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

NCT ID: NCT04333225

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2020-06-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Weekly treatment in individuals at high risk

Control

Subjects who declined taking HCQ were considered as controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hydroxychloroquine

Weekly treatment in individuals at high risk

Intervention Type: DRUG

Other Intervention Names

Plaquenil; HCQ

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter A McCullough, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

020-132

Identifier Type: -

Identifier Source: org_study_id