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Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328961
Recruitment Status : Completed
First Posted : April 1, 2020
Results First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
The above participants contributed to the Modified Intention-to-Treat Cohort.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 353 participants 689 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
307
  91.4%
322
  91.2%
629
  91.3%
>=65 years
29
   8.6%
31
   8.8%
60
   8.7%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 336 participants 353 participants 689 participants
38
(26 to 50)
40
(27 to 51)
39
(27 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 353 participants 689 participants
Female
197
  58.6%
215
  60.9%
412
  59.8%
Male
139
  41.4%
138
  39.1%
277
  40.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 353 participants 689 participants
Hispanic or Latino
86
  25.6%
69
  19.5%
155
  22.5%
Not Hispanic or Latino
250
  74.4%
284
  80.5%
534
  77.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 353 participants 689 participants
American Indian or Alaska Native
5
   1.5%
7
   2.0%
12
   1.7%
Asian
43
  12.8%
30
   8.5%
73
  10.6%
Native Hawaiian or Other Pacific Islander
1
   0.3%
1
   0.3%
2
   0.3%
Black or African American
34
  10.1%
20
   5.7%
54
   7.8%
White
160
  47.6%
209
  59.2%
369
  53.6%
More than one race
86
  25.6%
69
  19.5%
155
  22.5%
Unknown or Not Reported
7
   2.1%
17
   4.8%
24
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 336 participants 353 participants 689 participants
336 353 689
1.Primary Outcome
Title Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Hide Description Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days
Time Frame Day 1 through Day 14 after enrolment
Hide Outcome Measure Data
Hide Analysis Population Description
The above participants qualified for the Modified Intention-to-Treat Cohort
Arm/Group Title Ascorbic Acid Hydroxychloroquine
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 336 353
Measure Type: Count of Participants
Unit of Measure: Participants
45
  13.4%
53
  15.0%
2.Primary Outcome
Title The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection
Hide Description Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Time Frame Day 28 after enrolment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ascorbic Acid Hydroxychloroquine
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 336 353
Measure Type: Count of Participants
Unit of Measure: Participants
48
  14.3%
58
  16.4%
3.Secondary Outcome
Title Rate of Participant-reported Adverse Events
Hide Description Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Time Frame 28 days from start of Hydroxychloroquine therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ascorbic Acid Hydroxychloroquine
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 336 353
Measure Type: Count of Participants
Unit of Measure: Participants
46
  13.7%
66
  18.7%
4.Secondary Outcome
Title Number of Participants Who Had COVID-19 Disease
Hide Description Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.
Time Frame 28 days from enrolment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ascorbic Acid Hydroxychloroquine
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 336 353
Measure Type: Count of Participants
Unit of Measure: Participants
26
   7.7%
37
  10.5%
Time Frame Adverse event data was collected during the period of follow up, which was 28 days.
Adverse Event Reporting Description Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
 
Arm/Group Title Ascorbic Acid Hydroxychloroquine
Hide Arm/Group Description

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

All-Cause Mortality
Ascorbic Acid Hydroxychloroquine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/422 (0.00%)      0/407 (0.00%)    
Hide Serious Adverse Events
Ascorbic Acid Hydroxychloroquine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/422 (0.47%)      2/407 (0.49%)    
Immune system disorders     
Allergic Reaction *  1/422 (0.24%)  1 1/407 (0.25%)  1
Infections and infestations     
Hospitalizations *  1/422 (0.24%)  1 1/407 (0.25%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ascorbic Acid Hydroxychloroquine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/422 (10.90%)      66/407 (16.22%)    
Ear and labyrinth disorders     
Tinnitus *  0/422 (0.00%)  0 0/407 (0.00%)  0
Eye disorders     
Visual Changes *  0/422 (0.00%)  0 4/407 (0.98%)  4
Gastrointestinal disorders     
Diarrhea, abdominal discomfort, or vomiting *  7/422 (1.66%)  7 25/407 (6.14%)  25
Nausea or upset stomach *  10/422 (2.37%)  10 14/407 (3.44%)  14
General disorders     
Neurologic reaction: irritability, dizziness, or vertifgo *  11/422 (2.61%)  11 6/407 (1.47%)  6
Headache *  7/422 (1.66%)  7 5/407 (1.23%)  5
Hot flashes, night sweats, or palpitations *  6/422 (1.42%)  6 2/407 (0.49%)  2
Taste change or dry mouth *  6/422 (1.42%)  6 1/407 (0.25%)  1
Fatigue *  2/422 (0.47%)  2 4/407 (0.98%)  4
Immune system disorders     
Allergic reaction *  0/422 (0.00%)  0 2/407 (0.49%)  2
Skin and subcutaneous tissue disorders     
Skin reaction/rash *  8/422 (1.90%)  8 11/407 (2.70%)  11
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ruanne Barnabas
Organization: University of Washington
Phone: 206 520 3800
EMail: rbarnaba@uw.edu
Layout table for additonal information
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