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

NCT04347889 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB2020-00222
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid-19

Keywords

covid-19; healthcare workers; prophylaxis; hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• COVID-19 Seroconversion rate

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

  3 months

Secondary Outcomes (1)

• Admission for Covid-19

  3 months

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Vitamin C

ACTIVE COMPARATOR

Oral Vitamin C 1,000 mg daily for three months

Other: Vitamin C

Interventions

Hydroxychloroquine DRUG

Oral loading dose followed by once weekly dosing

Hydroxychloroquine

Vitamin C OTHER

Once daily vitamin C 1 gm

Vitamin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare worker at risk of Covid-19

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to study assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chairman for Research

Model Details: Open label, controlled, RCT

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: April 20, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10