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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
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 494 participants 495 participants 494 participants 1483 participants
42
(35 to 49)
41
(35 to 49)
40
(34 to 48)
41
(35 to 48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 494 participants 495 participants 494 participants 1483 participants
Female
261
  52.8%
258
  52.1%
241
  48.8%
760
  51.2%
Male
233
  47.2%
237
  47.9%
253
  51.2%
723
  48.8%
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%
23
   4.6%
29
   5.9%
75
   5.1%
Native Hawaiian or Pacific Islander
0
   0.0%
1
   0.2%
1
   0.2%
2
   0.1%
Hispanic or Latino
18
   3.6%
22
   4.4%
18
   3.6%
58
   3.9%
Native American or Alaska Native
4
   0.8%
7
   1.4%
8
   1.6%
19
   1.3%
Middle Eastern
6
   1.2%
5
   1.0%
4
   0.8%
15
   1.0%
South Asian
17
   3.4%
18
   3.6%
12
   2.4%
47
   3.2%
Other
3
   0.6%
1
   0.2%
4
   0.8%
8
   0.5%
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
1.Primary Outcome
Title COVID-19-free Survival
Hide Description Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
464
  93.9%
468
  94.5%
454
  91.9%
2.Secondary Outcome
Title Number of Confirmed SARS-CoV-2 Detection
Hide Description Outcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
29
   5.9%
29
   5.9%
39
   7.9%
3.Secondary Outcome
Title Incidence of Possible COVID-19 Symptoms
Hide Description Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
29
   5.9%
28
   5.7%
38
   7.7%
4.Secondary Outcome
Title Incidence of All-cause Study Medicine Discontinuation
Hide Description Outcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
119
  24.1%
158
  31.9%
133
  26.9%
5.Secondary Outcome
Title Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End
Hide Description 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.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0 1 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
1 [1]   (NA) 1 [1]   (NA)
[1]
Only one data point was collected, therefore a measure of dispersion could not be calculated.
6.Secondary Outcome
Title Incidence of Hospitalization for COVID-19 or Death
Hide Description Outcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.6%
8
   1.6%
9
   1.8%
7.Secondary Outcome
Title Incidence of Possible Study Medication-related Side Effects
Hide Description Outcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 494 495 494
Measure Type: Count of Participants
Unit of Measure: Participants
148
  30.0%
168
  33.9%
100
  20.2%
Time Frame up to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Once Weekly Intervention Twice Weekly Control Group
Hide Arm/Group Description

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

All-Cause Mortality
Intervention Once Weekly Intervention Twice Weekly Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/494 (0.00%)      0/495 (0.00%)      0/494 (0.00%)    
Hide Serious Adverse Events
Intervention Once Weekly Intervention Twice Weekly Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/494 (0.61%)      6/495 (1.21%)      8/494 (1.62%)    
Cardiac disorders       
Chest Pain   0/494 (0.00%)  0 0/495 (0.00%)  0 2/494 (0.40%)  2
Heart Palpitations   0/494 (0.00%)  0 0/495 (0.00%)  0 2/494 (0.40%)  2
Tachycardia   0/494 (0.00%)  0 0/495 (0.00%)  0 1/494 (0.20%)  1
Atrial Fibrillation   0/494 (0.00%)  0 0/495 (0.00%)  0 2/494 (0.40%)  2
Endocrine disorders       
Hyperthyroid   0/494 (0.00%)  0 0/495 (0.00%)  0 1/494 (0.20%)  1
Gastrointestinal disorders       
Diverticulitis   1/494 (0.20%)  1 0/495 (0.00%)  0 0/494 (0.00%)  0
General disorders       
Other Not Specified   0/494 (0.00%)  0 2/495 (0.40%)  2 0/494 (0.00%)  0
Injury, poisoning and procedural complications       
Motor Vehicle Accident   0/494 (0.00%)  0 1/495 (0.20%)  1 0/494 (0.00%)  0
Renal and urinary disorders       
Urinary Tract Infection   0/494 (0.00%)  0 1/495 (0.20%)  1 1/494 (0.20%)  1
Surgical and medical procedures       
Hysteroscopy   1/494 (0.20%)  1 0/495 (0.00%)  0 0/494 (0.00%)  0
Spinal Surgery   1/494 (0.20%)  1 0/495 (0.00%)  0 0/494 (0.00%)  0
Elective Coronary Angiogram   0/494 (0.00%)  0 1/495 (0.20%)  1 0/494 (0.00%)  0
Gall Bladder Surgery   0/494 (0.00%)  0 1/495 (0.20%)  1 0/494 (0.00%)  0
Sarcoidosis Biopsy   0/494 (0.00%)  0 0/495 (0.00%)  0 1/494 (0.20%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Once Weekly Intervention Twice Weekly Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/494 (0.00%)      0/495 (0.00%)      0/494 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Radha Rajasingham, MD
Organization: University of Minnesota
Phone: 612-626-8171
EMail: radha@umn.edu
Layout table for additonal information
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