Covid-19
Conditions
Keywords
covid-19, healthcare workers, prophylaxis, hydroxychloroquine
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.
Interventions
DRUGHydroxychloroquine
Oral loading dose followed by once weekly dosing
OTHERVitamin C
Once daily vitamin C 1 gm
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will be masked to study assignment
Intervention model description
Open label, controlled, RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Seroconversion rate | 3 months | Percentage of healthcare worker who develop antibodies to SARS-CoV-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admission for Covid-19 | 3 months | Percentage of study subjects who require admission to a hospital for Covid-19 |
Outcome results
None listed