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Purpose

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A healthcare worker at high risk for COVID-19 exposure (defined below): - Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) - Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) - Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs) - First responders (i.e. EMTs, paramedics)

Exclusion Criteria

  • Active COVID-19 disease - Prior COVID-19 disease - Current fever, cough, shortness of breath - Allergy to chloroquine or hydroxychloroquine - Prior retinal eye disease - Known Chronic Kidney disease, Stage 4 or 5 or dialysis - Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency - Weight <40 kg - Prolonged QT syndrome - Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone - Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Once Weekly 		400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
  • Drug: Hydroxychloroquine
    Hydroxychloroquine; 200mg tablet; oral
    Other names:
    • Plaquenil
Experimental
Intervention Twice Weekly 		400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
  • Drug: Hydroxychloroquine
    Hydroxychloroquine; 200mg tablet; oral
    Other names:
    • Plaquenil
Placebo Comparator
Control Group 		Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
  • Other: Placebo
    Placebo; tablet; oral

Recruiting Locations

More Details

NCT ID
NCT04328467
Status
Completed
Sponsor
University of Minnesota

Detailed Description

The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19. As of March 6, 2020, the CDC estimates that the transmission of SARS-CoV2 after a U.S. household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a setting with community transmission, the secondary attack rate in China was 35% (95%CI, 27-44%) based on 48 transmissions among 137 persons in 9 index patients. Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or reduce disease severity. It is not known at what dosing hydroxychloroquine may be effective for pre-exposure prophylaxis.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.