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

• ClinicalTrials.gov Identifier: NCT04333225
• Recruitment Status: Completed
• First Posted: April 3, 2020
• Last Update Posted: January 26, 2021
• Sponsor: Baylor Research Institute
• Information provided by (Responsible Party): Baylor Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Hydroxychloroquine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 228 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures
• Actual Study Start Date: April 3, 2020
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Oral hydroxychloroquine 400 mg twice a day (two 200 mg tabs twice a day) 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
No Intervention: Control; Subjects who opt not to receive the study drug will undergo all procedures to form the control group

Outcome Measures

Primary Outcome Measures :

1. Rate of COVID-19 positive conversion [ Time Frame: 7 weeks ]
   Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling

Secondary Outcome Measures :

1. Time-to-first clinical event [ Time Frame: 7 weeks ]

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

   • One positive NP sample
   • Common clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath
   • Less common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat

Other Outcome Measures:

1. Time-to-first clinical worsening event [ Time Frame: 7 weeks ]

   Time-to-first clinical worsening event consisting of any of the following:

   • Hospitalization for COVID-19 infection
   • Intensive care unit admission for COVID-19 infection
   • All cause death

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75226

Sponsors and Collaborators

Baylor Research Institute

Investigators

• Principal Investigator: Peter A McCullough, MD, MPH; Baylor Health Care System

More Information

• Responsible Party: Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT04333225
• Other Study ID Numbers: 020-132
• First Posted: April 3, 2020
• Last Update Posted: January 26, 2021
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Baylor Research Institute:

hydroxychloroquine

Additional relevant MeSH terms:

Infection; Hydroxychloroquine; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents