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

Phase 2

Withdrawn

• Conditions: Covid-19
• Interventions: Other: Vitamin C; Drug: Hydroxychloroquine

• Registration Number: NCT04347889
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2020-04-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-11-02
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	Vitamin C	Oral Vitamin C 1,000 mg daily for three months
Hydroxychloroquine	Hydroxychloroquine	Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months

Primary Outcome Measures

Name	Time	Method
COVID-19 Seroconversion rate	3 months	Percentage of healthcare worker who develop antibodies to SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
Admission for Covid-19	3 months	Percentage of study subjects who require admission to a hospital for Covid-19