Official Title
A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures
Brief Summary

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

Completed
COVID-19

Drug: Hydroxychloroquine

Weekly treatment in individuals at high risk
Other Name: Array

Eligibility Criteria

Inclusion Criteria:

1. Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent

2. Healthcare workers with

• One day or more of exposure to suspect and/or positive COVID-19 patients, including
but not limited to those working in the Emergency Department or Intensive Care Unit.

OR

• Unprotected exposure to a known positive COVID-19 patient within 72 hours of
screening.

3. Afebrile with no constitutional symptoms

4. Willing and able to comply with scheduled visits, treatment plan, and other study
procedures

5. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study prior to initiation of any subject-mandated procedures

Exclusion Criteria:

1. Participation in other investigational clinical trials for the treatment or prevention
of SARS-COV-2 infection within 30days

2. Unwilling to practice acceptable methods of birth control (both males who have
partners of childbearing potential and females of childbearing potential) during
Screening, while taking study drug, and for at least 30 days after the last dose of
study drug is ingested Note: the following criteria follow standard clinical practice
for FDA approved indications of this medication

3. Having a prior history of blood disorders such as aplastic anemia, agranulocytosis,
leukopenia, or thrombocytopenia

4. Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

5. Having dermatitis, psoriasis or porphyria

6. Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and
kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs,
antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas,
amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine,
praziquantel, Pyridostigmine, tamoxifen citrate

7. Allergies: 4-Aminoquinolines

8. Pre-existing retinopathy of the eye

9. Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated
hepatitis

10. Untreated or uncontrolled active bacterial, fungal infection

11. Known or suspected active drug or alcohol abuse, per investigator judgment

12. Women who are pregnant or breastfeeding

13. Known hypersensitivity to any component of the study drug

14. A known history of prolonged QT syndrome or history of additional risk factors for
torsades de pointe (e.g., heart failure, requires a lab test , family history of Long
QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
United States
Locations

Baylor University Medical Center
Dallas, Texas, United States

Peter A McCullough, MD, MPH, Principal Investigator
Baylor Health Care System

Baylor Research Institute
NCT Number
Keywords
hydroxychloroquine
MeSH Terms
COVID-19
Hydroxychloroquine