Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Baylor Scott and White Health (BSWH)

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT04333225

020-132

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

221 participants in 2 patient groups

Hydroxychloroquine

Experimental group

Description:

Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks

Treatment:

Drug: Hydroxychloroquine

Control

No Intervention group

Description:

Subjects who declined taking HCQ were considered as controls

Trial documents