Pre-exposure Prophylaxis for SARS-Coronavirus-2

University of Minnesota1,483 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,483

Conditions

COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine; 200mg tablet; oral

PlaceboOTHER

Placebo; tablet; oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Nationwide Enrollment via Internet, please email: covid19@umn.edu

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

COVID-19-free Survival

Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.

Time frame: up to 12 weeks

Secondary Outcomes

Number of Confirmed SARS-CoV-2 Detection

Outcome reported as the number of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.

Time frame: up to 12 weeks

Incidence of Possible COVID-19 Symptoms

Outcome reported as the count of participants in each arm who report COVID-19-related symptoms during study treatment.

Time frame: up to 12 weeks

Incidence of All-cause Study Medicine Discontinuation

Outcome reported as the count of participants in each arm who discontinue study medication use for any reason during treatment.

Time frame: up to 12 weeks

Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End

Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.

Time frame: up to 12 weeks

Incidence of Hospitalization for COVID-19 or Death

Outcome reported as the number of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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