Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Study Details
Study Description
Brief Summary
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort A: Healthcare worker (hydroxychloroquine)
|
Drug: Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Placebo Comparator: Cohort A: Healthcare worker (placebo)
|
Dietary Supplement: Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Experimental: Cohort B: High-Risk participant (hydroxychloroqine)
|
Drug: Hydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Placebo Comparator: Cohort B: High-Risk participant (placebo)
|
Dietary Supplement: Vitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Outcome Measures
Primary Outcome Measures
- Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test. [At enrollment completion outcome 1 will be analyzed.]
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
- Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test. [At enrollment completion outcome 2 will be analyzed.]
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion Criteria Cohort A:
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≥ 18 years old
-
Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID-19 within the last 5 days
-
Occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper Personal Protective Equipment (PPE))
-
Criteria according to Center for Disease Control (CDC) guidelines
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Community exposure (within 6 feet for at least 15 minutes)
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No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)
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No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
-
Ability to provide informed consent
Inclusion Criteria - Cohort B
-
≥ 18 years old
-
High-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a COVID-19 positive person within the last 5 days and is a South Dakota resident or high-risk person with close household contact of a COVID-19 positive Sanford employee
-
High-risk person defined by:
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Age 18-44 with 2 or more comorbidities listed below
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Age 45-79 with any comorbid condition listed below
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Age 80 and above (regardless of comorbid conditions)
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Co-morbid list
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Congestive Heart Failure (CHF)
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Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema)
-
Solid organ transplant or immunosuppression (Defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.)
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Chronic Kidney Disease or End Stage Renal Disease
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Diabetes mellitus
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Cardiovascular disease/Hypertension
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Smoking/Vaping (currently using or history of using in the past 1 year)
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Obesity (calculated by height and weight per participant report)
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Hyperlipidemia
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No current symptoms attributable to COVID-19
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No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
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Ability to provide informed consent
-
Confirmed review of concomitant medications (with emphasis on cardiac medications)
Exclusion Criteria Cohort A & B:
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Known allergy to hydroxychloroquine or quinine
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Known history of long QT syndrome
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Known history of arrhythmia or dysrhythmia
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Known current QTc >500 ms
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Known G6PD deficiency
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Known history of hypoglycemia
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Pregnant or Nursing by patient history
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Use of any of the following concomitant medications: See Appendix D for Exclusion medication list
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Concurrent diagnosis of dermatitis, porphyria, or psoriasis
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History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)
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History of chronic kidney disease
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Pre-existing retinopathy
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Already taking hydroxychloroquine
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Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine
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Enrollment in another clinical with investigational drug or device
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Inability to swallow pills
-
Adults unable to provide informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sanford Health | Sioux Falls | South Dakota | United States | 57104 |
Sponsors and Collaborators
- Sanford Health
Investigators
- Study Chair: Susan Hoover, MD, Sanford Health
Study Documents (Full-Text)
More Information
Publications
None provided.- PEPCOH
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) |
---|---|---|---|---|
Arm/Group Description | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. |
Period Title: Overall Study | ||||
STARTED | 1 | 0 | 0 | 0 |
COMPLETED | 1 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) | Total |
---|---|---|---|---|---|
Arm/Group Description | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Total of all reporting groups |
Overall Participants | 1 | 0 | 0 | 0 | 1 |
Age (Count of Participants) | |||||
<=18 years |
0
0%
|
0
NaN
|
|||
Between 18 and 65 years |
1
100%
|
1
Infinity
|
|||
>=65 years |
0
0%
|
0
NaN
|
|||
Sex: Female, Male (Count of Participants) | |||||
Female |
0
0%
|
0
NaN
|
|||
Male |
1
100%
|
1
Infinity
|
|||
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
NaN
|
|||
Not Hispanic or Latino |
0
0%
|
0
NaN
|
|||
Unknown or Not Reported |
1
100%
|
1
Infinity
|
|||
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
NaN
|
|||
Asian |
0
0%
|
0
NaN
|
|||
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
NaN
|
|||
Black or African American |
0
0%
|
0
NaN
|
|||
White |
0
0%
|
0
NaN
|
|||
More than one race |
0
0%
|
0
NaN
|
|||
Unknown or Not Reported |
1
100%
|
1
Infinity
|
|||
Region of Enrollment (participants) [Number] | |||||
United States |
1
100%
|
1
Infinity
|
Outcome Measures
Title | Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test. |
---|---|
Description | Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19. |
Time Frame | At enrollment completion outcome 1 will be analyzed. |
Outcome Measure Data
Analysis Population Description |
---|
No subject data was analyzed. Study was closed early. |
Arm/Group Title | Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) |
---|---|---|---|---|
Arm/Group Description | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. |
Measure Participants | 0 | 0 | 0 | 0 |
Title | Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test. |
---|---|
Description | Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19. |
Time Frame | At enrollment completion outcome 2 will be analyzed. |
Outcome Measure Data
Analysis Population Description |
---|
No subject data was analyzed. Study was closed early. |
Arm/Group Title | Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) |
---|---|---|---|---|
Arm/Group Description | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. |
Measure Participants | 0 | 0 | 0 | 0 |
Adverse Events
Time Frame | Adverse events were collected from Day 1 of treatment through 12 months after day 1. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine) | |||||||
Arm/Group Title | Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) | ||||
Arm/Group Description | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | ||||
All Cause Mortality |
||||||||
Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Serious Adverse Events |
||||||||
Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1 (0%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Cohort A: Healthcare Worker (Hydroxychloroquine) | Cohort A: Healthcare Worker (Placebo) | Cohort B: High-Risk Participant (Hydroxychloroqine) | Cohort B: High-Risk Participant (Placebo) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/1 (100%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Gastrointestinal disorders | ||||||||
diarrhea | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
Stomach pain | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
Infections and infestations | ||||||||
infections and infestations - Other, specify | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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
Name/Title | Dr. Susan Hoover |
---|---|
Organization | Sanford Health |
Phone | 605-328-8120 |
Susan.Hoover@sanfordhealth.org |
- PEPCOH