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Trial record 1 of 11 for:    hydroxychloroquine Minnesota | United States
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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 : Active, not recruiting
First Posted : March 31, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE March 31, 2020
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE April 6, 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
COVID-19-free survival [ Time Frame: up to 12 weeks ]
Outcome reported as the percent of participants in each arm who are COVID-19-free at the end of study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Incidence of confirmed SARS-CoV-2 detection [ Time Frame: up to 12 weeks ]
    Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.
  • Incidence of possible COVID-19 symptoms [ Time Frame: up to 12 weeks ]
    Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment.
  • Incidence of all-cause study medicine discontinuation [ Time Frame: up to 12 weeks ]
    Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.
  • 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.
  • Incidence of Hospitalization for COVID-19 or death [ Time Frame: up to 12 weeks ]
    Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.
  • Incidence of study medication-related side effects [ Time Frame: up to 12 weeks ]
    Outcome reported as the percent of participants in each arm who experience medication-related side effects during study treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-exposure Prophylaxis for SARS-Coronavirus-2
Official Title  ICMJE Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Brief Summary Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Corona Virus Infection
  • ARDS
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    Hydroxychloroquine; 200mg tablet; oral
    Other Name: Plaquenil
  • Other: Placebo
    Placebo; tablet; oral
Study Arms  ICMJE
  • 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
    Intervention: Drug: Hydroxychloroquine
  • 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
    Intervention: Drug: Hydroxychloroquine
  • 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
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
1500
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2020)
3500
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04328467
Other Study ID Numbers  ICMJE STUDY00009414
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Radha Rajasingham, MD University of Minnesota
PRS Account University of Minnesota
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP