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

Stony Brook University

Status and phase: Withdrawn; Phase 2

Conditions: Covid-19

Treatments: Other: Vitamin C; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04347889

IRB2020-00222

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Hydroxychloroquine

Experimental group

Description:

Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months

Treatment:

Drug: Hydroxychloroquine

Vitamin C

Active Comparator group

Description:

Oral Vitamin C 1,000 mg daily for three months

Treatment:

Other: Vitamin C