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Completed

NCT Number: NCT04328467

Pre-exposure Prophylaxis for SARS-Coronavirus-2

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

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Key information

Conditions

COVID-19 ARDS Acute Respiratory Distress Syndrome Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nationwide Enrollment via Internet, please email: [email protected], Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine; 200mg tablet; oral

Other names: Plaquenil

Placebo

Other

Placebo; tablet; oral

Primary outcomes

  1. COVID-19-free Survival

    Time frame: up to 12 weeks

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

Secondary outcomes

  1. Number of Confirmed SARS-CoV-2 Detection

    Time frame: up to 12 weeks

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

  2. Incidence of Possible COVID-19 Symptoms

    Time frame: up to 12 weeks

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

  3. Incidence of All-cause Study Medicine Discontinuation

    Time frame: up to 12 weeks

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

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

    Time frame: up to 12 weeks

    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.

  5. Incidence of Hospitalization for COVID-19 or Death

    Time frame: up to 12 weeks

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

  6. Incidence of Possible Study Medication-related Side Effects

    Time frame: up to 12 weeks

    Outcome reported as the number of participants in each arm who experience possible medication-related side effects during study treatment.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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