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Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)

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ClinicalTrials.gov Identifier: NCT04334148
Recruitment Status : Completed
First Posted : April 6, 2020
Results First Posted : October 7, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition COVID-19
Interventions Drug: Hydroxychloroquine
Drug: Placebo oral tablet
Enrollment 1360
Recruitment Details  
Pre-assignment Details A participant was excluded from analysis population if they had a positive nasal swab test at baseline visit. This occurred to 1 participant assigned to the placebo group.
Arm/Group Title Hydroxychloroquine Placebo
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Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

Period Title: Overall Study
Started 683 677
Completed 683 676
Not Completed 0 1
Reason Not Completed
positive nasal swab at baseline             0             1
Arm/Group Title Hydroxychloroquine Placebo Total
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Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

Total of all reporting groups
Overall Number of Baseline Participants 683 676 1359
Hide Baseline Analysis Population Description
Participants who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 683 participants 676 participants 1359 participants
44.2  (11.9) 43.1  (11.2) 43.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 683 participants 676 participants 1359 participants
Female
442
  64.7%
446
  66.0%
888
  65.3%
Male
241
  35.3%
230
  34.0%
471
  34.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 683 participants 676 participants 1359 participants
Hispanic or Latino
39
   5.7%
40
   5.9%
79
   5.8%
Not Hispanic or Latino
639
  93.6%
629
  93.0%
1268
  93.3%
Unknown or Not Reported
5
   0.7%
7
   1.0%
12
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 683 participants 676 participants 1359 participants
American Indian or Alaska Native
1
   0.1%
2
   0.3%
3
   0.2%
Asian
28
   4.1%
27
   4.0%
55
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.3%
2
   0.1%
Black or African American
18
   2.6%
23
   3.4%
41
   3.0%
White
624
  91.4%
610
  90.2%
1234
  90.8%
More than one race
6
   0.9%
9
   1.3%
15
   1.1%
Unknown or Not Reported
6
   0.9%
3
   0.4%
9
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 683 participants 676 participants 1359 participants
683 676 1359
1.Primary Outcome
Title Number of Participants With Clinical Infection With COVID-19 Infection
Hide Description This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
Time Frame 30 days
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Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Hydroxychloroquine Placebo
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Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

Overall Number of Participants Analyzed 683 676
Measure Type: Count of Participants
Unit of Measure: Participants
41
   6.0%
53
   7.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hydroxychloroquine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With COVID-19 Viral Shedding
Hide Description Number of participants with COVID-19 infection shedding via Covance swab PCR testing
Time Frame 30 days
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Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Hydroxychloroquine Placebo
Hide Arm/Group Description:

Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

Overall Number of Participants Analyzed 683 676
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.3%
2
   0.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hydroxychloroquine, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs)
Hide Description Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Hydroxychloroquine Placebo
Hide Arm/Group Description:

Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

Overall Number of Participants Analyzed 683 676
Measure Type: Count of Participants
Unit of Measure: Participants
7
   1.0%
8
   1.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hydroxychloroquine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.802
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 60 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydroxychloroquine Placebo
Hide Arm/Group Description

Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.

Hydroxychloroquine: oral self administered tablet

Matching placebo tablets

Placebo oral tablet: oral self administered tablet

All-Cause Mortality
Hydroxychloroquine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/683 (0.00%)      0/677 (0.00%)    
Hide Serious Adverse Events
Hydroxychloroquine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/683 (0.44%)      2/677 (0.30%)    
Cardiac disorders     
Acute Myocardial Infarction *  1/683 (0.15%)  1 0/677 (0.00%)  0
Hepatobiliary disorders     
Haematuria *  1/683 (0.15%)  1 0/677 (0.00%)  0
Infections and infestations     
COVID-19 *  0/683 (0.00%)  0 1/677 (0.15%)  1
Psychiatric disorders     
Anxiety *  0/683 (0.00%)  0 1/677 (0.15%)  1
Suicide attempt *  1/683 (0.15%)  1 0/677 (0.00%)  0
Alcohol Use Disorder *  1/683 (0.15%)  1 0/677 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure *  0/683 (0.00%)  0 1/677 (0.15%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hydroxychloroquine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/683 (0.00%)      0/677 (0.00%)    
The study was underpowered to detect a small treatment effect. The trial was novel and improved feasibility, particularly during a pandemic. Testing was not performed at all institutions per local policies in HCW. These events were defined as suspected cases and were combined with the confirmed cases in the primary outcome. This resulted in few confirmed COVID-19 infections; thus, our primary outcome was primarily suspected COVID-19 clinical infection.
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: Dr. Susanna Naggie
Organization: Duke University
Phone: 919-684-2584
EMail: susanna.naggie@duke.edu
Layout table for additonal information
Responsible Party: Adrian Hernandez, Duke University
ClinicalTrials.gov Identifier: NCT04334148    
Other Study ID Numbers: Pro00105274
First Submitted: April 2, 2020
First Posted: April 6, 2020
Results First Submitted: October 1, 2021
Results First Posted: October 7, 2021
Last Update Posted: October 12, 2021