|
10 2.0%
|
20 1.3%
|
|
Asian |
23 4.7%
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23 4.6%
|
29 5.9%
|
75 5.1%
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|
Native Hawaiian or Pacific Islander |
0 0.0%
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1 0.2%
|
1 0.2%
|
2 0.1%
|
|
Hispanic or Latino |
18 3.6%
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22 4.4%
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18 3.6%
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58 3.9%
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|
Native American or Alaska Native |
4 0.8%
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7 1.4%
|
8 1.6%
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19 1.3%
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Middle Eastern |
6 1.2%
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5 1.0%
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4 0.8%
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15 1.0%
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|
South Asian |
17 3.4%
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18 3.6%
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12 2.4%
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47 3.2%
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Other |
3 0.6%
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1 0.2%
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4 0.8%
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8 0.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 494 participants | 495 participants | 494 participants | 1483 participants |
United States | 493 | 494 | 493 | 1480 | |
Canada | 1 | 1 | 1 | 3 |
Name/Title: | Radha Rajasingham, MD |
Organization: | University of Minnesota |
Phone: | 612-626-8171 |
EMail: | radha@umn.edu |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT04328467 |
Other Study ID Numbers: |
MED-2020-28720 |
First Submitted: | March 27, 2020 |
First Posted: | March 31, 2020 |
Results First Submitted: | June 25, 2021 |
Results First Posted: | June 30, 2021 |
Last Update Posted: | July 2, 2021 |