Pre-exposure Prophylaxis for SARS-Coronavirus-2

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 3

Conditions

COVID-19
Corona Virus Infection
Acute Respiratory Distress Syndrome
ARDS

Treatments

Drug: Hydroxychloroquine
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04328467
MED-2020-28720

Details and patient eligibility

About

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

Full 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.

Enrollment

1,483 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,483 participants in 3 patient groups, including a placebo group

Intervention Once Weekly
Experimental group
Description:
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
Treatment:
Drug: Hydroxychloroquine
Intervention Twice Weekly
Experimental group
Description:
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
Treatment:
Drug: Hydroxychloroquine
Control Group
Placebo Comparator group
Description:
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
Treatment:
Other: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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