NCT04347889 - Preventing COVID-19 in Healthcare Workers With HCQ: A RCT | Crick

Overview

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Covid-19

Interventions

HydroxychloroquineDRUG

Oral loading dose followed by once weekly dosing

Vitamin COTHER

Once daily vitamin C 1 gm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

COVID-19 Seroconversion rate

Percentage of healthcare worker who develop antibodies to SARS-CoV-2

Time frame: 3 months

Secondary Outcomes

Admission for Covid-19

Percentage of study subjects who require admission to a hospital for Covid-19

Time frame: 3 months