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Pre-exposure Prophylaxis for SARS-Coronavirus-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328467
Recruitment Status : Completed
First Posted : March 31, 2020
Results First Posted : June 30, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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

Condition or disease Intervention/treatment Phase
COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome Drug: Hydroxychloroquine Other: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : July 13, 2020
Actual Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328467


Locations
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United States, Minnesota
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Radha Rajasingham, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] March 27, 2020
Informed Consent Form  [PDF] April 1, 2020

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04328467    
Other Study ID Numbers: MED-2020-28720
First Posted: March 31, 2020    Key Record Dates
Results First Posted: June 30, 2021
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Coronavirus Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents