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

NCT04333225 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 020-132
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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

Keywords

hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 7 weeks after study initiation

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

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

Control

NO INTERVENTION

Subjects who declined taking HCQ were considered as controls

Interventions

Hydroxychloroquine DRUG

Weekly treatment in individuals at high risk

Also known as: Plaquenil, HCQ

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

* Due to the off-label use of HCQ, we were not able to incorporate randomization in our design. * The outcome of CLI was based on self-reported symptoms, which is prone to bias. * The trial may be under-powered as recruitment was forced to stop early at 221 instead of 360 because of the demand for and subsequent shortage of HCQ in March 2020. * Our study participants were young and healthy compared to other prophylaxis trials, which may partially explain the low rates of COVID-19.

Results Point of Contact

• Title: Peter A. McCullough, MD, MPH
• Organization: Baylor Scott & White Research Institute

peteramccullough@gmail.com

2148412000

Study Officials

• Peter A McCullough, MD, MPH

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: April 3, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 20, 2021
• Results First Posted: August 20, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)