Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection

Sponsor
Sanford Health (Other)
Overall Status
Terminated
CT.gov ID
NCT04372017
Collaborator
(none)
1
1
4
12.7
0.1

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

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
Actual Study Start Date :
May 14, 2020
Actual Primary Completion Date :
Jun 4, 2021
Actual Study Completion Date :
Jun 4, 2021

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

  1. 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.

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Inclusion Criteria Cohort A:
  • ≥ 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

  • Community exposure (within 6 feet for at least 15 minutes)

  • No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)

  • 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:

  • Age 18-44 with 2 or more comorbidities listed below

  • Age 45-79 with any comorbid condition listed below

  • Age 80 and above (regardless of comorbid conditions)

  • Co-morbid list

  • Congestive Heart Failure (CHF)

  • 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.)

  • Chronic Kidney Disease or End Stage Renal Disease

  • Diabetes mellitus

  • Cardiovascular disease/Hypertension

  • Smoking/Vaping (currently using or history of using in the past 1 year)

  • Obesity (calculated by height and weight per participant report)

  • Hyperlipidemia

  • No current symptoms attributable to COVID-19

  • No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)

  • Ability to provide informed consent

  • Confirmed review of concomitant medications (with emphasis on cardiac medications)

Exclusion Criteria Cohort A & B:
  • Known allergy to hydroxychloroquine or quinine

  • Known history of long QT syndrome

  • Known history of arrhythmia or dysrhythmia

  • Known current QTc >500 ms

  • Known G6PD deficiency

  • Known history of hypoglycemia

  • Pregnant or Nursing by patient history

  • Use of any of the following concomitant medications: See Appendix D for Exclusion medication list

  • Concurrent diagnosis of dermatitis, porphyria, or psoriasis

  • History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)

  • History of chronic kidney disease

  • Pre-existing retinopathy

  • Already taking hydroxychloroquine

  • Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine

  • Enrollment in another clinical with investigational drug or device

  • 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.
Responsible Party:
Sanford Health
ClinicalTrials.gov Identifier:
NCT04372017
Other Study ID Numbers:
  • PEPCOH
First Posted:
May 1, 2020
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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

[Not Specified]

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
Email Susan.Hoover@sanfordhealth.org
Responsible Party:
Sanford Health
ClinicalTrials.gov Identifier:
NCT04372017
Other Study ID Numbers:
  • PEPCOH
First Posted:
May 1, 2020
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021