Pre-exposure Prophylaxis for SARS-Coronavirus-2

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-06

Study Completion Date

2020-07-13

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine; 200mg tablet; oral

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

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine; 200mg tablet; oral

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo; tablet; oral

Interventions

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Hydroxychloroquine

Hydroxychloroquine; 200mg tablet; oral

Intervention Type DRUG

Placebo

Placebo; tablet; oral

Intervention Type OTHER

Other Intervention Names

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Plaquenil

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No