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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hydroxychloroquine; 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	Drug: Hydroxychloroquine; Weekly treatment in individuals at high risk; Other Names: Plaquenil; HCQ
NO_INTERVENTION: Control; Subjects who declined taking HCQ were considered as controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial	Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial	Up to 7 weeks after study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored	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	Up to 7 weeks after study initiation

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Peter A McCullough, MD, MPH, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: hydroxychloroquine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 020-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No