Status:
COMPLETED
Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers
Lead Sponsor:
Baylor Research Institute
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 expos...
Eligibility Criteria
Inclusion
- Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent
- 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.
- Afebrile with no constitutional symptoms
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures
- 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
- Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days
- 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
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
- Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- Having dermatitis, psoriasis or porphyria
- 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
- Allergies: 4-Aminoquinolines
- Pre-existing retinopathy of the eye
- Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis
- Untreated or uncontrolled active bacterial, fungal infection
- Known or suspected active drug or alcohol abuse, per investigator judgment
- Women who are pregnant or breastfeeding
- Known hypersensitivity to any component of the study drug
- 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
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT04333225
Start Date
April 3 2020
End Date
June 30 2020
Last Update
August 20 2021
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75226