COVID-19, SARS-CoV 2
Conditions
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.
Interventions
DRUGHydroxychloroquine
Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
DIETARY_SUPPLEMENTVitamin D
Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
Sponsors
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Healthcare Worker (Hydroxychloroquine) Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | 1 |
| Cohort A: Healthcare Worker (Placebo) Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | 0 |
| Cohort B: High-Risk Participant (Hydroxychloroqine) Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5. | 0 |
| Cohort B: High-Risk Participant (Placebo) Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Cohort A: Healthcare Worker (Hydroxychloroquine) | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.
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.
Population: No subject data was analyzed. Study was closed early.
Primary
Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.
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.
Population: No subject data was analyzed. Study was closed early.