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Preventing COVID-19 in Healthcare Workers With HCQ: A RCT

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347889
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date April 17, 2020
Estimated Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
COVID-19 Seroconversion rate [ Time Frame: 3 months ]
Percentage of healthcare worker who develop antibodies to SARS-CoV-2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
Admission for Covid-19 [ Time Frame: 3 months ]
Percentage of study subjects who require admission to a hospital for Covid-19
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 Preventing COVID-19 in Healthcare Workers With HCQ: A RCT
Official Title  ICMJE Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT
Brief Summary Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
Detailed Description Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open label, controlled, RCT
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will be masked to study assignment
Primary Purpose: Prevention
Condition  ICMJE Covid-19
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    Oral loading dose followed by once weekly dosing
  • Other: Vitamin C
    Once daily vitamin C 1 gm
Study Arms  ICMJE
  • Experimental: Hydroxychloroquine
    Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months
    Intervention: Drug: Hydroxychloroquine
  • Active Comparator: Vitamin C
    Oral Vitamin C 1,000 mg daily for three months
    Intervention: Other: Vitamin C
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
1212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthcare worker at risk of Covid-19

Exclusion Criteria:

  • Known hypersensitivity or allergic reactions to 4-aminoquinoline compounds or its ingredients.
  • Current, or history of, ocular macular disease or retinal damage.
  • Current, or history of, subnormal glomerular filtration.
  • Current use of tamoxifen citrate.
  • Current, or history of, cardiomyopathy, atrial, nodal, or ventricular arrhythmias, torsades de pointes, conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy.
  • Subjects taking other drugs that have the potential to prolong QT interval if taken with HCQ.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04347889
Other Study ID Numbers  ICMJE IRB2020-00222
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adam Singer, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stony Brook University
Verification Date April 2020

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