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OpenTrials
Completed

NCT Number: NCT04333225

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

Weekly treatment in individuals at high risk

Other names: Plaquenil, HCQ

Primary outcomes

  1. Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial

    Time frame: Up to 7 weeks after study initiation

    Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial

Secondary outcomes

  1. Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored

    Time frame: Up to 7 weeks after study initiation

    Time-to-first clinical event consisting of a persistent change for any of the following:

    • diagnosis of COVID-19
    • clinical characteristics of COVID-19 like illness
    • being censored

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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