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

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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

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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Hydroxychloroquine Other: Vitamin C Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1212 participants
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
Official Title: Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months
Drug: Hydroxychloroquine
Oral loading dose followed by once weekly dosing

Active Comparator: Vitamin C
Oral Vitamin C 1,000 mg daily for three months
Other: Vitamin C
Once daily vitamin C 1 gm




Primary Outcome Measures :
  1. COVID-19 Seroconversion rate [ Time Frame: 3 months ]
    Percentage of healthcare worker who develop antibodies to SARS-CoV-2


Secondary Outcome Measures :
  1. Admission for Covid-19 [ Time Frame: 3 months ]
    Percentage of study subjects who require admission to a hospital for Covid-19



Information from the National Library of Medicine

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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:

  • 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.
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Responsible Party: Adam Singer, Professor and Vice Chairman for Research, Stony Brook University
ClinicalTrials.gov Identifier: NCT04347889    
Other Study ID Numbers: IRB2020-00222
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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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
Keywords provided by Adam Singer, Stony Brook University:
covid-19
healthcare workers
prophylaxis
hydroxychloroquine
Additional relevant MeSH terms:
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Ascorbic Acid
Hydroxychloroquine
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antioxidants
Protective Agents