Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
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ClinicalTrials.gov Identifier: NCT04328961 |
Recruitment Status :
Completed
First Posted : April 1, 2020
Results First Posted : December 16, 2021
Last Update Posted : December 16, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Conditions |
COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2 |
Interventions |
Drug: Hydroxychloroquine Sulfate Drug: Ascorbic Acid |
Enrollment | 943 |
Recruitment Details | |
Pre-assignment Details | 949 participants were assessed for eligibility, 114 were excluded and 829 were randomized. |
Arm/Group Title | Ascorbic Acid | Hydroxychloroquine |
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Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. |
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy |
Period Title: Overall Study | ||
Started | 422 | 407 |
Completed | 336 | 353 |
Not Completed | 86 | 54 |
Arm/Group Title | Ascorbic Acid | Hydroxychloroquine | Total | |
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Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy. |
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy |
Total of all reporting groups | |
Overall Number of Baseline Participants | 336 | 353 | 689 | |
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The above participants contributed to the Modified Intention-to-Treat Cohort.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 336 participants | 353 participants | 689 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
307 91.4%
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322 91.2%
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629 91.3%
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>=65 years |
29 8.6%
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31 8.8%
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60 8.7%
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 336 participants | 353 participants | 689 participants | |
38
(26 to 50)
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40
(27 to 51)
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39
(27 to 51)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 336 participants | 353 participants | 689 participants | |
Female |
197 58.6%
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215 60.9%
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412 59.8%
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Male |
139 41.4%
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138 39.1%
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277 40.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 336 participants | 353 participants | 689 participants | |
Hispanic or Latino |
86 25.6%
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69 19.5%
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155 22.5%
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Not Hispanic or Latino |
250 74.4%
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284 80.5%
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534 77.5%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 336 participants | 353 participants | 689 participants | |
American Indian or Alaska Native |
5 1.5%
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7 2.0%
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12 1.7%
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Asian |
43 12.8%
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30 8.5%
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73 10.6%
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Native Hawaiian or Other Pacific Islander |
1 0.3%
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1 0.3%
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2 0.3%
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Black or African American |
34 10.1%
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20 5.7%
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54 7.8%
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White |
160 47.6%
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209 59.2%
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369 53.6%
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More than one race |
86 25.6%
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69 19.5%
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155 22.5%
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Unknown or Not Reported |
7 2.1%
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17 4.8%
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24 3.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 336 participants | 353 participants | 689 participants |
336 | 353 | 689 |
Name/Title: | Ruanne Barnabas |
Organization: | University of Washington |
Phone: | 206 520 3800 |
EMail: | rbarnaba@uw.edu |
Responsible Party: | Ruanne Barnabas, University of Washington |
ClinicalTrials.gov Identifier: | NCT04328961 |
Other Study ID Numbers: |
STUDY00009750 INV-016204 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation ) |
First Submitted: | March 23, 2020 |
First Posted: | April 1, 2020 |
Results First Submitted: | October 8, 2021 |
Results First Posted: | December 16, 2021 |
Last Update Posted: | December 16, 2021 |