Back to resultsPreventing COVID-19 in Healthcare Workers With HCQ: A RCT
Primary Purpose
Covid-19
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hydroxychloroquine
Vitamin C
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 focused on measuring covid-19, healthcare workers, prophylaxis, hydroxychloroquine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydroxychloroquine
Vitamin C
Arm Description
Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months
Oral Vitamin C 1,000 mg daily for three months
Outcomes
Primary Outcome Measures
COVID-19 Seroconversion rate
Percentage of healthcare worker who develop antibodies to SARS-CoV-2
Secondary Outcome Measures
Admission for Covid-19
Percentage of study subjects who require admission to a hospital for Covid-19
Full Information
NCT ID
NCT04347889
First Posted
April 13, 2020
Last Updated
October 28, 2020
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT04347889
Brief Title
Preventing COVID-19 in Healthcare Workers With HCQ: A RCT
Official Title
Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Evidence that HCQ ineffective, loss of HCW interest,
Study Start Date
April 20, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
covid-19, healthcare workers, prophylaxis, hydroxychloroquine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open label, controlled, RCT
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be masked to study assignment
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months
Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Description
Oral Vitamin C 1,000 mg daily for three months
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Oral loading dose followed by once weekly dosing
Intervention Type
Other
Intervention Name(s)
Vitamin C
Intervention Description
Once daily vitamin C 1 gm
Primary Outcome Measure Information:
Title
COVID-19 Seroconversion rate
Description
Percentage of healthcare worker who develop antibodies to SARS-CoV-2
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Admission for Covid-19
Description
Percentage of study subjects who require admission to a hospital for Covid-19
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Preventing COVID-19 in Healthcare Workers With HCQ: A RCT
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